Escitalopram

Product NDC: 51655-147
Requested package NDC: 51655-147-26
11-digit product format: 516550147
Labeler code: 51655
Product ID: 51655-147_48c3e3f2-09c4-c403-e063-6294a90aafde
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Escitalopram Oxalate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA090432
Marketing category: ANDA
Marketing start: 2023-01-25
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: 2027-12-31
Current FDA listing: Yes

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
A090432-001	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11
A090432-002	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11
A090432-003	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
A090432-001	AB
A090432-002	AB
A090432-003	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A090432-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090432-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090432-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A090432-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090432-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090432-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Escitalopram	ESCITALOPRAM OXALATE	PD-Rx Pharmaceuticals, Inc.	517a551a-6f60-4b8d-9341-63a41baff12d	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090432 application number: ANDA090432
Escitalopram	ESCITALOPRAM OXALATE	Bryant Ranch Prepack	ee5963ad-3b53-48e5-b7a9-b13af5740ef1	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090432 application number: ANDA090432
Escitalopram	ESCITALOPRAM OXALATE	St. Mary's Medical Park Pharmacy	09945404-e4cf-6269-e063-6294a90a5b8d	2026-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090432 application number: ANDA090432
Escitalopram	ESCITALOPRAM OXALATE	Aurobindo Pharma Limited	d5fbc8ce-bd41-4bd0-b413-0dea97e596c3	2026-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090432 application number: ANDA090432
Escitalopram	ESCITALOPRAM OXALATE	Asclemed USA, Inc.	2957a003-7714-4e16-aeca-623fd6c5d702	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090432 application number: ANDA090432
Escitalopram	ESCITALOPRAM OXALATE	Northwind Health Company, LLC	f6ca64ec-68ff-e1ea-e053-6294a90ae0f8	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090432 application number: ANDA090432 ndc (package): 51655-147-26 ndc (product): 51655-147 ndc11 (package): 51655014726
Escitalopram	ESCITALOPRAM OXALATE	QPharma, Inc.	85fbcce8-a870-4f04-8a0e-a12e46eed3cf	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090432 application number: ANDA090432
Escitalopram	ESCITALOPRAM OXALATE	American Health Packaging	3019a647-9bcf-48cf-928c-0467f9b921a8	2025-03-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090432 application number: ANDA090432
Escitalopram	ESCITALOPRAM OXALATE	NCS HealthCare of KY, LLC dba Vangard Labs	b29ae169-d60b-464a-9763-f1d8d9e0598d	2025-01-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090432 application number: ANDA090432
Escitalopram	ESCITALOPRAM OXALATE	A-S Medication Solutions	b85ef018-0217-4ddf-885d-206acc0a5f84	2024-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090432 application number: ANDA090432
Escitalopram	ESCITALOPRAM OXALATE	Advanced Rx Pharmacy of Tennessee, LLC	138f8703-2f13-6d07-e063-6394a90a4413	2024-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090432 application number: ANDA090432
Escitalopram	ESCITALOPRAM OXALATE	NCS HealthCare of KY, LLC dba Vangard Labs	ac9ede0c-7912-4e7d-83b3-964feee61215	2023-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090432 application number: ANDA090432
Escitalopram	ESCITALOPRAM OXALATE	A-S Medication Solutions	10b25a10-c5e7-479b-a9f5-7eeafd802323	2023-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090432 application number: ANDA090432
Escitalopram	ESCITALOPRAM OXALATE	Proficient Rx LP	52df055d-b1c8-4de2-8545-ef08b5bf9c39	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090432 application number: ANDA090432
Escitalopram	ESCITALOPRAM OXALATE	Proficient Rx LP	2d0b4839-e4d1-4e0e-9dc0-ba821f266472	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090432 application number: ANDA090432

Additional Listing Data#

Finished product: Yes
Brand name base: Escitalopram
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESCITALOPRAM OXALATE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5U85DBW7LO	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
351250	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f6ca64ec-68ff-e1ea-e053-6294a90ae0f8	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51655-147-26	Escitalopram	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-147	ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]	3	Current NDC, 1 package rows	20241215_f6ca64ec-68ff-e1ea-e053-6294a90ae0f8.zip

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
351250	escitalopram oxalate 20 MG Oral Tablet	PSN	f6ca64ec-68ff-e1ea-e053-6294a90ae0f8	4
351250	escitalopram 20 MG Oral Tablet	SCD	f6ca64ec-68ff-e1ea-e053-6294a90ae0f8	4
351250	escitalopram (as escitalopram oxalate) 20 MG Oral Tablet	SY	f6ca64ec-68ff-e1ea-e053-6294a90ae0f8	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
51655-147-26	51655014726	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-147-26)	2023-01-25	No	No	Current