Solifenacin Succinate

Product NDC: 71205-559
11-digit product format: 712050559
Labeler code: 71205
Product ID: 71205-559_d6525817-bea1-4a4c-bed4-4873ee202cc8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Solifenacin Succinate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA209333
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: 71205-559_d6525817-bea1-4a4c-bed4-4873ee202cc8
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: ANDA209333
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	Marketing end	Sample	Exclude flag	Status
71205-559-30	71205055930	30 TABLET, FILM COATED in 1 BOTTLE (71205-559-30)	2021-05-05	0000-00-00	No	No	Current
71205-559-60	71205055960	60 TABLET, FILM COATED in 1 BOTTLE (71205-559-60)	2021-05-05	0000-00-00	No	No	Current
71205-559-90	71205055990	90 TABLET, FILM COATED in 1 BOTTLE (71205-559-90)	2021-05-05	0000-00-00	No	No	Current

Title	Manufacturer	Effective date	Type	Version
Solifenacin Succinate	Proficient Rx LP	2021-05-01	HUMAN PRESCRIPTION DRUG LABEL	1