Escitalopram

Product NDC: 50090-3331
Requested package NDC: 50090-3331-0
11-digit product format: 500903331
Labeler code: 50090
Product ID: 50090-3331_b314da5b-2cc7-4161-b60d-9db5d97ad2b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Escitalopram
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA076765
Marketing category: ANDA
Marketing start: 2012-03-14
Marketing end: 0000-00-00
Substance: ESCITALOPRAM OXALATE
Active strength: 20 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-3331	50090-3331-0	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 1 · 17 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2020-12-18 03:04 UTC · source 2020-12-17	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	`9bebd1f3094a…`	`5416666fcb17…`

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	Approval date
A076765-001	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-03-14
A076765-002	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-03-14
A076765-003	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-03-14

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076765-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076765-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076765-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-03-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076765-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076765-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076765-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-03-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076765-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076765-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076765-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-03-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076765-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076765-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076765-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-03-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076765-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076765-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076765-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-03-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076765-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076765-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076765-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-03-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076765-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076765-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076765-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-03-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076765-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076765-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076765-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-03-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076765-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-03-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076765-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-03-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076765-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-03-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076765-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-03-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076765-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-03-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076765-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-03-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076765-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-03-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076765-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-03-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076765-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-03-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076765-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-03-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076765-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-03-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076765-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-03-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076765-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-03-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076765-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-03-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076765-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-03-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076765-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-03-14	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076765-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076765-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076765-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076765-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076765-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076765-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076765-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076765-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076765-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076765-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076765-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076765-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076765-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076765-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076765-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076765-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076765-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076765-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076765-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076765-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076765-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076765-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076765-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076765-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076765-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076765-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076765-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076765-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076765-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076765-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076765-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076765-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076765-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076765-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076765-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076765-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076765-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076765-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076765-003	AB	1	`ea99ee380514…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076765-001	AB	1	`3a93d1ddd44b…`

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, Effective, Related label table
NDC	Effective	Related label
50090-3331-0	2023-01-30	These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
50090-3331-1	2023-01-30	These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
50090-3331-0	2021-03-01	These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
50090-3331-1	2021-03-01	These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
50090-3331-0	2020-01-31	These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
50090-3331-1	2020-01-31	These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-3331-0	Escitalopram	30 in 1 BOTTLE	TABLET, FILM COATED	30		6
50090-3331-1	Escitalopram	90 in 1 BOTTLE	TABLET, FILM COATED	90		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-3331-0	EA - Each	50090-3331	0fa41d9a-62af-4dce-bce7-99eb59bae9ab	1	2019-05-02
50090-3331-1	EA - Each	50090-3331	20aa9558-b51f-415a-885a-d9709bc2d8aa	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3331	ESCITALOPRAM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	6	Legacy NDC, 2 package rows	20210303_88d77d84-7349-4af4-81ca-d5fd5099b7c7.zip

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
351250	escitalopram oxalate 20 MG Oral Tablet	PSN	88d77d84-7349-4af4-81ca-d5fd5099b7c7	6
351250	escitalopram 20 MG Oral Tablet	SCD	88d77d84-7349-4af4-81ca-d5fd5099b7c7	6
351250	escitalopram (as escitalopram oxalate) 20 MG Oral Tablet	SY	88d77d84-7349-4af4-81ca-d5fd5099b7c7	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3331-0	50090333100	30 TABLET, FILM COATED in 1 BOTTLE (50090-3331-0)	2018-01-15	0000-00-00	No	No	Current