CITALOPRAM HYDROBROMIDE

Product NDC: 76282-208
11-digit product format: 762820208
Labeler code: 76282
Product ID: 76282-208_fd69f24e-8108-4b9e-92ca-13ebbdf86e45
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CITALOPRAM
Dosage form: TABLET
Route: ORAL
Labeler: Exelan Pharmaceuticals Inc.
Application: ANDA077534
Marketing category: ANDA
Marketing start: 2012-10-01
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
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…`

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
a8e8fde2-8392-4d5b-902b-e2b9dd55a02d	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76282-208-05	CITALOPRAM HYDROBROMIDE	500 in 1 BOTTLE	TABLET	500	15
76282-208-10	CITALOPRAM HYDROBROMIDE	1000 in 1 BOTTLE	TABLET	1000	15
76282-208-30	CITALOPRAM HYDROBROMIDE	30 in 1 BOTTLE	TABLET	30	15
76282-208-90	CITALOPRAM HYDROBROMIDE	90 in 1 BOTTLE	TABLET	90	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76282-208-01	EA - Each	76282-208	2f395c5a-7bf1-4b00-9b6d-09bb7957a7c7	1	2013-02-13
76282-208-05	EA - Each	76282-208	9bd5dca2-1b6b-4070-9fe8-be1eb7aec31c	1	2013-02-13
76282-208-10	EA - Each	76282-208	c7681eb7-5aa6-4582-9cfd-fc7b0c186098	1	2013-02-13
76282-208-30	EA - Each	76282-208	68c2e058-4593-4b8a-afca-6e766e300dcc	1	2013-02-13
76282-208-90	EA - Each	76282-208	be2d5169-e537-4b61-bcbd-ebf40beac752	1	2017-09-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [EXELAN PHARMACEUTICALS INC.]	2
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [EXELAN PHARMACEUTICALS INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [EXELAN PHARMACEUTICALS INC.]	2
COPOVIDONE	INACTIVE INGREDIENT	D9C330MD8B	CITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [EXELAN PHARMACEUTICALS INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [EXELAN PHARMACEUTICALS INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [EXELAN PHARMACEUTICALS INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [EXELAN PHARMACEUTICALS INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76282-208	CITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [EXELAN PHARMACEUTICALS INC.]	15	Current NDC, Legacy NDC, 4 package rows	20240912_a8e8fde2-8392-4d5b-902b-e2b9dd55a02d.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 ndc (product): 76282-208
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
283672	citalopram 10 MG Oral Tablet	PSN	a8e8fde2-8392-4d5b-902b-e2b9dd55a02d	15
200371	citalopram 20 MG Oral Tablet	PSN	a8e8fde2-8392-4d5b-902b-e2b9dd55a02d	15
309314	citalopram 40 MG Oral Tablet	PSN	a8e8fde2-8392-4d5b-902b-e2b9dd55a02d	15
283672	citalopram 10 MG Oral Tablet	SCD	a8e8fde2-8392-4d5b-902b-e2b9dd55a02d	15
200371	citalopram 20 MG Oral Tablet	SCD	a8e8fde2-8392-4d5b-902b-e2b9dd55a02d	15
309314	citalopram 40 MG Oral Tablet	SCD	a8e8fde2-8392-4d5b-902b-e2b9dd55a02d	15
283672	citalopram 10 MG (as citalopram HBr 12.49 MG) Oral Tablet	SY	a8e8fde2-8392-4d5b-902b-e2b9dd55a02d	15
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	a8e8fde2-8392-4d5b-902b-e2b9dd55a02d	15
309314	citalopram 40 MG (as citalopram HBr 49.98 MG) Oral Tablet	SY	a8e8fde2-8392-4d5b-902b-e2b9dd55a02d	15
200371	citalopram 20 MG Oral Tablet	PSN	7307df53-d570-4e26-971d-e97522ccce7f	6
309314	citalopram 40 MG Oral Tablet	PSN	7307df53-d570-4e26-971d-e97522ccce7f	6
200371	citalopram 20 MG Oral Tablet	SCD	7307df53-d570-4e26-971d-e97522ccce7f	6
309314	citalopram 40 MG Oral Tablet	SCD	7307df53-d570-4e26-971d-e97522ccce7f	6
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	7307df53-d570-4e26-971d-e97522ccce7f	6
309314	citalopram 40 MG (as citalopram HBr 49.98 MG) Oral Tablet	SY	7307df53-d570-4e26-971d-e97522ccce7f	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76282-208-05	76282020805	500 TABLET in 1 BOTTLE (76282-208-05)	500 tablet	2012-10-01	0000-00-00	No	No	Current
76282-208-10	76282020810	1000 TABLET in 1 BOTTLE (76282-208-10)	1000 tablet	2012-10-01	0000-00-00	No	No	Current
76282-208-30	76282020830	30 TABLET in 1 BOTTLE (76282-208-30)	30 tablet	2012-10-01	0000-00-00	No	No	Current
76282-208-90	76282020890	90 TABLET in 1 BOTTLE (76282-208-90)	90 tablet	2017-05-01	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	2026-03-04	HUMAN PRESCRIPTION DRUG LABEL	6
CITALOPRAM HYDROBROMIDE	Exelan Pharmaceuticals Inc. \| InvaGen Pharmaceuticals Inc.	2024-08-01	HUMAN PRESCRIPTION DRUG LABEL	15