Escitalopram

Product NDC: 71335-1187
11-digit product format: 713351187
Labeler code: 71335
Product ID: 71335-1187_c93fa349-242e-4268-a6d5-0db5564cc181
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Escitalopram
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078032
Marketing category: ANDA
Marketing start: 2016-02-01
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 132 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
2026-10-15 13:18:30	2026-09	A078032-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-08-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078032-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-08-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078032-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2015-08-28	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078032-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2015-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078032-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2015-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078032-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2015-08-28	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A078032-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078032-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078032-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078032-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078032-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078032-003	AB	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Escitalopram
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESCITALOPRAM OXALATE	10 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
349332	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
c842ec12-8792-47a9-82ad-9edf99e549ba	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	SPL version
71335-1187-1	Escitalopram	30 in 1 BOTTLE	TABLET, FILM COATED	30	10
71335-1187-2	Escitalopram	28 in 1 BOTTLE	TABLET, FILM COATED	28	10
71335-1187-3	Escitalopram	60 in 1 BOTTLE	TABLET, FILM COATED	60	10
71335-1187-4	Escitalopram	90 in 1 BOTTLE	TABLET, FILM COATED	90	10
71335-1187-5	Escitalopram	10 in 1 BOTTLE	TABLET, FILM COATED	10	10
71335-1187-6	Escitalopram	120 in 1 BOTTLE	TABLET, FILM COATED	120	10
71335-1187-7	Escitalopram	7 in 1 BOTTLE	TABLET, FILM COATED	7	10
71335-1187-8	Escitalopram	180 in 1 BOTTLE	TABLET, FILM COATED	180	10
71335-1187-9	Escitalopram	100 in 1 BOTTLE	TABLET, FILM COATED	100	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-1187-1	EA - Each	71335-1187	19e0922a-32bc-42e5-9f21-df348419abba	1	2019-11-12
71335-1187-3	EA - Each	71335-1187	85fdbcaf-9f54-49f2-81da-2e334b8a2102	1	2019-06-19
71335-1187-4	EA - Each	71335-1187	76c6a400-753e-4ee9-bc15-ad49a7d9a404	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1187	ESCITALOPRAM TABLET, FILM COATED [BRYANT RANCH PREPACK]	10	Current NDC, Legacy NDC, 9 package rows	20240824_c842ec12-8792-47a9-82ad-9edf99e549ba.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 2 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Escitalopram	ESCITALOPRAM	Bryant Ranch Prepack	102c3893-4fdc-40b3-bd83-775e292723d7	2024-08-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
Escitalopram	ESCITALOPRAM	Bryant Ranch Prepack	c842ec12-8792-47a9-82ad-9edf99e549ba	2024-08-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032 ndc (product): 71335-1187
Escitalopram	ESCITALOPRAM	NuCare Pharmaceuticals,Inc.	a489600b-6ae0-edb7-e053-2a95a90a7d00	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
Escitalopram	ESCITALOPRAM	A-S Medication Solutions	2ffc6ec3-830f-46bc-9b3f-7c42cefa39b2	2024-04-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
Escitalopram	ESCITALOPRAM	A-S Medication Solutions	575d7755-0518-4d48-bb1a-4ad01321fde7	2023-12-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
Escitalopram	ESCITALOPRAM	A-S Medication Solutions	9b0b3c54-5bbc-4db9-9c69-00dac1347f24	2023-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
Escitalopram	ESCITALOPRAM	Proficient Rx LP	3e3de8ea-b96b-456b-9336-69380fd2d058	2023-03-01	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
349332	escitalopram oxalate 10 MG Oral Tablet	PSN	c842ec12-8792-47a9-82ad-9edf99e549ba	10
349332	escitalopram 10 MG Oral Tablet	SCD	c842ec12-8792-47a9-82ad-9edf99e549ba	10
349332	escitalopram (as escitalopram oxalate) 10 MG Oral Tablet	SY	c842ec12-8792-47a9-82ad-9edf99e549ba	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1187-1	71335118701	30 TABLET, FILM COATED in 1 BOTTLE (71335-1187-1)	2019-05-20	0000-00-00	No	No	Current
71335-1187-2	71335118702	28 TABLET, FILM COATED in 1 BOTTLE (71335-1187-2)	2024-04-03	0000-00-00	No	No	Current
71335-1187-3	71335118703	60 TABLET, FILM COATED in 1 BOTTLE (71335-1187-3)	2019-04-11	0000-00-00	No	No	Current
71335-1187-4	71335118704	90 TABLET, FILM COATED in 1 BOTTLE (71335-1187-4)	2019-05-15	0000-00-00	No	No	Current
71335-1187-5	71335118705	10 TABLET, FILM COATED in 1 BOTTLE (71335-1187-5)	2024-04-03	0000-00-00	No	No	Current
71335-1187-6	71335118706	120 TABLET, FILM COATED in 1 BOTTLE (71335-1187-6)	2024-04-03	0000-00-00	No	No	Current
71335-1187-7	71335118707	7 TABLET, FILM COATED in 1 BOTTLE (71335-1187-7)	2024-04-03	0000-00-00	No	No	Current
71335-1187-8	71335118708	180 TABLET, FILM COATED in 1 BOTTLE (71335-1187-8)	2024-04-03	0000-00-00	No	No	Current
71335-1187-9	71335118709	100 TABLET, FILM COATED in 1 BOTTLE (71335-1187-9)	2022-02-16	0000-00-00	No	No	Current