Sertraline Hydrochloride

Product NDC: 63304-167
11-digit product format: 633040167
Labeler code: 63304
Product ID: 63304-167_d75e7077-98f9-41d8-860c-39d556cc7a1b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sertraline Hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Ranbaxy Pharmaceuticals Inc.
Application: ANDA077977
Marketing category: ANDA
Marketing start: 2007-02-06
Marketing end: 0000-00-00
Substance: SERTRALINE HYDROCHLORIDE
Active strength: 150 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63304-167		I	Inactivated by FDA	2026-10-16
excluded package	package	63304-167	63304-167-03	I	Inactivated by FDA	2026-10-16
excluded package	package	63304-167	63304-167-10	I	Inactivated by FDA	2026-10-16

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 · 63 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63304-167-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63304-167-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63304-167-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63304-167-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63304-167-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63304-167-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63304-167-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63304-167-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63304-167-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63304-167-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63304-167-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63304-167-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63304-167-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63304-167-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63304-167-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63304-167-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63304-167-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63304-167-03	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63304-167-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63304-167-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63304-167-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63304-167-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63304-167-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63304-167-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63304-167-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63304-167-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63304-167-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63304-167-03	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63304-167-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63304-167-03	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63304-167-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63304-167-03	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63304-167-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63304-167-03	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	63304-167-10	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	63304-167-03	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63304-167-10	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63304-167-03	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63304-167-10	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63304-167-03	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077977-001	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06
A077977-002	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06
A077977-003	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06
A077977-004	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-02-06
A077977-005	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	2007-02-06

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 2 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077977-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077977-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077977-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077977-004	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077977-005	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	2007-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077977-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077977-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077977-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077977-004	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077977-005	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	2007-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077977-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077977-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077977-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077977-004	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077977-005	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	2007-02-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077977-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077977-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077977-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077977-004	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-02-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077977-005	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	2007-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077977-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077977-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077977-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077977-004	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077977-005	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	2007-02-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077977-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077977-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077977-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077977-004	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-02-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077977-005	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	2007-02-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077977-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077977-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077977-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077977-004	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-02-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077977-005	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	2007-02-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077977-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077977-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077977-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077977-004	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-02-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077977-005	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	2007-02-06	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077977-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077977-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077977-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077977-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077977-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077977-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077977-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077977-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077977-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077977-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077977-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077977-003	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63304-167-03	2020-01-31	C162847	48780-1	9d75b9cf-d175-f424-e053-dadaa90a57ce	SERTRALINE HYDROCHLORIDE TABLETS Rx only
63304-167-10	2020-01-31	C162847	48780-1	9d75b9cf-d175-f424-e053-dadaa90a57ce	SERTRALINE HYDROCHLORIDE TABLETS Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63304-167-03	Sertraline Hydrochloride	10 in 1 BOTTLE	TABLET, COATED	10		6
63304-167-10	Sertraline Hydrochloride	1000 in 1 BOTTLE	TABLET, COATED	1000		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SERTRALINE HYDROCHLORIDE	ACTIVE INGREDIENT	UTI8907Y6X	SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]	5
SERTRALINE	ACTIVE MOIETY	QUC7NX6WMB	SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]	5
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]	5
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63304-167	SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.]	6	Legacy NDC, 2 package rows	20160108_c25f968b-7037-4f60-9a02-2189769b0cbf.zip

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
312938	sertraline HCl 100 MG Oral Tablet	PSN	c25f968b-7037-4f60-9a02-2189769b0cbf	6
794947	sertraline HCl 150 MG Oral Tablet	PSN	c25f968b-7037-4f60-9a02-2189769b0cbf	6
251200	sertraline HCl 200 MG Oral Tablet	PSN	c25f968b-7037-4f60-9a02-2189769b0cbf	6
312940	sertraline HCl 25 MG Oral Tablet	PSN	c25f968b-7037-4f60-9a02-2189769b0cbf	6
312941	sertraline HCl 50 MG Oral Tablet	PSN	c25f968b-7037-4f60-9a02-2189769b0cbf	6
312938	sertraline 100 MG Oral Tablet	SCD	c25f968b-7037-4f60-9a02-2189769b0cbf	6
794947	sertraline 150 MG Oral Tablet	SCD	c25f968b-7037-4f60-9a02-2189769b0cbf	6
251200	sertraline 200 MG Oral Tablet	SCD	c25f968b-7037-4f60-9a02-2189769b0cbf	6
312940	sertraline 25 MG Oral Tablet	SCD	c25f968b-7037-4f60-9a02-2189769b0cbf	6
312941	sertraline 50 MG Oral Tablet	SCD	c25f968b-7037-4f60-9a02-2189769b0cbf	6
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	c25f968b-7037-4f60-9a02-2189769b0cbf	6
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	c25f968b-7037-4f60-9a02-2189769b0cbf	6
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	c25f968b-7037-4f60-9a02-2189769b0cbf	6
794947	sertraline (as sertraline hydrochloride) 150 MG Oral Tablet	SY	c25f968b-7037-4f60-9a02-2189769b0cbf	6
251200	sertraline (as sertraline hydrochloride) 200 MG Oral Tablet	SY	c25f968b-7037-4f60-9a02-2189769b0cbf	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
63304-167-03	63304016703	10 in 1 BOTTLE	Historical
63304-167-10	63304016710	1000 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SERTRALINE HYDROCHLORIDE TABLETS Rx only	Ranbaxy Pharmaceuticals Inc. \| Ohm Laboratories Inc.	2016-01-07	HUMAN PRESCRIPTION DRUG LABEL	6