Escitalopram

Product NDC: 0143-9808
11-digit product format: 001439808
Labeler code: 0143
Product ID: 0143-9808_322655e3-fff3-4292-abf5-fb9634227072
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Escitalopram
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: West-Ward Pharmaceuticals Corp
Application: ANDA078766
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0143-9808		D	Discontinued by firm	2026-08-07
excluded package	package	0143-9808	0143-9808-01	D	Discontinued by firm	2026-08-07
excluded package	package	0143-9808	0143-9808-05	D	Discontinued by firm	2026-08-07

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 · 36 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	0143-9808-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0143-9808-05	`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	0143-9808-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0143-9808-05	`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	0143-9808-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0143-9808-05	`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	0143-9808-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0143-9808-05	`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	0143-9808-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0143-9808-05	`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	0143-9808-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0143-9808-05	`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	0143-9808-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0143-9808-05	`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	0143-9808-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0143-9808-05	`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	0143-9808-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0143-9808-05	`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	0143-9808-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0143-9808-05	`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	0143-9808-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0143-9808-05	`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	0143-9808-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0143-9808-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	Approval date
A078766-001	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11
A078766-002	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11
A078766-003	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078766-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	2012-09-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078766-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	2012-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078766-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	2012-09-11	`8072bd15b7f6…`

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	A078766-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078766-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078766-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A078766-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078766-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078766-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078766-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078766-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078766-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078766-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078766-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078766-003	AB	1	`ea99ee380514…`

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9808-01	EA - Each	0143-9808	16128bad-952d-4b50-a283-f15373e664ce	1	2013-02-13
0143-9808-05	EA - Each	0143-9808	966f5dec-6cd5-4a57-90fa-a9360189c864	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, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
ESCITALOPRAM	ACTIVE MOIETY	4O4S742ANY	ESCITALOPRAM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ESCITALOPRAM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ESCITALOPRAM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	ESCITALOPRAM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESCITALOPRAM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
POLYETHYLENE GLYCOL 300	INACTIVE INGREDIENT	5655G9Y8AQ	ESCITALOPRAM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ESCITALOPRAM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ESCITALOPRAM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ESCITALOPRAM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1

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	30dc3720-cb57-45dd-bcaa-b92765ceb372	1
349332	escitalopram 10 MG Oral Tablet	SCD	30dc3720-cb57-45dd-bcaa-b92765ceb372	1
349332	escitalopram (as escitalopram oxalate) 10 MG Oral Tablet	SY	30dc3720-cb57-45dd-bcaa-b92765ceb372	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Escitalopram	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-04-08	HUMAN PRESCRIPTION DRUG LABEL	1