Citalopram

Product NDC: 43353-091
11-digit product format: 433530091
Labeler code: 43353
Product ID: 43353-091_ed5be4fc-b241-4d4f-9c66-85d764eea8cd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Citalopram
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA077534
Marketing category: ANDA
Marketing start: 2011-01-01
Marketing end: 0000-00-00
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: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	43353-091		D	Discontinued by firm		2026-08-11
excluded package	package	43353-091	43353-091-30	D	Discontinued by firm		2026-08-11

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
A077534-001	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-10-03
A077534-002	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-10-03
A077534-003	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-10-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077534-001	AB
A077534-002	AB
A077534-003	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	A077534-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077534-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077534-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077534-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077534-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077534-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077534-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077534-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077534-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077534-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077534-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077534-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077534-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077534-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077534-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077534-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077534-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077534-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077534-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077534-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077534-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077534-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077534-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077534-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077534-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077534-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077534-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077534-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077534-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077534-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077534-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077534-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077534-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077534-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-10-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077534-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-10-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077534-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077534-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-10-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077534-002	CITALOPRAM HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2006-10-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077534-003	CITALOPRAM HYDROBROMIDE	EQ 40MG BASE	TABLET / ORAL	AB	2006-10-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077534-001	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2006-10-03	`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	A077534-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077534-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077534-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077534-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077534-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077534-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077534-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077534-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077534-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077534-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077534-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077534-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077534-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077534-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077534-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077534-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077534-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077534-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077534-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077534-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077534-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077534-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077534-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077534-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077534-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077534-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077534-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077534-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077534-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077534-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077534-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077534-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077534-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077534-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077534-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077534-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077534-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077534-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077534-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077534-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-091-30	EA - Each	43353-091	2d9c2ddb-19de-421b-bd13-4570c9ea2918	1	2016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-091	CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC	20160707_c5f1279b-3b04-4e48-ac8e-0df06f5da278.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 1 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Citalopram	CITALOPRAM	REMEDYREPACK INC.	c9809dfe-939e-4f9d-b6dd-f9808fd9f2b1	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077534 application number: ANDA077534
Citalopram	CITALOPRAM	REMEDYREPACK INC.	25b0d184-2a4c-42b0-9a57-7a00fa3e0cd7	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077534 application number: ANDA077534
CITALOPRAM HYDROBROMIDE	CITALOPRAM	Aphena Pharma Solutions - Tennessee, LLC	7307df53-d570-4e26-971d-e97522ccce7f	2026-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077534 application number: ANDA077534
Citalopram	CITALOPRAM	Northwind Health Company, LLC	f2b42bdc-47e0-19c5-e053-2a95a90a1828	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077534 application number: ANDA077534
Citalopram	CITALOPRAM	Northwind Health Company, LLC	f2b54f10-221f-5eed-e053-2995a90ab47f	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077534 application number: ANDA077534
Citalopram	CITALOPRAM	Northwind Health Company, LLC	f77ef23b-3015-d074-e053-6394a90a11e1	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077534 application number: ANDA077534
Citalopram	CITALOPRAM	Cipla USA Inc.	0580559a-783a-4a0a-8d81-ee30a29077c5	2024-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077534 application number: ANDA077534
CITALOPRAM HYDROBROMIDE	CITALOPRAM	Exelan Pharmaceuticals Inc.	a8e8fde2-8392-4d5b-902b-e2b9dd55a02d	2024-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077534 application number: ANDA077534
Citalopram	CITALOPRAM	A-S Medication Solutions	c91684c7-fddb-4cf0-9711-b0484c8c7e8b	2024-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077534 application number: ANDA077534
Citalopram	CITALOPRAM	A-S Medication Solutions	17af7a8d-ef57-4253-96ed-e457e0062eb5	2024-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077534 application number: ANDA077534
Citalopram	CITALOPRAM	A-S Medication Solutions	04ac5286-fc2e-4990-a574-ea21131ef731	2024-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077534 application number: ANDA077534
Citalopram	CITALOPRAM	Aphena Pharma Solutions - Tennessee, LLC	0867140e-a483-4bf7-8326-4a9730cc9d9d	2020-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077534 application number: ANDA077534
CITALOPRAM HYDROBROMIDE	CITALOPRAM	Aphena Pharma Solutions - Tennessee, LLC	d05f4e71-95f3-4f22-8b01-b21e5c19e0f2	2018-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077534 application number: ANDA077534

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I1E9D14F36	CITALOPRAM HYDROBROMIDE	59729-32-7	CITALOPRAM HYDROBROMIDE
0DHU5B8D6V	CITALOPRAM	59729-33-8	Citalopram

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-091-30	43353009130	30 TABLET in 1 BOTTLE (43353-091-30)	30 tablet	2015-07-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Citalopram Tablets, USP Rx Only	Aphena Pharma Solutions - Tennessee, LLC	2016-06-14	HUMAN PRESCRIPTION DRUG LABEL	1