Escitalopram

Product NDC: 51672-1348
11-digit product format: 516721348
Labeler code: 51672
Product ID: 51672-1348_aa5df9db-13f0-4170-a0d5-2ec8db37c373
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Escitalopram Oxalate
Dosage form: SOLUTION
Route: ORAL
Labeler: Taro Pharmaceuticals U.S.A., Inc.
Application: ANDA079121
Marketing category: ANDA
Marketing start: 2012-05-03
Marketing end: 0000-00-00
Substance: ESCITALOPRAM OXALATE
Active strength: 5 mg/5mL
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51672-1348		D	Discontinued by firm	2026-11-03
excluded package	package	51672-1348	51672-1348-1	D	Discontinued by firm	2026-11-03
excluded package	package	51672-1348	51672-1348-8	D	Discontinued by firm	2026-11-03
excluded package	package	51672-1348	51672-1348-9	D	Discontinued by firm	2026-11-03

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A079121-001	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL			2012-05-03

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 2 · 44 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	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL		2012-05-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL		2012-05-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL		2012-05-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL		2012-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL		2012-05-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079121-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2012-05-03	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A079121-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079121-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079121-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079121-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079121-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079121-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079121-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079121-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079121-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079121-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079121-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079121-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079121-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079121-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079121-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079121-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079121-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079121-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079121-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079121-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079121-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079121-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079121-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079121-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079121-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079121-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079121-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079121-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079121-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079121-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079121-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079121-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079121-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079121-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079121-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079121-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079121-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079121-001	AA	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

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
51672-1348-1	Escitalopram	240 mL in 1 BOTTLE	SOLUTION	240	13
51672-1348-1	Escitalopram	1 in 1 CARTON	SOLUTION	1	13
51672-1348-8	Escitalopram	1 in 1 CARTON	SOLUTION	1	13
51672-1348-8	Escitalopram	120 mL in 1 BOTTLE	SOLUTION	120	13
51672-1348-9	Escitalopram	480 mL in 1 BOTTLE	SOLUTION	480	13
51672-1348-9	Escitalopram	1 in 1 CARTON	SOLUTION	1	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-1348-1	ML - Milliliter	51672-1348	8e4fe186-118e-408c-af78-78019744d31e	1	2013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Escitalopram Oxalate	ACTIVE INGREDIENT	5U85DBW7LO	ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	8
Escitalopram	ACTIVE MOIETY	4O4S742ANY	ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	8
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	8
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	8
malic acid	INACTIVE INGREDIENT	817L1N4CKP	ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	8
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	8
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	8
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	8
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	8
sorbitol	INACTIVE INGREDIENT	506T60A25R	ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	8
water	INACTIVE INGREDIENT	059QF0KO0R	ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-1348	ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	12	Legacy NDC, 6 package rows	20210703_c871d3fe-5ca2-410c-976d-9ec4b72c878f.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
351285	escitalopram 5 MG in 5 mL Oral Solution	PSN	c871d3fe-5ca2-410c-976d-9ec4b72c878f	13
351285	escitalopram 1 MG/ML Oral Solution	SCD	c871d3fe-5ca2-410c-976d-9ec4b72c878f	13
351285	escitalopram (as escitalopram oxalate) 10 MG per 10 ML Oral Solution	SY	c871d3fe-5ca2-410c-976d-9ec4b72c878f	13
351285	escitalopram (as escitalopram oxalate) 5 MG per 5 ML Oral Solution	SY	c871d3fe-5ca2-410c-976d-9ec4b72c878f	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-1348-1	51672134801	1 BOTTLE in 1 CARTON (51672-1348-1) > 240 mL in 1 BOTTLE	1 bottle	2012-05-03	0000-00-00	No	No	Current
51672-1348-8	51672134808	1 BOTTLE in 1 CARTON (51672-1348-8) > 120 mL in 1 BOTTLE	1 bottle	2012-05-03	0000-00-00	No	No	Current
51672-1348-9	51672134809	1 BOTTLE in 1 CARTON (51672-1348-9) > 480 mL in 1 BOTTLE	1 bottle	2012-05-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Escitalopram	Sun Pharmaceutical Industries, Inc. \| Sun Pharma Canada Inc.	2025-07-01	HUMAN PRESCRIPTION DRUG LABEL	13