Escitalopram

Product NDC: 31722-249
11-digit product format: 317220249
Labeler code: 31722
Product ID: 31722-249_e280a343-4949-4c92-96f7-5744d8cf52c9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Escitalopram
Dosage form: TABLET
Route: ORAL
Labeler: Camber Pharmaceuticals
Application: ANDA078604
Marketing category: ANDA
Marketing start: 2012-09-11
Marketing end: 0000-00-00
Substance: ESCITALOPRAM OXALATE
Active strength: 5 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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	31722-249		D	Discontinued by firm	2026-08-17
excluded package	package	31722-249	31722-249-01	D	Discontinued by firm	2026-08-17
excluded package	package	31722-249	31722-249-05	D	Discontinued by firm	2026-08-17
excluded package	package	31722-249	31722-249-10	D	Discontinued by firm	2026-08-17
excluded package	package	31722-249	31722-249-30	D	Discontinued by firm	2026-08-17
excluded package	package	31722-249	31722-249-90	D	Discontinued by firm	2026-08-17

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 3 · 132 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	31722-249-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	31722-249-10	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	31722-249-30	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	31722-249-90	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	31722-249-01	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	31722-249-05	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	31722-249-10	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	31722-249-30	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	31722-249-90	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	31722-249-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	31722-249-05	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	31722-249-10	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	31722-249-30	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	31722-249-90	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	31722-249-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	31722-249-05	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	31722-249-10	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	31722-249-30	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	31722-249-90	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	31722-249-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	31722-249-05	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	31722-249-10	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	31722-249-30	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	31722-249-90	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	31722-249-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	31722-249-05	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	31722-249-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	31722-249-30	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	31722-249-90	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	31722-249-01	D	Discontinued by firm	`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	31722-249-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	31722-249-30	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	31722-249-05	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	31722-249-90	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	31722-249-10	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	31722-249-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	31722-249-30	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	31722-249-05	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	31722-249-90	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	31722-249-10	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	31722-249-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	31722-249-30	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	31722-249-05	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	31722-249-90	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	31722-249-10	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	31722-249-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	31722-249-30	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	31722-249-05	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	31722-249-90	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	31722-249-10	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078604-001	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11
A078604-002	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11
A078604-003	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078604-001	AB
A078604-002	AB
A078604-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078604-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078604-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078604-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078604-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078604-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078604-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078604-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078604-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078604-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078604-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078604-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078604-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078604-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078604-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078604-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078604-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078604-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078604-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078604-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078604-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078604-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078604-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078604-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078604-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078604-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078604-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078604-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078604-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078604-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078604-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078604-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078604-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078604-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078604-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078604-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078604-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078604-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078604-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078604-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078604-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078604-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078604-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078604-001	AB	1	`1e350fbaab3a…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
31722-249-01	2025-02-19	Escitalopram Tablets, USP These highlights do not include all the information needed to use Escitalopram safely and effectively. See full prescribing information for Escitalopram. Escitalopram (Escitalopram) TABLET for ORAL use. Initial U.S. Approval: 2002
31722-249-05	2025-02-19	Escitalopram Tablets, USP These highlights do not include all the information needed to use Escitalopram safely and effectively. See full prescribing information for Escitalopram. Escitalopram (Escitalopram) TABLET for ORAL use. Initial U.S. Approval: 2002
31722-249-10	2025-02-19	Escitalopram Tablets, USP These highlights do not include all the information needed to use Escitalopram safely and effectively. See full prescribing information for Escitalopram. Escitalopram (Escitalopram) TABLET for ORAL use. Initial U.S. Approval: 2002
31722-249-30	2025-02-19	Escitalopram Tablets, USP These highlights do not include all the information needed to use Escitalopram safely and effectively. See full prescribing information for Escitalopram. Escitalopram (Escitalopram) TABLET for ORAL use. Initial U.S. Approval: 2002
31722-249-90	2025-02-19	Escitalopram Tablets, USP These highlights do not include all the information needed to use Escitalopram safely and effectively. See full prescribing information for Escitalopram. Escitalopram (Escitalopram) TABLET for ORAL use. Initial U.S. Approval: 2002
31722-249-01	2019-11-13	Escitalopram Tablets, USP These highlights do not include all the information needed to use Escitalopram safely and effectively. See full prescribing information for Escitalopram. Escitalopram (Escitalopram) TABLET for ORAL use. Initial U.S. Approval: 2002
31722-249-05	2019-11-13	Escitalopram Tablets, USP These highlights do not include all the information needed to use Escitalopram safely and effectively. See full prescribing information for Escitalopram. Escitalopram (Escitalopram) TABLET for ORAL use. Initial U.S. Approval: 2002
31722-249-10	2019-11-13	Escitalopram Tablets, USP These highlights do not include all the information needed to use Escitalopram safely and effectively. See full prescribing information for Escitalopram. Escitalopram (Escitalopram) TABLET for ORAL use. Initial U.S. Approval: 2002
31722-249-30	2019-11-13	Escitalopram Tablets, USP These highlights do not include all the information needed to use Escitalopram safely and effectively. See full prescribing information for Escitalopram. Escitalopram (Escitalopram) TABLET for ORAL use. Initial U.S. Approval: 2002
31722-249-90	2019-11-13	Escitalopram Tablets, USP These highlights do not include all the information needed to use Escitalopram safely and effectively. See full prescribing information for Escitalopram. Escitalopram (Escitalopram) TABLET for ORAL use. Initial U.S. Approval: 2002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-249-90	EA - Each	31722-249	248dcd61-bb97-409c-98ef-649738105c67	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESCITALOPRAM OXALATE	ACTIVE INGREDIENT	5U85DBW7LO	ESCITALOPRAM TABLET [CAMBER PHARMACEUTICALS]	1
ESCITALOPRAM	ACTIVE MOIETY	4O4S742ANY	ESCITALOPRAM TABLET [CAMBER PHARMACEUTICALS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ESCITALOPRAM TABLET [CAMBER PHARMACEUTICALS]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ESCITALOPRAM TABLET [CAMBER PHARMACEUTICALS]	1
HYPROMELLOSE 2208 (3 MPA.S)	INACTIVE INGREDIENT	9H4L916OBU	ESCITALOPRAM TABLET [CAMBER PHARMACEUTICALS]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	ESCITALOPRAM TABLET [CAMBER PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESCITALOPRAM TABLET [CAMBER PHARMACEUTICALS]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ESCITALOPRAM TABLET [CAMBER PHARMACEUTICALS]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ESCITALOPRAM TABLET [CAMBER PHARMACEUTICALS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ESCITALOPRAM TABLET [CAMBER PHARMACEUTICALS]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ESCITALOPRAM TABLET [CAMBER PHARMACEUTICALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ESCITALOPRAM TABLET [CAMBER PHARMACEUTICALS]	1

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Escitalopram Oxalate	ESCITALOPRAM	REMEDYREPACK INC.	4508226c-5623-41d3-8916-5f94ffdb8839	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078604 application number: ANDA078604
Escitalopram Oxalate	ESCITALOPRAM	Legacy Pharmaceutical Packaging, LLC	9c68f89b-1d34-4735-9631-817f012935d7	2026-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078604 application number: ANDA078604
Escitalopram Oxalate	ESCITALOPRAM	Cipla USA Inc.	31ce0b82-58fe-44f3-8887-c55d8df1b773	2025-10-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078604 application number: ANDA078604
Escitalopram oxalate	ESCITALOPRAM	Exelan Pharmaceuticals Inc.	8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd2	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078604 application number: ANDA078604
Escitalopram oxalate	ESCITALOPRAM	Aphena Pharma Solutions - Tennessee, LLC	900b7a2f-23e7-4c78-bd6e-549bbe09883e	2021-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078604 application number: ANDA078604

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5U85DBW7LO	ESCITALOPRAM OXALATE	219861-08-2	ESCITALOPRAM OXALATE
4O4S742ANY	ESCITALOPRAM	128196-01-0	Escitalopram

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Escitalopram	Camber Pharmaceuticals \| Invagen Pharmaceuticals	2012-09-13	HUMAN PRESCRIPTION DRUG LABEL	1