Escitalopram

Product NDC: 71335-1571
Requested package NDC: 71335-1571-2
11-digit product format: 713351571
Labeler code: 71335
Product ID: 71335-1571_c6523723-999b-481e-a9d7-8610a4d30ccb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Escitalopram
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078032
Marketing category: ANDA
Marketing start: 2012-03-15
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: No
Listing certified through: 2023-12-31
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	71335-1571	71335-1571-2	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 1 · 15 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…`

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
A078032-001	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-08-28
A078032-002	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-08-28
A078032-003	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2015-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078032-001	AB
A078032-002	AB
A078032-003	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	A078032-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078032-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078032-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2015-08-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078032-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078032-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078032-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2015-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078032-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078032-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078032-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2015-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078032-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078032-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078032-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2015-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078032-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078032-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078032-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2015-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078032-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078032-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078032-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2015-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078032-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078032-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078032-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2015-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078032-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078032-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078032-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2015-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078032-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078032-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078032-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2015-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078032-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078032-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078032-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2015-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078032-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078032-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078032-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2015-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078032-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-08-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078032-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-08-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078032-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2015-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078032-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-08-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078032-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-08-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078032-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2015-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078032-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-08-28	`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	A078032-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078032-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078032-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078032-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078032-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078032-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078032-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078032-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078032-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078032-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078032-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078032-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078032-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078032-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078032-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078032-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078032-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078032-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078032-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078032-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078032-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078032-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078032-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078032-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078032-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078032-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078032-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078032-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078032-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078032-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078032-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078032-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078032-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078032-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078032-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078032-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078032-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078032-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078032-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078032-001	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
71335-1571-1	These highlights do not include all the information needed to use ESCITALOPRAM TABLETS, USP, USP safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS, USP, USP. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
71335-1571-2	These highlights do not include all the information needed to use ESCITALOPRAM TABLETS, USP, USP safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS, USP, USP. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
71335-1571-3	These highlights do not include all the information needed to use ESCITALOPRAM TABLETS, USP, USP safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS, USP, USP. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
71335-1571-4	These highlights do not include all the information needed to use ESCITALOPRAM TABLETS, USP, USP safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS, USP, USP. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
71335-1571-5	These highlights do not include all the information needed to use ESCITALOPRAM TABLETS, USP, USP safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS, USP, USP. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
71335-1571-6	These highlights do not include all the information needed to use ESCITALOPRAM TABLETS, USP, USP safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS, USP, USP. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
71335-1571-7	These highlights do not include all the information needed to use ESCITALOPRAM TABLETS, USP, USP safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS, USP, USP. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
71335-1571-8	These highlights do not include all the information needed to use ESCITALOPRAM TABLETS, USP, USP safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS, USP, USP. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-1571-1	Escitalopram	30 in 1 BOTTLE	TABLET, FILM COATED	30	9
71335-1571-2	Escitalopram	28 in 1 BOTTLE	TABLET, FILM COATED	28	9
71335-1571-3	Escitalopram	60 in 1 BOTTLE	TABLET, FILM COATED	60	9
71335-1571-4	Escitalopram	90 in 1 BOTTLE	TABLET, FILM COATED	90	9
71335-1571-5	Escitalopram	10 in 1 BOTTLE	TABLET, FILM COATED	10	9
71335-1571-6	Escitalopram	120 in 1 BOTTLE	TABLET, FILM COATED	120	9
71335-1571-7	Escitalopram	7 in 1 BOTTLE	TABLET, FILM COATED	7	9
71335-1571-8	Escitalopram	180 in 1 BOTTLE	TABLET, FILM COATED	180	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1571	ESCITALOPRAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	9	Legacy NDC, 8 package rows	20220211_d96efcdf-88ac-4153-9a38-4cd47e5bbb5b.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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Escitalopram	ESCITALOPRAM	Bryant Ranch Prepack	20281fe6-7db9-4b33-8418-b25e6a5404ca	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
Escitalopram	ESCITALOPRAM	BluePoint Laboratories	d31c02d0-81d9-4aa4-bde9-52135aa5a66d	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
Escitalopram	ESCITALOPRAM	REMEDYREPACK INC.	83fb7392-087d-4284-b27b-fa192e49dc21	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
Escitalopram	ESCITALOPRAM	REMEDYREPACK INC.	b6fbd554-9da7-40fd-87a5-2c4af2aa3e6c	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
Escitalopram	ESCITALOPRAM	REMEDYREPACK INC.	83a642b9-acee-45d3-95a1-52a491b770fd	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
Escitalopram	ESCITALOPRAM	SOLCO HEALTHCARE US, LLC	155e973a-f4ff-4e5a-b937-09f1e106fe39	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
Escitalopram	ESCITALOPRAM	Coupler LLC	5088d6cd-ec13-384d-e063-6394a90aee05	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
Escitalopram	ESCITALOPRAM	Preferred Pharmaceuticals, Inc.	3e3a3e36-fb2f-4d9b-bbcf-423bd97c9f88	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
Escitalopram	ESCITALOPRAM	Direct_Rx	f435d670-87ff-f226-e053-2a95a90ac0ee	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
Escitalopram	ESCITALOPRAM	A-S Medication Solutions	ba6a0c20-4915-4164-a39e-ca67d652cbfd	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
Escitalopram	ESCITALOPRAM	A-S Medication Solutions	a0344290-6e12-46c4-a11c-5347a770adbe	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
Escitalopram	ESCITALOPRAM	REMEDYREPACK INC.	0ef807d2-5d66-40c2-be3e-ff6176a35295	2026-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
Escitalopram	ESCITALOPRAM	Northwind Health Company, LLC	f2b3b385-658d-5918-e053-2a95a90afcba	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
Escitalopram	ESCITALOPRAM	Northwind Health Company, LLC	f2b7b0a6-481b-1f6f-e053-2a95a90a2d04	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
Escitalopram	ESCITALOPRAM	Northwind Health Company, LLC	addccf96-cc60-6045-e053-2a95a90aaac0	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
Escitalopram	ESCITALOPRAM	Direct_Rx	f81e3858-f01e-1df6-e053-6394a90aef4f	2025-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
Escitalopram	ESCITALOPRAM	QPharma, Inc.	e56e8d41-188c-5a6f-e053-2a95a90a70e6	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
Escitalopram	ESCITALOPRAM	QPharma, Inc.	f682f991-1807-176a-e053-2995a90a3dfa	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
Escitalopram	ESCITALOPRAM	American Health Packaging	de803217-6d32-4ef8-afe7-02462f37bf0c	2025-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
Escitalopram	ESCITALOPRAM	RedPharm Drug, Inc.	fc61822a-4058-343c-e053-6294a90af72c	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032

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	d96efcdf-88ac-4153-9a38-4cd47e5bbb5b	9
349332	escitalopram 10 MG Oral Tablet	SCD	d96efcdf-88ac-4153-9a38-4cd47e5bbb5b	9
349332	escitalopram (as escitalopram oxalate) 10 MG Oral Tablet	SY	d96efcdf-88ac-4153-9a38-4cd47e5bbb5b	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1571-2	71335157102	28 TABLET, FILM COATED in 1 BOTTLE (71335-1571-2)	2022-02-10	0000-00-00	No	No	Current