Escitalopram

Product NDC: 72189-451
11-digit product format: 721890451
Labeler code: 72189
Product ID: 72189-451_46164771-c4bd-9879-e063-6294a90ad050
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Escitalopram
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Direct_Rx
Application: ANDA078032
Marketing category: ANDA
Marketing start: 2023-03-30
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: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-451-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-451-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-451-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-451-60	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 129 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
2026-09-14 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…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
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…`

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	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
f81e3858-f01e-1df6-e053-6394a90aef4f	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
72189-451-30	Escitalopram	30 in 1 BOTTLE	TABLET, FILM COATED	30	3
72189-451-60	Escitalopram	60 in 1 BOTTLE	TABLET, FILM COATED	60	3
72189-451-90	Escitalopram	90 in 1 BOTTLE	TABLET, FILM COATED	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-451-30	EA - Each	72189-451	819fccc8-f3fb-4f3e-80af-e4f0698d702c	1	2023-04-07
72189-451-60	EA - Each	72189-451	173c0f90-2ffb-416e-be32-416046b1c6be	1	2023-04-07
72189-451-90	EA - Each	72189-451	fb0de3be-a647-4c40-ad29-96dfbbc880ee	1	2026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-451	ESCITALOPRAM TABLET, FILM COATED [DIRECT_RX]	2	Current NDC, 3 package rows	20250123_f81e3858-f01e-1df6-e053-6394a90aef4f.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 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Escitalopram	ESCITALOPRAM	Advanced Rx Pharmacy of Tennessee, LLC	f914fec5-4ce7-794d-e053-6294a90a7cc5	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078032 application number: ANDA078032
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
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
351250	escitalopram oxalate 20 MG Oral Tablet	PSN	f81e3858-f01e-1df6-e053-6394a90aef4f	3
351250	escitalopram 20 MG Oral Tablet	SCD	f81e3858-f01e-1df6-e053-6394a90aef4f	3
351250	escitalopram (as escitalopram oxalate) 20 MG Oral Tablet	SY	f81e3858-f01e-1df6-e053-6394a90aef4f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72189-451-30	72189045130	30 TABLET, FILM COATED in 1 BOTTLE (72189-451-30)	2023-03-30	No	No	Current
72189-451-60	72189045160	60 TABLET, FILM COATED in 1 BOTTLE (72189-451-60)	2023-03-30	No	No	Current
72189-451-90	72189045190	90 TABLET, FILM COATED in 1 BOTTLE (72189-451-90)	2023-03-30	No	No	Current