Citalopram Hydrobromide

Product NDC: 72657-109
Requested package NDC: 72657-109-05
11-digit product format: 726570109
Labeler code: 72657
Product ID: 72657-109_02b0183d-ff32-4c60-a899-c390d716b9e3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Citalopram Hydrobromide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Glenmark Therapeutics Inc., USA
Application: ANDA077654
Marketing category: ANDA
Marketing start: 2022-01-13
Marketing end: 0000-00-00
Substance: CITALOPRAM HYDROBROMIDE
Active strength: 10 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	72657-109	72657-109-05	D	Discontinued by firm		2026-10-12

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	Approval date
A077654-001	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	2009-02-27
A077654-002	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	2009-02-27
A077654-003	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	2009-02-27

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	A077654-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL		2009-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077654-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL		2009-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077654-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL		2009-02-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077654-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL		2009-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077654-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL		2009-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077654-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL		2009-02-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077654-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL		2009-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077654-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL		2009-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077654-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL		2009-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077654-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL		2009-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077654-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL		2009-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077654-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL		2009-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077654-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2009-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077654-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2009-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077654-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2009-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077654-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2009-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077654-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2009-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077654-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2009-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077654-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2009-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077654-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2009-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077654-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2009-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077654-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2009-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077654-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2009-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077654-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2009-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077654-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2009-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077654-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2009-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077654-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2009-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077654-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2009-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077654-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2009-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077654-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2009-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077654-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2009-02-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077654-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2009-02-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077654-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2009-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077654-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2009-02-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077654-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2009-02-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077654-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2009-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077654-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2009-02-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077654-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2009-02-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077654-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2009-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077654-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2009-02-27	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A077654-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077654-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077654-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077654-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077654-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077654-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077654-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077654-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077654-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077654-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077654-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077654-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077654-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077654-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077654-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077654-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077654-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077654-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077654-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077654-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077654-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077654-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077654-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077654-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077654-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077654-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077654-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077654-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077654-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077654-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077654-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077654-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077654-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077654-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077654-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077654-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077654-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077654-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077654-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077654-001	AB	1	`5d02ea3f76ae…`

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
475812f9-1b2c-4cb0-9e72-1e52f935ae6f	Product name	1	20221114
0b05d650-9b7b-4b36-a6f4-1a850d5a2e64	Product name	1	20151228
e61ea6cb-0b08-40a9-a984-7b23201c7aa2	Product name	1	20151222

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72657-109-01	Citalopram Hydrobromide	100 in 1 BOTTLE	TABLET, FILM COATED	100		4
72657-109-05	Citalopram Hydrobromide	500 in 1 BOTTLE	TABLET, FILM COATED	500		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72657-109	CITALOPRAM HYDROBROMIDE TABLET, FILM COATED [GLENMARK THERAPEUTICS INC., USA]	4	Legacy NDC, 2 package rows	20240605_18330b41-27ad-461b-a0a9-aac94e8ee87f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I1E9D14F36	CITALOPRAM HYDROBROMIDE	59729-32-7	CITALOPRAM HYDROBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
283672	citalopram 10 MG Oral Tablet	PSN	18330b41-27ad-461b-a0a9-aac94e8ee87f	4
200371	citalopram 20 MG Oral Tablet	PSN	18330b41-27ad-461b-a0a9-aac94e8ee87f	4
309314	citalopram 40 MG Oral Tablet	PSN	18330b41-27ad-461b-a0a9-aac94e8ee87f	4
283672	citalopram 10 MG Oral Tablet	SCD	18330b41-27ad-461b-a0a9-aac94e8ee87f	4
200371	citalopram 20 MG Oral Tablet	SCD	18330b41-27ad-461b-a0a9-aac94e8ee87f	4
309314	citalopram 40 MG Oral Tablet	SCD	18330b41-27ad-461b-a0a9-aac94e8ee87f	4
283672	citalopram 10 MG (as citalopram HBr 12.49 MG) Oral Tablet	SY	18330b41-27ad-461b-a0a9-aac94e8ee87f	4
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	18330b41-27ad-461b-a0a9-aac94e8ee87f	4
309314	citalopram 40 MG (as citalopram HBr 49.98 MG) Oral Tablet	SY	18330b41-27ad-461b-a0a9-aac94e8ee87f	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72657-109-05	72657010905	500 TABLET, FILM COATED in 1 BOTTLE (72657-109-05)	2022-01-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Citalopram Hydrobromide	Glenmark Therapeutics Inc., USA \| Glenmark Pharmaceuticals Limited	2024-05-10	HUMAN PRESCRIPTION DRUG LABEL	4