Citalopram

Product NDC: 13668-011
11-digit product format: 136680011
Labeler code: 13668
Product ID: 13668-011_48423caf-4df2-4653-a8ed-b28462757ed3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Citalopram
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Torrent Pharmaceuticals Limited
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: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Citalopram
Listing expiration: 2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	I1E9D14F36
Rxcui	200371, 283672, 309314

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
13668-011-01	Citalopram	100 in 1 BOTTLE	TABLET, FILM COATED	100	23
13668-011-05	Citalopram	500 in 1 BOTTLE	TABLET, FILM COATED	500	23
13668-011-08	Citalopram	2800 in 1 BOTTLE	TABLET, FILM COATED	2800	23
13668-011-30	Citalopram	30 in 1 BOTTLE	TABLET, FILM COATED	30	23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-011-01	EA - Each	13668-011	2e53bb75-95af-469e-bb0b-8140370f2fc0	1	2012-07-24
13668-011-05	EA - Each	13668-011	3a1f9923-75b9-48f1-bf91-b6d2771c6958	1	2012-07-24
13668-011-08	EA - Each	13668-011	0d73bc23-b13b-4b84-949c-f2b56ac5b21c	1	2012-07-24
13668-011-30	EA - Each	13668-011	cd545c7a-806a-4ee2-8082-3432c67f6c30	1	2012-07-24
13668-011-74	EA - Each	13668-011	83dc3960-b389-4afb-bbdd-8f329f821363	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM HYDROBROMIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	8
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	8
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM HYDROBROMIDE TABLET [STAT RX USA]	2
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [STAT RX USA]	2
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM HYDROBROMIDE TABLET [MEDVANTX, INC.]	1
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM HYDROBROMIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	DIRECT RX (CITALOPRAM) TABLET [DIRECT RX]	1
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM HYDROBROMIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM HYDROBROMIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [MEDVANTX, INC.]	1
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	DIRECT RX (CITALOPRAM) TABLET [DIRECT RX]	1
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM HYDROBROMIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13668-011	CITALOPRAM TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]	22	Current NDC, Legacy NDC, 4 package rows	20250125_04766f1d-7a69-49ed-8fd3-1a6305505d47.zip

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
309314	citalopram 40 MG Oral Tablet	PSN	15cb00da-4435-4930-90d0-faadf2739a5c	108
309314	citalopram 40 MG Oral Tablet	SCD	15cb00da-4435-4930-90d0-faadf2739a5c	108
309314	citalopram 40 MG (as citalopram HBr 49.98 MG) Oral Tablet	SY	15cb00da-4435-4930-90d0-faadf2739a5c	108
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
309314	citalopram 40 MG Oral Tablet	PSN	9fe40d83-8945-4577-add5-28d52410154e	25
309314	citalopram 40 MG Oral Tablet	SCD	9fe40d83-8945-4577-add5-28d52410154e	25
309314	citalopram 40 MG (as citalopram HBr 49.98 MG) Oral Tablet	SY	9fe40d83-8945-4577-add5-28d52410154e	25
283672	citalopram 10 MG Oral Tablet	PSN	04766f1d-7a69-49ed-8fd3-1a6305505d47	23
200371	citalopram 20 MG Oral Tablet	PSN	04766f1d-7a69-49ed-8fd3-1a6305505d47	23
309314	citalopram 40 MG Oral Tablet	PSN	04766f1d-7a69-49ed-8fd3-1a6305505d47	23
283672	citalopram 10 MG Oral Tablet	SCD	04766f1d-7a69-49ed-8fd3-1a6305505d47	23
200371	citalopram 20 MG Oral Tablet	SCD	04766f1d-7a69-49ed-8fd3-1a6305505d47	23
309314	citalopram 40 MG Oral Tablet	SCD	04766f1d-7a69-49ed-8fd3-1a6305505d47	23
283672	citalopram 10 MG (as citalopram HBr 12.49 MG) Oral Tablet	SY	04766f1d-7a69-49ed-8fd3-1a6305505d47	23
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	04766f1d-7a69-49ed-8fd3-1a6305505d47	23
309314	citalopram 40 MG (as citalopram HBr 49.98 MG) Oral Tablet	SY	04766f1d-7a69-49ed-8fd3-1a6305505d47	23
309314	citalopram 40 MG Oral Tablet	PSN	27ddea53-f03d-4760-99bb-ec8efa44ff62	11
309314	citalopram 40 MG Oral Tablet	SCD	27ddea53-f03d-4760-99bb-ec8efa44ff62	11
309314	citalopram 40 MG (as citalopram HBr 49.98 MG) Oral Tablet	SY	27ddea53-f03d-4760-99bb-ec8efa44ff62	11
309314	citalopram 40 MG Oral Tablet	PSN	35b05031-3319-4806-92af-72fbe2ec04ac	8
309314	citalopram 40 MG Oral Tablet	SCD	35b05031-3319-4806-92af-72fbe2ec04ac	8
309314	citalopram 40 MG (as citalopram HBr 49.98 MG) Oral Tablet	SY	35b05031-3319-4806-92af-72fbe2ec04ac	8
200371	citalopram 20 MG Oral Tablet	PSN	a7ef6ad2-5f22-4ac7-b57a-f498bcb53be1	5
309314	citalopram 40 MG Oral Tablet	PSN	a7ef6ad2-5f22-4ac7-b57a-f498bcb53be1	5
309314	citalopram 40 MG Oral Tablet	PSN	83e7ab2a-cf40-490b-aa7e-2ace88a7445d	5
200371	citalopram 20 MG Oral Tablet	SCD	a7ef6ad2-5f22-4ac7-b57a-f498bcb53be1	5
309314	citalopram 40 MG Oral Tablet	SCD	83e7ab2a-cf40-490b-aa7e-2ace88a7445d	5
309314	citalopram 40 MG Oral Tablet	SCD	a7ef6ad2-5f22-4ac7-b57a-f498bcb53be1	5
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	a7ef6ad2-5f22-4ac7-b57a-f498bcb53be1	5
309314	citalopram 40 MG (as citalopram HBr 49.98 MG) Oral Tablet	SY	a7ef6ad2-5f22-4ac7-b57a-f498bcb53be1	5
309314	citalopram 40 MG (as citalopram HBr 49.98 MG) Oral Tablet	SY	83e7ab2a-cf40-490b-aa7e-2ace88a7445d	5
309314	citalopram 40 MG Oral Tablet	PSN	356f48c3-3b0e-65b5-e054-00144ff8d46c	4
309314	citalopram 40 MG Oral Tablet	SCD	356f48c3-3b0e-65b5-e054-00144ff8d46c	4
309314	citalopram 40 MG (as citalopram HBr 49.98 MG) Oral Tablet	SY	356f48c3-3b0e-65b5-e054-00144ff8d46c	4
309314	citalopram 40 MG Oral Tablet	PSN	549a5b3f-4928-1ae5-e054-00144ff8d46c	3
309314	citalopram 40 MG Oral Tablet	SCD	549a5b3f-4928-1ae5-e054-00144ff8d46c	3
309314	citalopram 40 MG (as citalopram HBr 49.98 MG) Oral Tablet	SY	549a5b3f-4928-1ae5-e054-00144ff8d46c	3
283672	citalopram 10 MG Oral Tablet	PSN	26683db8-b319-4d67-8cd8-3c9803daa628	2
200371	citalopram 20 MG Oral Tablet	PSN	26683db8-b319-4d67-8cd8-3c9803daa628	2
309314	citalopram 40 MG Oral Tablet	PSN	00a3e8f8-530b-4355-b959-3eaa2542eed3	2
309314	citalopram 40 MG Oral Tablet	PSN	26683db8-b319-4d67-8cd8-3c9803daa628	2
283672	citalopram 10 MG Oral Tablet	SCD	26683db8-b319-4d67-8cd8-3c9803daa628	2
200371	citalopram 20 MG Oral Tablet	SCD	26683db8-b319-4d67-8cd8-3c9803daa628	2
309314	citalopram 40 MG Oral Tablet	SCD	26683db8-b319-4d67-8cd8-3c9803daa628	2
309314	citalopram 40 MG Oral Tablet	SCD	00a3e8f8-530b-4355-b959-3eaa2542eed3	2
283672	citalopram 10 MG (as citalopram HBr 12.49 MG) Oral Tablet	SY	26683db8-b319-4d67-8cd8-3c9803daa628	2
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	26683db8-b319-4d67-8cd8-3c9803daa628	2
309314	citalopram 40 MG (as citalopram HBr 49.98 MG) Oral Tablet	SY	00a3e8f8-530b-4355-b959-3eaa2542eed3	2
309314	citalopram 40 MG (as citalopram HBr 49.98 MG) Oral Tablet	SY	26683db8-b319-4d67-8cd8-3c9803daa628	2
283672	citalopram 10 MG Oral Tablet	PSN	34d1685a-8e6a-46bc-8977-550979bf4ddd	1
283672	citalopram 10 MG Oral Tablet	PSN	3993eb55-f0e8-496c-a496-19dc509699e8	1
283672	citalopram 10 MG Oral Tablet	PSN	16715e29-86e8-48b3-8c12-da70e5893901	1
200371	citalopram 20 MG Oral Tablet	PSN	3993eb55-f0e8-496c-a496-19dc509699e8	1
200371	citalopram 20 MG Oral Tablet	PSN	16715e29-86e8-48b3-8c12-da70e5893901	1
200371	citalopram 20 MG Oral Tablet	PSN	34d1685a-8e6a-46bc-8977-550979bf4ddd	1
309314	citalopram 40 MG Oral Tablet	PSN	e844a4cf-bbab-21a0-e053-2995a90a1f6c	1
309314	citalopram 40 MG Oral Tablet	PSN	b6052b11-a7c1-4f55-8ef5-239541c466ff	1
309314	citalopram 40 MG Oral Tablet	PSN	16715e29-86e8-48b3-8c12-da70e5893901	1
309314	citalopram 40 MG Oral Tablet	PSN	9059c8f1-8755-492d-aba2-5f5088ce69d3	1
309314	citalopram 40 MG Oral Tablet	PSN	34d1685a-8e6a-46bc-8977-550979bf4ddd	1
309314	citalopram 40 MG Oral Tablet	PSN	4eb71151-241a-476e-a495-4a021bc55bda	1
309314	citalopram 40 MG Oral Tablet	PSN	3993eb55-f0e8-496c-a496-19dc509699e8	1
283672	citalopram 10 MG Oral Tablet	SCD	16715e29-86e8-48b3-8c12-da70e5893901	1
283672	citalopram 10 MG Oral Tablet	SCD	3993eb55-f0e8-496c-a496-19dc509699e8	1
283672	citalopram 10 MG Oral Tablet	SCD	34d1685a-8e6a-46bc-8977-550979bf4ddd	1
200371	citalopram 20 MG Oral Tablet	SCD	3993eb55-f0e8-496c-a496-19dc509699e8	1
200371	citalopram 20 MG Oral Tablet	SCD	34d1685a-8e6a-46bc-8977-550979bf4ddd	1
200371	citalopram 20 MG Oral Tablet	SCD	16715e29-86e8-48b3-8c12-da70e5893901	1
309314	citalopram 40 MG Oral Tablet	SCD	34d1685a-8e6a-46bc-8977-550979bf4ddd	1
309314	citalopram 40 MG Oral Tablet	SCD	e844a4cf-bbab-21a0-e053-2995a90a1f6c	1
309314	citalopram 40 MG Oral Tablet	SCD	9059c8f1-8755-492d-aba2-5f5088ce69d3	1
309314	citalopram 40 MG Oral Tablet	SCD	b6052b11-a7c1-4f55-8ef5-239541c466ff	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13668-011-01	13668001101	100 TABLET, FILM COATED in 1 BOTTLE (13668-011-01)		2007-10-18	0000-00-00	No	No	Current
13668-011-05	13668001105	500 TABLET, FILM COATED in 1 BOTTLE (13668-011-05)		2007-10-18	0000-00-00	No	No	Current
13668-011-08	13668001108	2800 TABLET, FILM COATED in 1 BOTTLE (13668-011-08)		2007-10-18	0000-00-00	No	No	Current
13668-011-30	13668001130	30 TABLET, FILM COATED in 1 BOTTLE (13668-011-30)		2007-10-18	0000-00-00	No	No	Current
13668-011-74	13668001174	100 TABLET in 1 CARTON (13668-011-74)	100 tablet	2007-10-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Citalopram Hydrobromide	Preferred Pharmaceuticals Inc.	2026-03-30	HUMAN PRESCRIPTION DRUG LABEL	11
Citalopram	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc. \| Piramal Pharma Limited	2026-02-04	HUMAN PRESCRIPTION DRUG LABEL	23
Citalopram	PD-Rx Pharmaceuticals, Inc.	2026-01-05	HUMAN PRESCRIPTION DRUG LABEL	25
Citalopram Hydrobromide	Bryant Ranch Prepack	2024-10-30	HUMAN PRESCRIPTION DRUG LABEL	108
Citalopram Hydrobromide	A-S Medication Solutions	2024-09-18	HUMAN PRESCRIPTION DRUG LABEL	32
Citalopram Tablets, USP	NuCare Pharmaceuticals,Inc.	2024-07-10	HUMAN PRESCRIPTION DRUG LABEL	3
Citalopram Hydrobromide	Northwind Pharmaceuticals, LLC	2024-06-28	HUMAN PRESCRIPTION DRUG LABEL	5
Citalopram Hydrobromide	A-S Medication Solutions	2023-12-26	HUMAN PRESCRIPTION DRUG LABEL	1
Citalopram Hydrobromide	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	8
Citalopram	Direct Rx	2023-04-19	HUMAN PRESCRIPTION DRUG LABEL	5
Citalopram Hydrobromide	Proficient Rx LP	2023-02-01	HUMAN PRESCRIPTION DRUG LABEL	1
Citalopram Hydrobromide	NuCare Pharmaceuticals,Inc.	2022-09-09	HUMAN PRESCRIPTION DRUG LABEL	1
Citalopram Tablets, USP	A-S Medication Solutions	2021-03-01	HUMAN PRESCRIPTION DRUG LABEL	2
Citalopram Tablets, USP	Apotheca Inc.	2016-06-30	HUMAN PRESCRIPTION DRUG LABEL	4
Citalopram Tablets USP	Aidarex Pharmaceuticals LLC	2013-12-17	HUMAN PRESCRIPTION DRUG LABEL	1
Citalopram Tablets USP	Rebel Distributors Corp	2012-01-24	HUMAN PRESCRIPTION DRUG LABEL	1
Citalopram Tablets USP	MedVantx, Inc. \| Torrent Pharmaceuticals Limited \| Blenheim Pharmacal, Inc.	2011-09-22	HUMAN PRESCRIPTION DRUG LABEL	1
Citalopram Tablets USP	Contract Pharmacy Services-PA	2010-07-01	HUMAN PRESCRIPTION DRUG LABEL	1
CITALOPRAM HYDROBROMIDE tablet	Stat Rx USA	2010-06-29	HUMAN PRESCRIPTION DRUG LABEL	2

Citalopram

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#