Escitalopram

Product NDC: 43547-282
11-digit product format: 435470282
Labeler code: 43547
Product ID: 43547-282_9eb8b7e7-53d7-461e-86e5-670262dad840
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Escitalopram
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: SOLCO HEALTHCARE US, LLC
Application: ANDA078032
Marketing category: ANDA
Marketing start: 2016-02-01
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
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.

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	A078032-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-08-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078032-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-08-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078032-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2015-08-28	`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	A078032-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078032-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078032-003	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 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 ndc (product): 43547-282
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

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349332	Internal RxNorm lookup
351249	Internal RxNorm lookup
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
155e973a-f4ff-4e5a-b937-09f1e106fe39	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
43547-282-10	Escitalopram	100 in 1 BOTTLE	TABLET, FILM COATED	100		18
43547-282-11	Escitalopram	1000 in 1 BOTTLE	TABLET, FILM COATED	1000		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43547-282-10	EA - Each	43547-282	42737665-ee3b-4ea7-b28d-d97c06aad683	1	2016-04-04
43547-282-11	EA - Each	43547-282	5e708acc-645d-4ca9-b495-45153981fea9	1	2016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43547-282	ESCITALOPRAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	14	Current NDC, Legacy NDC, 2 package rows	20240831_155e973a-f4ff-4e5a-b937-09f1e106fe39.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	102c3893-4fdc-40b3-bd83-775e292723d7	104
351250	escitalopram 20 MG Oral Tablet	SCD	102c3893-4fdc-40b3-bd83-775e292723d7	104
351250	escitalopram (as escitalopram oxalate) 20 MG Oral Tablet	SY	102c3893-4fdc-40b3-bd83-775e292723d7	104
349332	escitalopram oxalate 10 MG Oral Tablet	PSN	155e973a-f4ff-4e5a-b937-09f1e106fe39	18
351250	escitalopram oxalate 20 MG Oral Tablet	PSN	155e973a-f4ff-4e5a-b937-09f1e106fe39	18
351249	escitalopram oxalate 5 MG Oral Tablet	PSN	155e973a-f4ff-4e5a-b937-09f1e106fe39	18
349332	escitalopram 10 MG Oral Tablet	SCD	155e973a-f4ff-4e5a-b937-09f1e106fe39	18
351250	escitalopram 20 MG Oral Tablet	SCD	155e973a-f4ff-4e5a-b937-09f1e106fe39	18
351249	escitalopram 5 MG Oral Tablet	SCD	155e973a-f4ff-4e5a-b937-09f1e106fe39	18
349332	escitalopram (as escitalopram oxalate) 10 MG Oral Tablet	SY	155e973a-f4ff-4e5a-b937-09f1e106fe39	18
351250	escitalopram (as escitalopram oxalate) 20 MG Oral Tablet	SY	155e973a-f4ff-4e5a-b937-09f1e106fe39	18
351249	escitalopram (as escitalopram oxalate) 5 MG Oral Tablet	SY	155e973a-f4ff-4e5a-b937-09f1e106fe39	18
351250	escitalopram oxalate 20 MG Oral Tablet	PSN	3e3a3e36-fb2f-4d9b-bbcf-423bd97c9f88	7
351250	escitalopram oxalate 20 MG Oral Tablet	PSN	34d14a62-3bdd-405c-82e6-a03302b29860	7
351250	escitalopram 20 MG Oral Tablet	SCD	34d14a62-3bdd-405c-82e6-a03302b29860	7
351250	escitalopram 20 MG Oral Tablet	SCD	3e3a3e36-fb2f-4d9b-bbcf-423bd97c9f88	7
351250	escitalopram (as escitalopram oxalate) 20 MG Oral Tablet	SY	3e3a3e36-fb2f-4d9b-bbcf-423bd97c9f88	7
351250	escitalopram (as escitalopram oxalate) 20 MG Oral Tablet	SY	34d14a62-3bdd-405c-82e6-a03302b29860	7
351250	escitalopram oxalate 20 MG Oral Tablet	PSN	addccf96-cc60-6045-e053-2a95a90aaac0	6
351250	escitalopram 20 MG Oral Tablet	SCD	addccf96-cc60-6045-e053-2a95a90aaac0	6
351250	escitalopram (as escitalopram oxalate) 20 MG Oral Tablet	SY	addccf96-cc60-6045-e053-2a95a90aaac0	6
351250	escitalopram oxalate 20 MG Oral Tablet	PSN	a489600b-6ae0-edb7-e053-2a95a90a7d00	4
351250	escitalopram oxalate 20 MG Oral Tablet	PSN	575d7755-0518-4d48-bb1a-4ad01321fde7	4
351250	escitalopram oxalate 20 MG Oral Tablet	PSN	f682f991-1807-176a-e053-2995a90a3dfa	4
351250	escitalopram 20 MG Oral Tablet	SCD	575d7755-0518-4d48-bb1a-4ad01321fde7	4
351250	escitalopram 20 MG Oral Tablet	SCD	a489600b-6ae0-edb7-e053-2a95a90a7d00	4
351250	escitalopram 20 MG Oral Tablet	SCD	f682f991-1807-176a-e053-2995a90a3dfa	4
351250	escitalopram (as escitalopram oxalate) 20 MG Oral Tablet	SY	a489600b-6ae0-edb7-e053-2a95a90a7d00	4
351250	escitalopram (as escitalopram oxalate) 20 MG Oral Tablet	SY	f682f991-1807-176a-e053-2995a90a3dfa	4
351250	escitalopram (as escitalopram oxalate) 20 MG Oral Tablet	SY	575d7755-0518-4d48-bb1a-4ad01321fde7	4
351250	escitalopram oxalate 20 MG Oral Tablet	PSN	bb66252e-3a0f-7240-e053-2a95a90acfd9	3
351250	escitalopram oxalate 20 MG Oral Tablet	PSN	2ffc6ec3-830f-46bc-9b3f-7c42cefa39b2	3
351250	escitalopram oxalate 20 MG Oral Tablet	PSN	f81e3858-f01e-1df6-e053-6394a90aef4f	3
351250	escitalopram 20 MG Oral Tablet	SCD	2ffc6ec3-830f-46bc-9b3f-7c42cefa39b2	3
351250	escitalopram 20 MG Oral Tablet	SCD	bb66252e-3a0f-7240-e053-2a95a90acfd9	3
351250	escitalopram 20 MG Oral Tablet	SCD	f81e3858-f01e-1df6-e053-6394a90aef4f	3
351250	escitalopram (as escitalopram oxalate) 20 MG Oral Tablet	SY	bb66252e-3a0f-7240-e053-2a95a90acfd9	3
351250	escitalopram (as escitalopram oxalate) 20 MG Oral Tablet	SY	2ffc6ec3-830f-46bc-9b3f-7c42cefa39b2	3
351250	escitalopram (as escitalopram oxalate) 20 MG Oral Tablet	SY	f81e3858-f01e-1df6-e053-6394a90aef4f	3
351250	escitalopram oxalate 20 MG Oral Tablet	PSN	fc61822a-4058-343c-e053-6294a90af72c	2
351250	escitalopram oxalate 20 MG Oral Tablet	PSN	db93c6f1-d541-40eb-8836-702c952f4773	2
351250	escitalopram 20 MG Oral Tablet	SCD	fc61822a-4058-343c-e053-6294a90af72c	2
351250	escitalopram 20 MG Oral Tablet	SCD	db93c6f1-d541-40eb-8836-702c952f4773	2
351250	escitalopram (as escitalopram oxalate) 20 MG Oral Tablet	SY	fc61822a-4058-343c-e053-6294a90af72c	2
351250	escitalopram (as escitalopram oxalate) 20 MG Oral Tablet	SY	db93c6f1-d541-40eb-8836-702c952f4773	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43547-282-10	43547028210	100 TABLET, FILM COATED in 1 BOTTLE (43547-282-10)	2016-02-01	0000-00-00	No	No	Current
43547-282-11	43547028211	1000 TABLET, FILM COATED in 1 BOTTLE (43547-282-11)	2016-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Escitalopram	REMEDYREPACK INC.	2026-06-01	HUMAN PRESCRIPTION DRUG LABEL	17
Escitalopram	SOLCO HEALTHCARE US, LLC	2026-05-20	HUMAN PRESCRIPTION DRUG LABEL	18
Escitalopram	Preferred Pharmaceuticals, Inc.	2026-04-13	HUMAN PRESCRIPTION DRUG LABEL	7
Escitalopram	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	6
Escitalopram	Direct_Rx	2025-12-16	HUMAN PRESCRIPTION DRUG LABEL	3
Escitalopram	QPharma, Inc. \| Northwind Health Company, LLC	2025-12-01	HUMAN PRESCRIPTION DRUG LABEL	4
ESCITALOPRAM 20mg TABLETS	RedPharm Drug, Inc. \| Redpharm	2025-01-23	HUMAN PRESCRIPTION DRUG LABEL	2
Escitalopram	Quality Care Products, LLC	2024-12-18	HUMAN PRESCRIPTION DRUG LABEL	7
Escitalopram	St. Mary's Medical Park Pharmacy	2024-12-12	HUMAN PRESCRIPTION DRUG LABEL	2
Escitalopram	Bryant Ranch Prepack	2024-08-23	HUMAN PRESCRIPTION DRUG LABEL	104
Escitalopram	NuCare Pharmaceuticals,Inc.	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	4
Escitalopram	A-S Medication Solutions	2024-04-25	HUMAN PRESCRIPTION DRUG LABEL	3
Escitalopram	A-S Medication Solutions	2023-12-15	HUMAN PRESCRIPTION DRUG LABEL	4
Escitalopram	RPK Pharmaceuticals, Inc.	2023-09-11	HUMAN PRESCRIPTION DRUG LABEL	2
ESCITALOPRAM 20mg TABLETS	RedPharm Drug, Inc. \| EPM Packaging, Inc.	2021-02-15	HUMAN PRESCRIPTION DRUG LABEL	3
Escitalopram	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2020-07-16	HUMAN PRESCRIPTION DRUG LABEL	1