Citalopram Hydrobromide

Product NDC: 53002-1579
Requested package NDC: 53002-1579-3
11-digit product format: 530021579
Labeler code: 53002
Product ID: 53002-1579_088c26a0-39d8-46a9-a9b6-08a3d22c2ae7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Citalopram Hydrobromide
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA078216
Marketing category: ANDA
Marketing start: 2007-10-18
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53002-1579	53002-1579-3	I	Inactivated by FDA		2026-10-05

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 · 11 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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
A078216-001	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27
A078216-002	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27
A078216-003	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078216-001	AB
A078216-002	AB
A078216-003	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	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`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	A078216-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078216-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078216-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078216-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078216-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078216-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078216-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078216-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078216-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078216-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078216-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078216-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078216-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078216-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078216-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078216-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078216-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078216-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078216-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078216-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078216-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078216-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078216-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078216-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078216-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078216-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078216-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078216-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078216-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078216-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078216-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078216-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078216-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078216-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078216-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078216-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078216-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078216-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078216-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078216-001	AB	1	`301d65b070ca…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53002-1579-0	2025-01-30	These highlights do not include all the information needed to use citalopram tablets safely and effectively. See full prescribing information for citalopram tablets. CITALOPRAM (Citalopram) tablets, for oral use Initial U.S. Approval: 1998
53002-1579-3	2025-01-30	These highlights do not include all the information needed to use citalopram tablets safely and effectively. See full prescribing information for citalopram tablets. CITALOPRAM (Citalopram) tablets, for oral use Initial U.S. Approval: 1998
53002-1579-0	2023-06-07	These highlights do not include all the information needed to use citalopram tablets safely and effectively. See full prescribing information for citalopram tablets. CITALOPRAM (Citalopram) tablets, for oral use Initial U.S. Approval: 1998
53002-1579-3	2023-06-07	These highlights do not include all the information needed to use citalopram tablets safely and effectively. See full prescribing information for citalopram tablets. CITALOPRAM (Citalopram) tablets, for oral use Initial U.S. Approval: 1998
53002-1579-0	2023-01-30	These highlights do not include all the information needed to use citalopram tablets safely and effectively. See full prescribing information for citalopram tablets. CITALOPRAM (Citalopram) tablets, for oral use Initial U.S. Approval: 1998
53002-1579-3	2023-01-30	These highlights do not include all the information needed to use citalopram tablets safely and effectively. See full prescribing information for citalopram tablets. CITALOPRAM (Citalopram) tablets, for oral use Initial U.S. Approval: 1998
53002-1579-0	2020-12-15	These highlights do not include all the information needed to use citalopram tablets safely and effectively. See full prescribing information for citalopram tablets. CITALOPRAM (Citalopram) tablets, for oral use Initial U.S. Approval: 1998
53002-1579-3	2020-12-15	These highlights do not include all the information needed to use citalopram tablets safely and effectively. See full prescribing information for citalopram tablets. CITALOPRAM (Citalopram) tablets, for oral use Initial U.S. Approval: 1998
53002-1579-0	2020-01-31	These highlights do not include all the information needed to use citalopram tablets safely and effectively. See full prescribing information for citalopram tablets. CITALOPRAM (Citalopram) tablets, for oral use Initial U.S. Approval: 1998
53002-1579-3	2020-01-31	These highlights do not include all the information needed to use citalopram tablets safely and effectively. See full prescribing information for citalopram tablets. CITALOPRAM (Citalopram) tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53002-1579-0	Citalopram Hydrobromide	100 in 1 BOTTLE	TABLET	100		8
53002-1579-3	Citalopram Hydrobromide	30 in 1 BOTTLE	TABLET	30		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-1579	CITALOPRAM HYDROBROMIDE TABLET [RPK PHARMACEUTICALS, INC.]	8	Legacy NDC, 2 package rows	20230609_8712b9a1-d8ef-4393-94f4-e1ab1fa41916.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 1 of 2 · 38 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Citalopram	CITALOPRAM	PD-Rx Pharmaceuticals, Inc.	9fe40d83-8945-4577-add5-28d52410154e	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	St. Mary's Medical Park Pharmacy	db900453-4777-4142-a236-5d3a6152d0a5	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	Coupler LLC	53e5d66f-7902-76ac-e063-6294a90aa526	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	Coupler LLC	53e6d0a4-95d9-9c1a-e063-6294a90a9d18	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	Bryant Ranch Prepack	9b53c14c-224c-49ed-8a00-96f871593ab0	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	ASCLEMED USA INC.	df8db06a-ced7-4dd6-83bd-c61d2f68f1b1	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	St. Mary's Medical Park Pharmacy	351ca54b-0eb6-4e93-8ab4-82fb18dcc9e1	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	QPharma, Inc.	f35bfd9e-afb6-409d-a804-6073d812609d	2026-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	PD-Rx Pharmaceuticals, Inc.	43785b49-5d1e-4ae9-b2ff-26be910bde7f	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	REMEDYREPACK INC.	a26772e7-6e4d-489b-bb5e-5bc322ef6dfe	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	PD-Rx Pharmaceuticals, Inc.	df929b3f-0cda-4a75-96d3-22e6b0edbbc9	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	REMEDYREPACK INC.	bdc0c228-797a-42dd-8114-aa68c1eb3300	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	Coupler LLC	50380ce5-c77f-3ee3-e063-6394a90a17ae	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	Cardinal Health 107, LLC	6c8942f8-963a-4007-a147-b77ac629e4d4	2026-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Preferred Pharmaceuticals Inc.	27ddea53-f03d-4760-99bb-ec8efa44ff62	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	Bryant Ranch Prepack	bef27fa1-7876-4ce3-834c-a4855aec66c9	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	Major Pharmaceuticals	a6949652-b15b-435b-9097-2219f398ac05	2026-02-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	Torrent Pharmaceuticals Limited	04766f1d-7a69-49ed-8fd3-1a6305505d47	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Preferred Pharmaceuticals, Inc.	b52acd68-fed1-4680-9eaf-b72e7dcba6fb	2026-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216
Citalopram	CITALOPRAM	Northwind Health Company, LLC	a7ef6ad2-5f22-4ac7-b57a-f498bcb53be1	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078216 application number: ANDA078216

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	8712b9a1-d8ef-4393-94f4-e1ab1fa41916	8
200371	citalopram 20 MG Oral Tablet	PSN	8712b9a1-d8ef-4393-94f4-e1ab1fa41916	8
283672	citalopram 10 MG Oral Tablet	SCD	8712b9a1-d8ef-4393-94f4-e1ab1fa41916	8
200371	citalopram 20 MG Oral Tablet	SCD	8712b9a1-d8ef-4393-94f4-e1ab1fa41916	8
283672	citalopram 10 MG (as citalopram HBr 12.49 MG) Oral Tablet	SY	8712b9a1-d8ef-4393-94f4-e1ab1fa41916	8
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	8712b9a1-d8ef-4393-94f4-e1ab1fa41916	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-1579-3	53002157903	30 TABLET in 1 BOTTLE (53002-1579-3)	30 tablet	2017-09-01	0000-00-00	No	No	Current