Escitalopram

Product NDC: 0615-8365
11-digit product format: 006158365
Labeler code: 0615
Product ID: 0615-8365_b94038e3-753b-4d35-9213-2a39ab567f9d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Escitalopram
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
Application: ANDA202389
Marketing category: ANDA
Marketing start: 2013-03-19
Marketing end: 0000-00-00
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: 2021-12-31
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	0615-8365		D	Discontinued by firm	2026-08-17
excluded package	package	0615-8365	0615-8365-05	D	Discontinued by firm	2026-08-17
excluded package	package	0615-8365	0615-8365-30	D	Discontinued by firm	2026-08-17
excluded package	package	0615-8365	0615-8365-39	D	Discontinued by firm	2026-08-17

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 · 48 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0615-8365-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0615-8365-39	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0615-8365-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0615-8365-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0615-8365-39	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0615-8365-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0615-8365-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0615-8365-39	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0615-8365-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0615-8365-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0615-8365-39	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0615-8365-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0615-8365-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0615-8365-39	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0615-8365-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0615-8365-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0615-8365-39	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0615-8365-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0615-8365-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0615-8365-39	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0615-8365-30	`302b2466d912…`	`e7b80fea0513…`
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	0615-8365-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0615-8365-39	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0615-8365-30	`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	0615-8365-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0615-8365-39	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0615-8365-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0615-8365-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0615-8365-39	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0615-8365-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0615-8365-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0615-8365-39	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0615-8365-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0615-8365-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0615-8365-39	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0615-8365-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A202389-001	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11
A202389-002	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11
A202389-003	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
A202389-001	AB
A202389-002	AB
A202389-003	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	A202389-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202389-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202389-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202389-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202389-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202389-003	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	A202389-001	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	A202389-002	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	A202389-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202389-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202389-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202389-003	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	A202389-001	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	A202389-002	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	A202389-003	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	A202389-001	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	A202389-002	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	A202389-003	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	A202389-001	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	A202389-002	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	A202389-003	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	A202389-001	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	A202389-002	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	A202389-003	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	A202389-001	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	A202389-002	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	A202389-003	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	A202389-001	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	A202389-002	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	A202389-003	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202389-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202389-002	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202389-003	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	A202389-001	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	A202389-002	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	A202389-003	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	A202389-001	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	A202389-002	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	A202389-003	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	A202389-001	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-09-11	`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	A202389-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202389-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202389-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202389-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202389-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202389-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202389-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202389-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202389-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202389-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202389-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202389-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202389-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202389-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202389-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202389-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202389-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202389-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202389-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202389-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202389-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202389-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202389-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202389-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202389-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202389-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202389-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202389-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202389-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202389-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202389-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202389-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202389-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202389-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202389-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202389-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202389-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202389-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202389-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202389-001	AB	1	`1e350fbaab3a…`

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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Escitalopram	ESCITALOPRAM	Bryant Ranch Prepack	43eb9e4f-1a46-46f7-9e9d-43e866963b37	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202389 application number: ANDA202389
Escitalopram	ESCITALOPRAM	PD-Rx Pharmaceuticals, Inc.	2d125ea4-5430-5b4e-e054-00144ff88e88	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202389 application number: ANDA202389
Escitalopram	ESCITALOPRAM	PD-Rx Pharmaceuticals, Inc.	83510549-bd47-4969-aba0-c149a0fbb7f3	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202389 application number: ANDA202389
Escitalopram	ESCITALOPRAM	Northwind Health Company, LLC	d9ba6c65-22bd-10c4-e053-2995a90ada2e	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202389 application number: ANDA202389
Escitalopram	ESCITALOPRAM	Northwind Health Company, LLC	dabf8bc0-5de6-edce-e053-2995a90a73c9	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202389 application number: ANDA202389
Escitalopram	ESCITALOPRAM	Northwind Health Company, LLC	c9f52332-8616-19d8-e053-2995a90ad753	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202389 application number: ANDA202389
Escitalopram	ESCITALOPRAM	Northwind Health Company, LLC	da7feb56-5f5a-7487-e053-2995a90a119e	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202389 application number: ANDA202389
Escitalopram	ESCITALOPRAM	Accord Healthcare Inc.	84b2028d-eff4-434d-b71e-6a3c0812f625	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202389 application number: ANDA202389
Escitalopram	ESCITALOPRAM	Bryant Ranch Prepack	d143ec01-9445-42d5-a259-b0b5a7f9445f	2025-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202389 application number: ANDA202389
Escitalopram	ESCITALOPRAM	Bryant Ranch Prepack	4966fd83-ee96-4f87-beb1-dd40d70de445	2025-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202389 application number: ANDA202389
Escitalopram	ESCITALOPRAM	NuCare Pharmaceuticals, Inc.	4a645652-ae1f-3811-e054-00144ff8d46c	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202389 application number: ANDA202389
Escitalopram	ESCITALOPRAM	NuCare Pharmaceuticals,Inc.	8e88bc86-d5e2-50ca-e053-2995a90a0f0e	2024-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202389 application number: ANDA202389
Escitalopram	ESCITALOPRAM	A-S Medication Solutions	16a07596-2a89-4897-a829-529452ceb1e8	2023-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202389 application number: ANDA202389
Escitalopram	ESCITALOPRAM	Proficient Rx LP	1df5c652-7bad-4b07-b33b-333071bc2670	2023-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202389 application number: ANDA202389
Escitalopram	ESCITALOPRAM	Proficient Rx LP	2fb28a40-037a-49a0-b418-6c6841885cf4	2022-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202389 application number: ANDA202389
Escitalopram	ESCITALOPRAM	Aphena Pharma Solutions - Tennessee, LLC	85b2f57e-53f3-4b93-9128-ad74cc34be4c	2020-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202389 application number: ANDA202389

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0615-8365-05	00615836505	15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8365-05)		2020-12-04	0000-00-00	No	No	Current
0615-8365-30	00615836530	6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8365-30) > 5 TABLET, FILM COATED in 1 BLISTER PACK	6 blister pack	2020-12-16	0000-00-00	No	No	Current
0615-8365-39	00615836539	30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8365-39)		2020-12-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Escitalopram	NCS HealthCare of KY, LLC dba Vangard Labs	2023-04-28	HUMAN PRESCRIPTION DRUG LABEL	3