Escitalopram

Product NDC: 53217-167
11-digit product format: 532170167
Labeler code: 53217
Product ID: 53217-167_4886349c-74c3-4fb0-a717-2296020cafe9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Escitalopram
Dosage form: TABLET
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA078604
Marketing category: ANDA
Marketing start: 2012-09-11
Marketing end: 0000-00-00
Substance: ESCITALOPRAM OXALATE
Active strength: 10 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53217-167		I	Inactivated by FDA	2026-08-17
excluded package	package	53217-167	53217-167-30	I	Inactivated by FDA	2026-08-17
excluded package	package	53217-167	53217-167-55	I	Inactivated by FDA	2026-08-17
excluded package	package	53217-167	53217-167-60	I	Inactivated by FDA	2026-08-17
excluded package	package	53217-167	53217-167-90	I	Inactivated by FDA	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 2 · 110 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	53217-167-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-167-55	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-167-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-167-30	`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	53217-167-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-167-55	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-167-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-167-30	`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	53217-167-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-167-55	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-167-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-167-30	`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	53217-167-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-167-55	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-167-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-167-30	`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	53217-167-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-167-55	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-167-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-167-30	`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	53217-167-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-167-55	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-167-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-167-30	`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	53217-167-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-167-55	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-167-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-167-30	`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	53217-167-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53217-167-55	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53217-167-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53217-167-30	`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	53217-167-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53217-167-55	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53217-167-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53217-167-30	`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	53217-167-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53217-167-55	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53217-167-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53217-167-30	`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	53217-167-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53217-167-55	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53217-167-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53217-167-30	`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	53217-167-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53217-167-55	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53217-167-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53217-167-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615	Product name	6	20170718

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
53217-167-30	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
53217-167-55	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
53217-167-60	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
53217-167-90	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53217-167-30	Escitalopram	30 in 1 BOTTLE	TABLET	30	1
53217-167-55	Escitalopram	500 in 1 BOTTLE	TABLET	500	1
53217-167-60	Escitalopram	60 in 1 BOTTLE	TABLET	60	1
53217-167-90	Escitalopram	90 in 1 BOTTLE	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53217-167-30	EA - Each	53217-167	abca4330-5e36-4537-a51f-ddfe3539324c	1	2017-03-06
53217-167-55	EA - Each	53217-167	91d2bca6-e9e3-406e-869b-b496f56dbbd8	1	2017-03-06
53217-167-60	EA - Each	53217-167	6ab40786-5304-49ed-879d-972cd38470e1	1	2017-03-06
53217-167-90	EA - Each	53217-167	470c05c0-a296-4378-a35f-bf017386c09a	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-167	ESCITALOPRAM TABLET [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 4 package rows	20170223_dbd3fe4f-75c9-4d1c-85c3-5466ca785283.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349332	escitalopram oxalate 10 MG Oral Tablet	PSN	dbd3fe4f-75c9-4d1c-85c3-5466ca785283	1
349332	escitalopram 10 MG Oral Tablet	SCD	dbd3fe4f-75c9-4d1c-85c3-5466ca785283	1
349332	escitalopram (as escitalopram oxalate) 10 MG Oral Tablet	SY	dbd3fe4f-75c9-4d1c-85c3-5466ca785283	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-167-30	53217016730	30 in 1 BOTTLE	Historical
53217-167-55	53217016755	500 in 1 BOTTLE	Historical
53217-167-60	53217016760	60 in 1 BOTTLE	Historical
53217-167-90	53217016790	90 in 1 BOTTLE	Historical