SOLIFENACIN SUCCINATE

Product NDC: 71335-2423
11-digit product format: 713352423
Labeler code: 71335
Product ID: 71335-2423_615305a0-25db-4e41-a63c-d00d0f5abd95
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SOLIFENACIN SUCCINATE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA211657
Marketing category: ANDA
Marketing start: 2019-05-20
Substance: SOLIFENACIN SUCCINATE
Active strength: 5 mg/1
Pharmacologic classes: Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 71335-2423_615305a0-25db-4e41-a63c-d00d0f5abd95
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: SOLIFENACIN SUCCINATE
Generic name: SOLIFENACIN SUCCINATE
Dosage form: TABLET, FILM COATED
Route: ORAL
Marketing start: 2019-05-20
Marketing category: ANDA
Application number: ANDA211657
Pharmacologic classes: Cholinergic Muscarinic Antagonist [EPC]; Cholinergic Muscarinic Antagonists [MoA]
Listing expiration: 2026-12-31

Ingredient	Strength
SOLIFENACIN SUCCINATE	5 mg/1

UNII	Preferred term	Registry number	Matched term
KKA5DLD701	SOLIFENACIN SUCCINATE	242478-38-2	SOLIFENACIN SUCCINATE

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-2423-1	71335242301	30 TABLET, FILM COATED in 1 BOTTLE (71335-2423-1)	2024-07-01	No	No	Current
71335-2423-2	71335242302	90 TABLET, FILM COATED in 1 BOTTLE (71335-2423-2)	2024-07-01	No	No	Current

Title	Manufacturer	Effective date	Type	Version
SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	2024-07-01	HUMAN PRESCRIPTION DRUG LABEL	1