Sertraline Hydrochloride

Product NDC: 31722-212
11-digit product format: 317220212
Labeler code: 31722
Product ID: 31722-212_5616a898-fc8c-4bc5-87eb-62084fea396d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sertraline Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Camber Pharmaceuticals Inc.
Application: ANDA077397
Marketing category: ANDA
Marketing start: 2007-10-18
Marketing end: 0000-00-00
Substance: SERTRALINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	31722-212		D	Discontinued by firm	2026-08-10
excluded package	package	31722-212	31722-212-05	D	Discontinued by firm	2026-08-10
excluded package	package	31722-212	31722-212-30	D	Discontinued by firm	2026-08-10
excluded package	package	31722-212	31722-212-90	D	Discontinued by firm	2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 88 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	31722-212-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	31722-212-90	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	31722-212-30	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	31722-212-05	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	31722-212-90	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	31722-212-30	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	31722-212-90	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	31722-212-05	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	31722-212-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	31722-212-90	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	31722-212-05	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	31722-212-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	31722-212-90	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	31722-212-05	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	31722-212-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	31722-212-90	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	31722-212-05	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	31722-212-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	31722-212-90	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	31722-212-05	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	31722-212-30	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	31722-212-90	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	31722-212-05	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	31722-212-30	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	31722-212-90	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	31722-212-05	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	31722-212-30	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	31722-212-90	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	31722-212-05	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	31722-212-30	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	31722-212-90	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	31722-212-05	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	31722-212-30	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	31722-212-90	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	31722-212-05	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	31722-212-30	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	31722-212-90	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	31722-212-05	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	31722-212-30	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	31722-212-90	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	31722-212-05	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	31722-212-30	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	31722-212-90	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	31722-212-05	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	31722-212-30	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077397-001	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06
A077397-002	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06
A077397-003	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077397-001	AB
A077397-002	AB
A077397-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077397-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077397-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077397-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077397-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077397-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077397-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077397-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077397-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077397-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077397-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077397-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077397-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077397-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077397-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077397-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077397-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077397-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077397-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077397-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077397-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077397-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077397-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077397-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077397-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077397-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077397-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077397-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077397-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077397-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077397-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077397-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077397-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077397-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077397-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077397-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077397-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077397-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077397-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077397-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077397-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077397-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077397-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077397-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077397-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077397-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077397-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077397-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077397-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077397-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077397-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077397-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077397-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077397-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077397-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077397-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077397-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077397-002	AB	1	`03ed91905a0d…`
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2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077397-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077397-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077397-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077397-001	AB	1	`5bbf6a4d5a75…`
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2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077397-001	AB	1	`d8e5a09893c0…`
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2024-10-29 15:01 UTC	2024-10	A077397-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077397-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077397-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077397-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077397-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077397-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077397-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077397-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077397-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077397-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077397-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077397-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077397-001	AB	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4ac594ea-ad8b-47fd-9b52-bbd98301675e	Product name	1	20220317
255fa467-900b-5557-4215-6823352d1150	Product name	2	20211028

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
31722-212-05	2025-06-19	Sertraline Hydrochloride Tablets 25 mg, 50 mg and 100 mg
31722-212-30	2025-06-19	Sertraline Hydrochloride Tablets 25 mg, 50 mg and 100 mg
31722-212-90	2025-06-19	Sertraline Hydrochloride Tablets 25 mg, 50 mg and 100 mg
31722-212-05	2019-11-27	Sertraline Hydrochloride Tablets 25 mg, 50 mg and 100 mg
31722-212-30	2019-11-27	Sertraline Hydrochloride Tablets 25 mg, 50 mg and 100 mg
31722-212-90	2019-11-27	Sertraline Hydrochloride Tablets 25 mg, 50 mg and 100 mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-212-05	EA - Each	31722-212	51b56965-93e8-4070-8f20-3f58cc5fbadb	1	2013-02-13
31722-212-30	EA - Each	31722-212	2c917e38-ea6a-4e71-bcfc-3c5776cfd7ad	1	2013-02-13
31722-212-90	EA - Each	31722-212	9089644c-aab5-4cee-a4e4-cd54db23d3be	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SERTRALINE HYDROCHLORIDE	ACTIVE INGREDIENT	UTI8907Y6X	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	27
SERTRALINE	ACTIVE MOIETY	QUC7NX6WMB	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	27
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	27
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	27
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	27
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	27
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	27
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	27
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	27
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	27
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	27
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	27
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	27
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	27
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	27
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	27
SERTRALINE HYDROCHLORIDE	ACTIVE INGREDIENT	UTI8907Y6X	SERTRALINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	4
SERTRALINE	ACTIVE MOIETY	QUC7NX6WMB	SERTRALINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SERTRALINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SERTRALINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SERTRALINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SERTRALINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SERTRALINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	4
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	SERTRALINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	4
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	SERTRALINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SERTRALINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	4
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	SERTRALINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SERTRALINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SERTRALINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SERTRALINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	4
SERTRALINE HYDROCHLORIDE	ACTIVE INGREDIENT	UTI8907Y6X	SERTRALINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
SERTRALINE HYDROCHLORIDE	ACTIVE INGREDIENT	UTI8907Y6X	SERTRALINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.]	3
SERTRALINE	ACTIVE MOIETY	QUC7NX6WMB	SERTRALINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
SERTRALINE	ACTIVE MOIETY	QUC7NX6WMB	SERTRALINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.]	3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SERTRALINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SERTRALINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SERTRALINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SERTRALINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SERTRALINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SERTRALINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	SERTRALINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	SERTRALINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SERTRALINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	SERTRALINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SERTRALINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SERTRALINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SERTRALINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
SERTRALINE HYDROCHLORIDE	ACTIVE INGREDIENT	UTI8907Y6X	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SERTRALINE HYDROCHLORIDE	ACTIVE INGREDIENT	UTI8907Y6X	SERTRALINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC.]	2
SERTRALINE	ACTIVE MOIETY	QUC7NX6WMB	SERTRALINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC.]	2
SERTRALINE	ACTIVE MOIETY	QUC7NX6WMB	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SERTRALINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SERTRALINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC.]	2
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SERTRALINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SERTRALINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SERTRALINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SERTRALINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SERTRALINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC.]	2
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	SERTRALINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC.]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	SERTRALINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SERTRALINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	SERTRALINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SERTRALINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC.]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SERTRALINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SERTRALINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SERTRALINE HYDROCHLORIDE	ACTIVE INGREDIENT	UTI8907Y6X	SERTRALINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SERTRALINE HYDROCHLORIDE	ACTIVE INGREDIENT	UTI8907Y6X	SERTRALINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
SERTRALINE HYDROCHLORIDE	ACTIVE INGREDIENT	UTI8907Y6X	SERTRALINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	1
SERTRALINE HYDROCHLORIDE	ACTIVE INGREDIENT	UTI8907Y6X	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SERTRALINE	ACTIVE MOIETY	QUC7NX6WMB	SERTRALINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
SERTRALINE	ACTIVE MOIETY	QUC7NX6WMB	SERTRALINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SERTRALINE	ACTIVE MOIETY	QUC7NX6WMB	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SERTRALINE	ACTIVE MOIETY	QUC7NX6WMB	SERTRALINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SERTRALINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SERTRALINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SERTRALINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SERTRALINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SERTRALINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SERTRALINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SERTRALINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	1
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SERTRALINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SERTRALINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SERTRALINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SERTRALINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SERTRALINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SERTRALINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SERTRALINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SERTRALINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SERTRALINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SERTRALINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	SERTRALINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	SERTRALINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	1
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	SERTRALINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	SERTRALINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	SERTRALINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	SERTRALINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SERTRALINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SERTRALINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SERTRALINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	SERTRALINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	SERTRALINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	SERTRALINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SERTRALINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SERTRALINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SERTRALINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SERTRALINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SERTRALINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SERTRALINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SERTRALINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SERTRALINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SERTRALINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-212	SERTRALINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC.]	2	Legacy NDC	20130222_983f8b2c-89ff-4519-b0f6-db3d17b3a3e7.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Coupler LLC	56442b06-c135-a035-e063-6394a90a171b	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Legacy Pharmaceutical Packaging, LLC	bd86b293-dab9-4d37-95eb-2bffca335d16	2026-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Quallent Pharmaceuticals Health LLC	61835f25-bfe4-49ac-9dbf-3d6387866e78	2026-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Cipla USA Inc.	cf71d1b9-5ebb-429f-a07f-a87cd168250f	2026-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Northwind Health Company, LLC	ab30b0a4-6696-19da-e053-2995a90a29aa	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Cardinal Health 107, LLC	7e5e76cf-2fda-4f9d-bcbf-f77b1f188ee6	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	52c88667-c67e-4d42-b319-afb354713b1e	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	adfcc867-1b6e-4698-94b6-2b4190c4ba3d	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
SERTRALINE	SERTRALINE	Aphena Pharma Solutions - Tennessee, LLC	1548faf9-8625-f871-e063-6394a90a931f	2025-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	REMEDYREPACK INC.	7d598f1a-6c76-458a-a155-7a6a0743a2d3	2025-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	30b94d67-0000-a045-e063-6394a90ade32	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	American Health Packaging	4e09f580-d612-416c-a4a4-79a4411845b2	2024-11-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7cadc747-5606-8efe-e053-2991aa0a1d8f	2024-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	22c4b114-5f70-4c64-aa7f-b4169729b847	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	9bcef7ef-4e2f-4ab9-9c0f-f4956bfdd71b	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
SERTRALINE	SERTRALINE	Aphena Pharma Solutions - Tennessee, LLC	7be6a62e-0e85-47c8-8793-b41c51c2557f	2024-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Proficient Rx LP	787a683a-091c-4908-a643-ecbc8fd467eb	2020-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Proficient Rx LP	00179766-980b-44b0-99d3-1fee2bb27e37	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Proficient Rx LP	551d5946-00df-4608-96a2-b29f0ef93ba0	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UTI8907Y6X	SERTRALINE HYDROCHLORIDE	79559-97-0	SERTRALINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312940	sertraline HCl 25 MG Oral Tablet	PSN	3923bb17-cc93-4410-bf94-76c4600f63ee	4
312940	sertraline HCl 25 MG Oral Tablet	PSN	1b92d9ce-ba64-47da-8d3d-40a2ee12e5f4	4
312941	sertraline HCl 50 MG Oral Tablet	PSN	3923bb17-cc93-4410-bf94-76c4600f63ee	4
312940	sertraline 25 MG Oral Tablet	SCD	1b92d9ce-ba64-47da-8d3d-40a2ee12e5f4	4
312940	sertraline 25 MG Oral Tablet	SCD	3923bb17-cc93-4410-bf94-76c4600f63ee	4
312941	sertraline 50 MG Oral Tablet	SCD	3923bb17-cc93-4410-bf94-76c4600f63ee	4
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	1b92d9ce-ba64-47da-8d3d-40a2ee12e5f4	4
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	3923bb17-cc93-4410-bf94-76c4600f63ee	4
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	3923bb17-cc93-4410-bf94-76c4600f63ee	4
312938	sertraline HCl 100 MG Oral Tablet	PSN	5365e9a7-ad09-4a85-95a1-a86f40c890a5	3
312940	sertraline HCl 25 MG Oral Tablet	PSN	5365e9a7-ad09-4a85-95a1-a86f40c890a5	3
312941	sertraline HCl 50 MG Oral Tablet	PSN	5365e9a7-ad09-4a85-95a1-a86f40c890a5	3
312938	sertraline 100 MG Oral Tablet	SCD	5365e9a7-ad09-4a85-95a1-a86f40c890a5	3
312940	sertraline 25 MG Oral Tablet	SCD	5365e9a7-ad09-4a85-95a1-a86f40c890a5	3
312941	sertraline 50 MG Oral Tablet	SCD	5365e9a7-ad09-4a85-95a1-a86f40c890a5	3
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	5365e9a7-ad09-4a85-95a1-a86f40c890a5	3
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	5365e9a7-ad09-4a85-95a1-a86f40c890a5	3
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	5365e9a7-ad09-4a85-95a1-a86f40c890a5	3
312938	sertraline HCl 100 MG Oral Tablet	PSN	c0724513-693c-42cf-9b25-d5394cc32d7c	1
312938	sertraline HCl 100 MG Oral Tablet	PSN	232a00a4-761e-422f-b62a-1a16de631eb6	1
312940	sertraline HCl 25 MG Oral Tablet	PSN	232a00a4-761e-422f-b62a-1a16de631eb6	1
312940	sertraline HCl 25 MG Oral Tablet	PSN	c0724513-693c-42cf-9b25-d5394cc32d7c	1
312940	sertraline HCl 25 MG Oral Tablet	PSN	80adf27d-60fb-4394-8881-e75d3acb2774	1
312941	sertraline HCl 50 MG Oral Tablet	PSN	232a00a4-761e-422f-b62a-1a16de631eb6	1
312941	sertraline HCl 50 MG Oral Tablet	PSN	c0724513-693c-42cf-9b25-d5394cc32d7c	1
312941	sertraline HCl 50 MG Oral Tablet	PSN	80adf27d-60fb-4394-8881-e75d3acb2774	1
312938	sertraline 100 MG Oral Tablet	SCD	232a00a4-761e-422f-b62a-1a16de631eb6	1
312938	sertraline 100 MG Oral Tablet	SCD	c0724513-693c-42cf-9b25-d5394cc32d7c	1
312940	sertraline 25 MG Oral Tablet	SCD	232a00a4-761e-422f-b62a-1a16de631eb6	1
312940	sertraline 25 MG Oral Tablet	SCD	c0724513-693c-42cf-9b25-d5394cc32d7c	1
312940	sertraline 25 MG Oral Tablet	SCD	80adf27d-60fb-4394-8881-e75d3acb2774	1
312941	sertraline 50 MG Oral Tablet	SCD	232a00a4-761e-422f-b62a-1a16de631eb6	1
312941	sertraline 50 MG Oral Tablet	SCD	c0724513-693c-42cf-9b25-d5394cc32d7c	1
312941	sertraline 50 MG Oral Tablet	SCD	80adf27d-60fb-4394-8881-e75d3acb2774	1
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	c0724513-693c-42cf-9b25-d5394cc32d7c	1
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	232a00a4-761e-422f-b62a-1a16de631eb6	1
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	c0724513-693c-42cf-9b25-d5394cc32d7c	1
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	80adf27d-60fb-4394-8881-e75d3acb2774	1
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	232a00a4-761e-422f-b62a-1a16de631eb6	1
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	c0724513-693c-42cf-9b25-d5394cc32d7c	1
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	232a00a4-761e-422f-b62a-1a16de631eb6	1
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	80adf27d-60fb-4394-8881-e75d3acb2774	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sertraline Hydrochloride Tablets 25 mg, 50 mg and 100 mg	Unit Dose Services	2017-07-21	HUMAN PRESCRIPTION DRUG LABEL	4
Sertraline Hydrochloride Tablets 25 mg, 50 mg and 100 mg	Preferred Pharmaceuticals, Inc.	2016-08-24	HUMAN PRESCRIPTION DRUG LABEL	4
Sertraline Hydrochloride Tablets 25 mg, 50 mg and 100 mg	Aphena Pharma Solutions - Tennessee, LLC	2016-06-16	HUMAN PRESCRIPTION DRUG LABEL	1
Sertraline Tablets, USP 25 mg, 50 mg and 100 mg Rx Only	NCS HealthCare of KY, Inc dba Vangard Labs	2015-01-20	HUMAN PRESCRIPTION DRUG LABEL	27
Sertraline Hydrochloride Tablets 25 mg, 50 mg and 100 mg	Aidarex Pharmaceuticals LLC	2014-01-31	HUMAN PRESCRIPTION DRUG LABEL	1
Sertraline Hydrochloride Tablets 25 mg, 50 mg and 100 mg	TYA Pharmaceuticals	2013-02-06	HUMAN PRESCRIPTION DRUG LABEL	4
Sertraline Hydrochloride Tablets 25 mg, 50 mg and 100 mg	Camber Pharmaceuticals Inc. \| InvaGen Pharmceuticals Inc.	2013-02-06	HUMAN PRESCRIPTION DRUG LABEL	2
Sertraline Hydrochloride Tablets 25 mg, 50 mg and 100 mg	H.J. Harkins Company Inc. \| InvaGen Pharmceuticals Inc.	2011-12-20	HUMAN PRESCRIPTION DRUG LABEL	3
Sertraline Hydrochloride Tablets 25 mg, 50 mg and 100 mg	STAT Rx USA LLC	2011-10-05	HUMAN PRESCRIPTION DRUG LABEL	1
Sertraline Hydrochloride Tablets	Rebel Distributors Corp	2010-12-01	HUMAN PRESCRIPTION DRUG LABEL	1
Sertraline Hydrochloride Tablets	State of Florida DOH Central Pharmacy	2010-08-04	HUMAN PRESCRIPTION DRUG LABEL	2