Citalopram

Product NDC: 68071-3357
Requested package NDC: 68071-3357-5
11-digit product format: 680713357
Labeler code: 68071
Product ID: 68071-3357_3880e5dd-0433-2990-e063-6394a90a0ef8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Citalopram Hydrobromide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA077031
Marketing category: ANDA
Marketing start: 2004-10-28
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

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
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A077031-001	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-10-28
A077031-002	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-10-28
A077031-003	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077031-001	AB
A077031-002	AB
A077031-003	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	A077031-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077031-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077031-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077031-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077031-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077031-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077031-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077031-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077031-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077031-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077031-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077031-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077031-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077031-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077031-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077031-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077031-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077031-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077031-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077031-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077031-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077031-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077031-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077031-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077031-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077031-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077031-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077031-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077031-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077031-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077031-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077031-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077031-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077031-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-10-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077031-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-10-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077031-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-10-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077031-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-10-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077031-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2004-10-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077031-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2004-10-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077031-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2004-10-28	`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	A077031-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077031-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077031-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077031-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077031-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077031-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077031-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077031-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077031-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077031-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077031-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077031-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077031-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077031-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077031-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077031-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077031-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077031-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077031-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077031-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077031-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077031-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077031-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077031-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077031-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077031-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077031-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077031-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077031-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077031-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077031-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077031-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077031-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077031-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077031-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077031-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077031-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077031-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077031-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077031-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Citalopram
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
544ba802-a536-579a-e054-00144ff88e88	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
68071-3357-1	2020-05-13	Citalopram Tablets, USP
68071-3357-3	2020-05-13	Citalopram Tablets, USP
68071-3357-4	2020-05-13	Citalopram Tablets, USP
68071-3357-5	2020-05-13	Citalopram Tablets, USP
68071-3357-6	2020-05-13	Citalopram Tablets, USP
68071-3357-9	2020-05-13	Citalopram Tablets, USP
68071-3357-1	2020-01-31	Citalopram Tablets, USP
68071-3357-3	2020-01-31	Citalopram Tablets, USP
68071-3357-4	2020-01-31	Citalopram Tablets, USP
68071-3357-5	2020-01-31	Citalopram Tablets, USP
68071-3357-6	2020-01-31	Citalopram Tablets, USP
68071-3357-9	2020-01-31	Citalopram Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-3357-1	Citalopram	15 in 1 BOTTLE	TABLET, FILM COATED	15	4
68071-3357-3	Citalopram	30 in 1 BOTTLE	TABLET, FILM COATED	30	4
68071-3357-4	Citalopram	40 in 1 BOTTLE	TABLET, FILM COATED	40	4
68071-3357-5	Citalopram	45 in 1 BOTTLE	TABLET, FILM COATED	45	4
68071-3357-6	Citalopram	60 in 1 BOTTLE	TABLET, FILM COATED	60	4
68071-3357-9	Citalopram	90 in 1 BOTTLE	TABLET, FILM COATED	90	4

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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Citalopram	CITALOPRAM HYDROBROMIDE	REMEDYREPACK INC.	625a78b2-4751-4ca5-91b6-7c85fd9f8c2e	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077031 application number: ANDA077031
Citalopram	CITALOPRAM HYDROBROMIDE	Northwind Health Company, LLC	d9cc1649-913d-832d-e053-2995a90a5f9a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077031 application number: ANDA077031
Citalopram	CITALOPRAM HYDROBROMIDE	Northwind Health Company, LLC	d9ccb3fb-b607-9491-e053-2995a90a39c9	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077031 application number: ANDA077031
Citalopram	CITALOPRAM HYDROBROMIDE	QPharma, Inc.	0a967468-3869-4c8c-849f-9fc3a8dcc489	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077031 application number: ANDA077031
Citalopram	CITALOPRAM HYDROBROMIDE	PD-Rx Pharmaceuticals, Inc.	31a18cdf-b0aa-18f5-e054-00144ff8d46c	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077031 application number: ANDA077031
Citalopram	CITALOPRAM HYDROBROMIDE	NuCare Pharmaceuticals,Inc.	544ba802-a536-579a-e054-00144ff88e88	2025-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077031 application number: ANDA077031 ndc (package): 68071-3357-5 ndc (product): 68071-3357 ndc11 (package): 68071335705
Citalopram	CITALOPRAM HYDROBROMIDE	Bryant Ranch Prepack	0bc0e09e-0f1d-4d52-b8fe-3ef8a2e5ea52	2025-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077031 application number: ANDA077031
Citalopram	CITALOPRAM HYDROBROMIDE	REMEDYREPACK INC.	0109f365-bebd-4810-a56f-4451e10245db	2025-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077031 application number: ANDA077031
Citalopram Hydrobromide	CITALOPRAM HYDROBROMIDE	Advanced Rx Pharmacy of Tennessee, LLC	f8b06b55-f6a2-2438-e053-6394a90a530a	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077031 application number: ANDA077031
Citalopram	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	2500cc9d-a67d-46c5-9a76-99bc63959d67	2024-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077031 application number: ANDA077031
Citalopram	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	b244d4eb-8311-4663-8bca-dc08e88e5f5d	2024-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077031 application number: ANDA077031
Citalopram	CITALOPRAM HYDROBROMIDE	QUALLENT PHARMACEUTICALS HEALTH LLC	e0822069-9672-4d4c-bc1a-8739b0dd045c	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077031 application number: ANDA077031
Citalopram	CITALOPRAM HYDROBROMIDE	Aurobindo Pharma Limited	2632b547-2e13-447f-ac85-c774e437d6a8	2024-05-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077031 application number: ANDA077031
Citalopram	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	fc766b76-18c1-42cd-b276-f720f5821c11	2024-04-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077031 application number: ANDA077031
Citalopram	CITALOPRAM HYDROBROMIDE	A-S Medication Solutions	c6730edc-7226-4521-a04a-1bf296b01b8d	2024-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077031 application number: ANDA077031
Citalopram	CITALOPRAM HYDROBROMIDE	NCS HealthCare of KY, LLC dba Vangard Labs	fd761647-e16b-45b3-a4bc-364de0ed7015	2023-09-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077031 application number: ANDA077031
Citalopram	CITALOPRAM HYDROBROMIDE	Proficient Rx LP	f37cc307-8b7d-4e5c-8beb-cd8779bc86a7	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077031 application number: ANDA077031
Citalopram	CITALOPRAM HYDROBROMIDE	Aphena Pharma Solutions - Tennessee, LLC	31ddd184-7560-473c-b674-5fa3187c5598	2020-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077031 application number: ANDA077031
Citalopram	CITALOPRAM HYDROBROMIDE	Proficient Rx LP	289c1d5e-902f-47db-85b8-5e1a55ec8684	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077031 application number: ANDA077031

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
309314	citalopram 40 MG Oral Tablet	PSN	544ba802-a536-579a-e054-00144ff88e88	4
309314	citalopram 40 MG Oral Tablet	SCD	544ba802-a536-579a-e054-00144ff88e88	4
309314	citalopram 40 MG (as citalopram HBr 49.98 MG) Oral Tablet	SY	544ba802-a536-579a-e054-00144ff88e88	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68071-3357-5	68071335705	45 TABLET, FILM COATED in 1 BOTTLE (68071-3357-5)	2017-07-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Citalopram Tablets, USP	NuCare Pharmaceuticals,Inc. \| NuCare Pharnaceuticals,Inc.	2025-06-26	HUMAN PRESCRIPTION DRUG LABEL	4