escitalopram oxalate

Product NDC: 68071-3265
Requested package NDC: 68071-3265-2
11-digit product format: 680713265
Labeler code: 68071
Product ID: 68071-3265_e11b27ab-5a2b-76c4-e053-2a95a90a7293
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: escitalopram oxalate
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA090939
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: 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	68071-3265	68071-3265-2	I	Inactivated by FDA		2026-08-03

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 · 11 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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	TE codes	Approval date
A090939-001	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11
A090939-002	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11
A090939-003	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
A090939-001	AB
A090939-002	AB
A090939-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A090939-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090939-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090939-003	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	A090939-001	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	A090939-002	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	A090939-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090939-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090939-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090939-003	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	A090939-001	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	A090939-002	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	A090939-003	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	A090939-001	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	A090939-002	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	A090939-003	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	A090939-001	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	A090939-002	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	A090939-003	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	A090939-001	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	A090939-002	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	A090939-003	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	A090939-001	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	A090939-002	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	A090939-003	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	A090939-001	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	A090939-002	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	A090939-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090939-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090939-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090939-003	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	A090939-001	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	A090939-002	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	A090939-003	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	A090939-001	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	A090939-002	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	A090939-003	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	A090939-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090939-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090939-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090939-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090939-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090939-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090939-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090939-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090939-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090939-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090939-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090939-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090939-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090939-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090939-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090939-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090939-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090939-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090939-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090939-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090939-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090939-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090939-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090939-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090939-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090939-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090939-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090939-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090939-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090939-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090939-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090939-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090939-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090939-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090939-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090939-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090939-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090939-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090939-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090939-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090939-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090939-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090939-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090939-001	AB	1	`8072bd15b7f6…`

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
68071-3265-2	2025-01-30	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 USP, for oral use Initial U.S. Approval: 2002
68071-3265-3	2025-01-30	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 USP, for oral use Initial U.S. Approval: 2002
68071-3265-9	2025-01-30	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 USP, for oral use Initial U.S. Approval: 2002
68071-3265-2	2020-07-21	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 USP, for oral use Initial U.S. Approval: 2002
68071-3265-3	2020-07-21	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 USP, for oral use Initial U.S. Approval: 2002
68071-3265-9	2020-07-21	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 USP, for oral use Initial U.S. Approval: 2002
68071-3265-2	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 USP, for oral use Initial U.S. Approval: 2002
68071-3265-3	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 USP, for oral use Initial U.S. Approval: 2002
68071-3265-9	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 USP, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-3265-2	escitalopram oxalate	20 in 1 BOTTLE	TABLET	20	4
68071-3265-3	escitalopram oxalate	30 in 1 BOTTLE	TABLET	30	4
68071-3265-9	escitalopram oxalate	90 in 1 BOTTLE	TABLET	90	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3265	ESCITALOPRAM OXALATE TABLET [NUCARE PHARMACEUTICALS, INC.]	4	Legacy NDC, 3 package rows	20220612_4f434cbc-318b-6554-e054-00144ff88e88.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
escitalopram	ESCITALOPRAM	Preferred Pharmaceuticals Inc.	9ddd1f24-3ebd-4307-bb23-6acd742cd140	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090939 application number: ANDA090939
escitalopram	ESCITALOPRAM	Bryant Ranch Prepack	1d2f83c1-8ffe-48f3-a084-150289001743	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090939 application number: ANDA090939
escitalopram	ESCITALOPRAM	Bryant Ranch Prepack	5c00c4d3-8248-4321-adec-03886c0d0f7b	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090939 application number: ANDA090939
escitalopram oxalate	ESCITALOPRAM OXALATE	Bryant Ranch Prepack	a3a158a3-43ee-4b08-8171-e8c0d6ed0e66	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090939 application number: ANDA090939
escitalopram	ESCITALOPRAM	Cardinal Health 107, LLC	cb3f9af4-5bb4-48a8-b972-ff92cff1ea01	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090939 application number: ANDA090939
escitalopram oxalate	ESCITALOPRAM OXALATE	Preferred Pharmaceuticals Inc.	7d924d16-8a10-411d-be57-97c450f56de7	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090939 application number: ANDA090939
escitalopram	ESCITALOPRAM	Bryant Ranch Prepack	a0ff752d-cb30-4131-a7d6-cd66d8a47b1a	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090939 application number: ANDA090939
escitalopram	ESCITALOPRAM	Bryant Ranch Prepack	cb30d1c5-2280-465f-84f4-4367ad5f1a31	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090939 application number: ANDA090939
escitalopram	ESCITALOPRAM	Bryant Ranch Prepack	0de88dad-d54c-4773-a5d6-a705e012973a	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090939 application number: ANDA090939
escitalopram	ESCITALOPRAM	Major Pharmaceuticals	f4a12048-181e-45ed-a382-f53096d1b689	2026-02-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090939 application number: ANDA090939
escitalopram	ESCITALOPRAM	Torrent Pharmaceuticals Limited	068bb338-23f3-4278-958b-c34b40456024	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090939 application number: ANDA090939
escitalopram oxalate	ESCITALOPRAM OXALATE	PD-Rx Pharmaceuticals, Inc.	b7670e51-8f44-4f64-b110-3f2f431a4032	2025-10-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090939 application number: ANDA090939
Escitalopram	ESCITALOPRAM	Direct_Rx	f6cacd68-0f55-deb9-e053-6294a90aa266	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090939 application number: ANDA090939
escitalopram oxalate	ESCITALOPRAM OXALATE	Bryant Ranch Prepack	86cfcd96-6397-42ef-8a79-f62706f0aca6	2024-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090939 application number: ANDA090939
escitalopram oxalate	ESCITALOPRAM OXALATE	Quallent Pharmaceuticals Health LLC	d8e22060-4d06-42bf-a881-caaf65ecc3e3	2024-10-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090939 application number: ANDA090939
escitalopram oxalate	ESCITALOPRAM OXALATE	Proficient Rx LP	8201a719-7837-45fb-b991-4fcdbf006d24	2023-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090939 application number: ANDA090939
escitalopram oxalate	ESCITALOPRAM OXALATE	Proficient Rx LP	e773030f-d07d-4bb8-9dc9-6f649688346d	2020-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090939 application number: ANDA090939

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5U85DBW7LO	ESCITALOPRAM OXALATE	219861-08-2	ESCITALOPRAM OXALATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349332	escitalopram oxalate 10 MG Oral Tablet	PSN	4f434cbc-318b-6554-e054-00144ff88e88	4
349332	escitalopram 10 MG Oral Tablet	SCD	4f434cbc-318b-6554-e054-00144ff88e88	4
349332	escitalopram (as escitalopram oxalate) 10 MG Oral Tablet	SY	4f434cbc-318b-6554-e054-00144ff88e88	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-3265-2	68071326502	20 TABLET in 1 BOTTLE (68071-3265-2)	20 tablet	2017-05-11	0000-00-00	No	No	Current