Citalopram Hydrobromide

Product NDC: 68071-2459
11-digit product format: 680712459
Labeler code: 68071
Product ID: 68071-2459_2c6523b5-e13b-51f9-e063-6394a90a2f84
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Citalopram Hydrobromide
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA078216
Marketing category: ANDA
Marketing start: 2007-10-18
Substance: CITALOPRAM HYDROBROMIDE
Active strength: 10 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

openFDA Listing Details

Product ID: 68071-2459_2c6523b5-e13b-51f9-e063-6394a90a2f84
SPL ID: 2c6523b5-e13b-51f9-e063-6394a90a2f84
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Citalopram Hydrobromide
Generic name: Citalopram Hydrobromide
Dosage form: TABLET
Route: ORAL
Marketing start: 2007-10-18
Marketing category: ANDA
Application number: ANDA078216
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC]; Serotonin Uptake Inhibitors [MoA]
Listing expiration: 2026-12-31

Ingredient	Strength
CITALOPRAM HYDROBROMIDE	10 mg/1

Package NDC	Description	Marketing start	Sample
68071-2459-1	100 TABLET in 1 BOTTLE (68071-2459-1)	2021-06-24	No

UNII	Preferred term	Registry number	Matched term
I1E9D14F36	CITALOPRAM HYDROBROMIDE	59729-32-7	CITALOPRAM HYDROBROMIDE

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-2459-1	68071245901	100 TABLET in 1 BOTTLE (68071-2459-1)	100 tablet	2021-06-24	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Citalopram Tablets, USP	NuCare Pharmaceuticals,Inc.	2025-01-23	HUMAN PRESCRIPTION DRUG LABEL	2