escitalopram

Product NDC: 13668-135
11-digit product format: 136680135
Labeler code: 13668
Product ID: 13668-135_aa1ecae7-8a57-434f-a72b-088335b1a42c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: escitalopram
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Torrent Pharmaceuticals Limited
Application: ANDA090939
Marketing category: ANDA
Marketing start: 2012-09-11
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 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…`

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
068bb338-23f3-4278-958b-c34b40456024	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	SPL version
13668-135-01	escitalopram	100 in 1 BOTTLE	TABLET, FILM COATED	100	28
13668-135-05	escitalopram	500 in 1 BOTTLE	TABLET, FILM COATED	500	28
13668-135-10	escitalopram	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	28
13668-135-30	escitalopram	30 in 1 BOTTLE	TABLET, FILM COATED	30	28
13668-135-40	escitalopram	4000 in 1 BOTTLE	TABLET, FILM COATED	4000	28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-135-01	EA - Each	13668-135	f24046e3-d2ee-4d24-8948-72aa927fc4fd	1	2013-02-13
13668-135-05	EA - Each	13668-135	42888c1a-fb4a-4861-9588-e356fcf05362	1	2013-02-13
13668-135-10	EA - Each	13668-135	0aa4b532-59e9-4a2c-aa7d-289a1a18333d	1	2013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESCITALOPRAM OXALATE	ACTIVE INGREDIENT	5U85DBW7LO	ESCITALOPRAM OXALATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	7
ESCITALOPRAM	ACTIVE MOIETY	4O4S742ANY	ESCITALOPRAM OXALATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ESCITALOPRAM OXALATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	7
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ESCITALOPRAM OXALATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ESCITALOPRAM OXALATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	7
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	ESCITALOPRAM OXALATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESCITALOPRAM OXALATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	7
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ESCITALOPRAM OXALATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	7
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ESCITALOPRAM OXALATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ESCITALOPRAM OXALATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ESCITALOPRAM OXALATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	7
ESCITALOPRAM OXALATE	ACTIVE INGREDIENT	5U85DBW7LO	ESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]	1
ESCITALOPRAM	ACTIVE MOIETY	4O4S742ANY	ESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	ESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ESCITALOPRAM OXALATE TABLET [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13668-135	ESCITALOPRAM TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]	27	Current NDC, Legacy NDC, 5 package rows	20250125_068bb338-23f3-4278-958b-c34b40456024.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 ndc (product): 13668-135
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
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	a0ff752d-cb30-4131-a7d6-cd66d8a47b1a	105
351249	escitalopram 5 MG Oral Tablet	SCD	a0ff752d-cb30-4131-a7d6-cd66d8a47b1a	105
351249	escitalopram (as escitalopram oxalate) 5 MG Oral Tablet	SY	a0ff752d-cb30-4131-a7d6-cd66d8a47b1a	105
349332	escitalopram oxalate 10 MG Oral Tablet	PSN	068bb338-23f3-4278-958b-c34b40456024	28
351250	escitalopram oxalate 20 MG Oral Tablet	PSN	068bb338-23f3-4278-958b-c34b40456024	28
351249	escitalopram oxalate 5 MG Oral Tablet	PSN	068bb338-23f3-4278-958b-c34b40456024	28
349332	escitalopram 10 MG Oral Tablet	SCD	068bb338-23f3-4278-958b-c34b40456024	28
351250	escitalopram 20 MG Oral Tablet	SCD	068bb338-23f3-4278-958b-c34b40456024	28
351249	escitalopram 5 MG Oral Tablet	SCD	068bb338-23f3-4278-958b-c34b40456024	28
349332	escitalopram (as escitalopram oxalate) 10 MG Oral Tablet	SY	068bb338-23f3-4278-958b-c34b40456024	28
351250	escitalopram (as escitalopram oxalate) 20 MG Oral Tablet	SY	068bb338-23f3-4278-958b-c34b40456024	28
351249	escitalopram (as escitalopram oxalate) 5 MG Oral Tablet	SY	068bb338-23f3-4278-958b-c34b40456024	28
351249	escitalopram oxalate 5 MG Oral Tablet	PSN	e773030f-d07d-4bb8-9dc9-6f649688346d	3
351249	escitalopram 5 MG Oral Tablet	SCD	e773030f-d07d-4bb8-9dc9-6f649688346d	3
351249	escitalopram (as escitalopram oxalate) 5 MG Oral Tablet	SY	e773030f-d07d-4bb8-9dc9-6f649688346d	3
351249	escitalopram oxalate 5 MG Oral Tablet	PSN	5cc83a3e-46bc-3b58-e053-2a91aa0a3382	2
351249	escitalopram 5 MG Oral Tablet	SCD	5cc83a3e-46bc-3b58-e053-2a91aa0a3382	2
351249	escitalopram (as escitalopram oxalate) 5 MG Oral Tablet	SY	5cc83a3e-46bc-3b58-e053-2a91aa0a3382	2
349332	escitalopram oxalate 10 MG Oral Tablet	PSN	ec5c6a1e-a9e8-4b74-8175-960063bcd1a2	1
351250	escitalopram oxalate 20 MG Oral Tablet	PSN	ec5c6a1e-a9e8-4b74-8175-960063bcd1a2	1
351249	escitalopram oxalate 5 MG Oral Tablet	PSN	54c98db4-3430-4423-afce-1262810336ae	1
351249	escitalopram oxalate 5 MG Oral Tablet	PSN	ec5c6a1e-a9e8-4b74-8175-960063bcd1a2	1
349332	escitalopram 10 MG Oral Tablet	SCD	ec5c6a1e-a9e8-4b74-8175-960063bcd1a2	1
351250	escitalopram 20 MG Oral Tablet	SCD	ec5c6a1e-a9e8-4b74-8175-960063bcd1a2	1
351249	escitalopram 5 MG Oral Tablet	SCD	54c98db4-3430-4423-afce-1262810336ae	1
351249	escitalopram 5 MG Oral Tablet	SCD	ec5c6a1e-a9e8-4b74-8175-960063bcd1a2	1
349332	escitalopram (as escitalopram oxalate) 10 MG Oral Tablet	SY	ec5c6a1e-a9e8-4b74-8175-960063bcd1a2	1
351250	escitalopram (as escitalopram oxalate) 20 MG Oral Tablet	SY	ec5c6a1e-a9e8-4b74-8175-960063bcd1a2	1
351249	escitalopram (as escitalopram oxalate) 5 MG Oral Tablet	SY	ec5c6a1e-a9e8-4b74-8175-960063bcd1a2	1
351249	escitalopram (as escitalopram oxalate) 5 MG Oral Tablet	SY	54c98db4-3430-4423-afce-1262810336ae	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13668-135-01	13668013501	100 TABLET, FILM COATED in 1 BOTTLE (13668-135-01)		2012-09-11	0000-00-00	No	No	Current
13668-135-05	13668013505	500 TABLET, FILM COATED in 1 BOTTLE (13668-135-05)		2012-09-11	0000-00-00	No	No	Current
13668-135-10	13668013510	1000 TABLET, FILM COATED in 1 BOTTLE (13668-135-10)		2012-09-11	0000-00-00	No	No	Current
13668-135-30	13668013530	30 TABLET, FILM COATED in 1 BOTTLE (13668-135-30)		2012-09-11	0000-00-00	No	No	Current
13668-135-40	13668013540	4000 TABLET, FILM COATED in 1 BOTTLE (13668-135-40)		2012-09-11	0000-00-00	No	No	Current
13668-135-74	13668013574	100 TABLET in 1 CARTON (13668-135-74)	100 tablet	2012-09-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
escitalopram	Bryant Ranch Prepack	2026-03-19	HUMAN PRESCRIPTION DRUG LABEL	105
escitalopram	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc. \| VKT Pharma Private Limited	2026-02-06	HUMAN PRESCRIPTION DRUG LABEL	28
escitalopram oxalate	REMEDYREPACK INC.	2023-04-14	HUMAN PRESCRIPTION DRUG LABEL	9
escitalopram oxalate	Quality Care Products, LLC	2023-02-14	HUMAN PRESCRIPTION DRUG LABEL	1
escitalopram oxalate	A-S Medication Solutions	2021-01-14	HUMAN PRESCRIPTION DRUG LABEL	1
escitalopram oxalate	Proficient Rx LP	2020-03-01	HUMAN PRESCRIPTION DRUG LABEL	3
ESCITALOPRAM 5mg	DIRECT RX	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	2
escitalopram oxalate	REMEDYREPACK INC.	2019-03-28	HUMAN PRESCRIPTION DRUG LABEL	3
escitalopram oxalate	NuCare Pharmaceuticals,Inc.	2018-01-04	HUMAN PRESCRIPTION DRUG LABEL	1
escitalopram oxalate	Blenheim Pharmacal, Inc.	2015-02-12	HUMAN PRESCRIPTION DRUG LABEL	1