Citalopram Hydrobromide

Product NDC: 50090-3208
11-digit product format: 500903208
Labeler code: 50090
Product ID: 50090-3208_62db333a-b8cc-414a-b4c2-18bceabb8691
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Citalopram Hydrobromide
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA078216
Marketing category: ANDA
Marketing start: 2007-10-18
Substance: CITALOPRAM HYDROBROMIDE
Active strength: 40 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 123 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
2026-02-19 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078216-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078216-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078216-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-27	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078216-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078216-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078216-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078216-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078216-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078216-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Citalopram Hydrobromide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CITALOPRAM HYDROBROMIDE	40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
I1E9D14F36	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200371	Internal RxNorm lookup
283672	Internal RxNorm lookup
309314	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
05421bee-f746-418e-bb9c-ab44a89b567d	Available on FDA.report

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
50090-3208-0	2023-02-07	These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
50090-3208-1	2023-02-07	These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
50090-3208-2	2023-02-07	These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
50090-3208-0	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 tablets, for oral use Initial U.S. Approval: 1998
50090-3208-1	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 tablets, for oral use Initial U.S. Approval: 1998
50090-3208-2	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 tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-3208-0	Citalopram Hydrobromide	30 in 1 BOTTLE	TABLET	30	32
50090-3208-1	Citalopram Hydrobromide	100 in 1 BOTTLE	TABLET	100	32
50090-3208-2	Citalopram Hydrobromide	90 in 1 BOTTLE	TABLET	90	32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-3208-0	EA - Each	50090-3208	05469346-320e-4310-8f69-4a480059f65a	1	2018-12-13
50090-3208-1	EA - Each	50090-3208	4fae9114-9077-40af-b1cc-ccebecd7aa24	1	2018-12-13
50090-3208-2	EA - Each	50090-3208	1be49507-98a5-4fdd-a532-618a28a11709	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3208	CITALOPRAM HYDROBROMIDE TABLET [A-S MEDICATION SOLUTIONS]	32	Current NDC, Legacy NDC, 3 package rows	20240926_05421bee-f746-418e-bb9c-ab44a89b567d.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 · 39 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	05421bee-f746-418e-bb9c-ab44a89b567d	32
200371	citalopram 20 MG Oral Tablet	PSN	05421bee-f746-418e-bb9c-ab44a89b567d	32
309314	citalopram 40 MG Oral Tablet	PSN	05421bee-f746-418e-bb9c-ab44a89b567d	32
283672	citalopram 10 MG Oral Tablet	SCD	05421bee-f746-418e-bb9c-ab44a89b567d	32
200371	citalopram 20 MG Oral Tablet	SCD	05421bee-f746-418e-bb9c-ab44a89b567d	32
309314	citalopram 40 MG Oral Tablet	SCD	05421bee-f746-418e-bb9c-ab44a89b567d	32
283672	citalopram 10 MG (as citalopram HBr 12.49 MG) Oral Tablet	SY	05421bee-f746-418e-bb9c-ab44a89b567d	32
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	05421bee-f746-418e-bb9c-ab44a89b567d	32
309314	citalopram 40 MG (as citalopram HBr 49.98 MG) Oral Tablet	SY	05421bee-f746-418e-bb9c-ab44a89b567d	32

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3208-0	50090320800	30 TABLET in 1 BOTTLE (50090-3208-0)	30 tablet	2017-10-24	0000-00-00	No	No	Current
50090-3208-1	50090320801	100 TABLET in 1 BOTTLE (50090-3208-1)	100 tablet	2017-10-26	0000-00-00	No	No	Current
50090-3208-2	50090320802	90 TABLET in 1 BOTTLE (50090-3208-2)	90 tablet	2017-10-24	0000-00-00	No	No	Current