VARDENAFIL HYDROCHLORIDE

Product NDC: 71335-2357
11-digit product format: 713352357
Labeler code: 71335
Product ID: 71335-2357_d372a596-aa3a-4bd7-b311-ee32b051d758
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: VARDENAFIL HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA214031
Marketing category: ANDA
Marketing start: 2020-08-05
Substance: VARDENAFIL HYDROCHLORIDE
Active strength: 20 mg/1
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 71335-2357_d372a596-aa3a-4bd7-b311-ee32b051d758
SPL ID: d372a596-aa3a-4bd7-b311-ee32b051d758
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: VARDENAFIL HYDROCHLORIDE
Generic name: VARDENAFIL HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Marketing start: 2020-08-05
Marketing category: ANDA
Application number: ANDA214031
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC]; Phosphodiesterase 5 Inhibitors [MoA]
Listing expiration: 2026-12-31

Ingredient	Strength
VARDENAFIL HYDROCHLORIDE	20 mg/1

Package NDC	Description	Marketing start	Sample
71335-2357-1	30 TABLET, FILM COATED in 1 BOTTLE (71335-2357-1)	2024-05-28	No

UNII	Preferred term	Registry number	Matched term
5M8S2CU0TS	VARDENAFIL HYDROCHLORIDE	330808-88-3	VARDENAFIL HYDROCHLORIDE

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-2357-1	71335235701	30 TABLET, FILM COATED in 1 BOTTLE (71335-2357-1)	2024-05-28	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
VARDENAFIL HYDROCHLORIDE	Bryant Ranch Prepack	2024-05-28	HUMAN PRESCRIPTION DRUG LABEL	1