Escitalopram

Product NDC: 43547-280
11-digit product format: 435470280
Labeler code: 43547
Product ID: 43547-280_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: 5 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 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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESCITALOPRAM OXALATE	5 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
43547-280-10	Escitalopram	100 in 1 BOTTLE	TABLET, FILM COATED	100		18
43547-280-11	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
43547-280-10	EA - Each	43547-280	3e6f0b4a-4379-4e62-8582-ff412451b988	1	2016-03-04
43547-280-11	EA - Each	43547-280	647cce0c-db1a-4809-98c6-1b0cf542b1a0	1	2016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43547-280	ESCITALOPRAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	14	Current NDC, Legacy NDC, 2 package rows	20240831_155e973a-f4ff-4e5a-b937-09f1e106fe39.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 ndc (product): 43547-280
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
351249	escitalopram oxalate 5 MG Oral Tablet	PSN	20281fe6-7db9-4b33-8418-b25e6a5404ca	103
351249	escitalopram 5 MG Oral Tablet	SCD	20281fe6-7db9-4b33-8418-b25e6a5404ca	103
351249	escitalopram (as escitalopram oxalate) 5 MG Oral Tablet	SY	20281fe6-7db9-4b33-8418-b25e6a5404ca	103
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
351249	escitalopram oxalate 5 MG Oral Tablet	PSN	83a642b9-acee-45d3-95a1-52a491b770fd	14
351249	escitalopram 5 MG Oral Tablet	SCD	83a642b9-acee-45d3-95a1-52a491b770fd	14
351249	escitalopram (as escitalopram oxalate) 5 MG Oral Tablet	SY	83a642b9-acee-45d3-95a1-52a491b770fd	14
351249	escitalopram oxalate 5 MG Oral Tablet	PSN	b9453a53-93ac-b103-e053-2995a90a18ff	7
351249	escitalopram 5 MG Oral Tablet	SCD	b9453a53-93ac-b103-e053-2995a90a18ff	7
351249	escitalopram (as escitalopram oxalate) 5 MG Oral Tablet	SY	b9453a53-93ac-b103-e053-2995a90a18ff	7
351249	escitalopram oxalate 5 MG Oral Tablet	PSN	9b0b3c54-5bbc-4db9-9c69-00dac1347f24	5
351249	escitalopram oxalate 5 MG Oral Tablet	PSN	f2b3b385-658d-5918-e053-2a95a90afcba	5
351249	escitalopram 5 MG Oral Tablet	SCD	9b0b3c54-5bbc-4db9-9c69-00dac1347f24	5
351249	escitalopram 5 MG Oral Tablet	SCD	f2b3b385-658d-5918-e053-2a95a90afcba	5
351249	escitalopram (as escitalopram oxalate) 5 MG Oral Tablet	SY	9b0b3c54-5bbc-4db9-9c69-00dac1347f24	5
351249	escitalopram (as escitalopram oxalate) 5 MG Oral Tablet	SY	f2b3b385-658d-5918-e053-2a95a90afcba	5
351249	escitalopram oxalate 5 MG Oral Tablet	PSN	f75aabf8-f4a1-acd1-e053-6294a90ab9a6	2
351249	escitalopram 5 MG Oral Tablet	SCD	f75aabf8-f4a1-acd1-e053-6294a90ab9a6	2
351249	escitalopram (as escitalopram oxalate) 5 MG Oral Tablet	SY	f75aabf8-f4a1-acd1-e053-6294a90ab9a6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43547-280-10	43547028010	100 TABLET, FILM COATED in 1 BOTTLE (43547-280-10)	2016-02-01	0000-00-00	No	No	Current
43547-280-11	43547028011	1000 TABLET, FILM COATED in 1 BOTTLE (43547-280-11)	2016-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Escitalopram	Bryant Ranch Prepack	2026-06-30	HUMAN PRESCRIPTION DRUG LABEL	104
Escitalopram	REMEDYREPACK INC.	2026-05-21	HUMAN PRESCRIPTION DRUG LABEL	14
Escitalopram	SOLCO HEALTHCARE US, LLC	2026-05-20	HUMAN PRESCRIPTION DRUG LABEL	18
Escitalopram	Northwind Health Company, LLC	2026-01-19	HUMAN PRESCRIPTION DRUG LABEL	5
Escitalopram	REMEDYREPACK INC.	2025-08-29	HUMAN PRESCRIPTION DRUG LABEL	9
Escitalopram	Direct_Rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	2
ESCITALOPRAM 5mg tablets	RedPharm Drug, Inc. \| RedPharm Drug	2024-08-07	HUMAN PRESCRIPTION DRUG LABEL	7
Escitalopram	A-S Medication Solutions	2023-07-24	HUMAN PRESCRIPTION DRUG LABEL	5
Escitalopram	Preferred Pharmaceuticals, Inc.	2022-05-11	HUMAN PRESCRIPTION DRUG LABEL	4
Escitalopram	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2020-07-16	HUMAN PRESCRIPTION DRUG LABEL	1