LYVISPAH

Product NDC: 64896-078
11-digit product format: 648960078
Labeler code: 64896
Product ID: 64896-078_d042d45f-7097-47e0-921f-0442e00d47e0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: baclofen
Dosage form: GRANULE
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: NDA215422
Marketing category: NDA
Marketing start: 2023-06-01
Substance: BACLOFEN
Active strength: 20 mg/1
Pharmacologic classes: GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 64896-078_d042d45f-7097-47e0-921f-0442e00d47e0
SPL ID: d042d45f-7097-47e0-921f-0442e00d47e0
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: LYVISPAH
Generic name: baclofen
Dosage form: GRANULE
Route: ORAL
Marketing start: 2023-06-01
Marketing category: NDA
Application number: NDA215422
Pharmacologic classes: GABA A Agonists [MoA]; GABA B Agonists [MoA]; gamma-Aminobutyric Acid-ergic Agonist [EPC]
Listing expiration: 2026-12-31

Ingredient	Strength
BACLOFEN	20 mg/1

Package NDC	Description	Marketing start	Sample
64896-078-09	90 PACKET in 1 CARTON (64896-078-09) / 1 GRANULE in 1 PACKET	2023-06-01	No

UNII	Preferred term	Registry number	Matched term
H789N3FKE8	BACLOFEN	1134-47-0	BACLOFEN

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
64896-078-09	64896007809	90 PACKET in 1 CARTON (64896-078-09) / 1 GRANULE in 1 PACKET	90 packet	2023-06-01	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
LYVISPAH - Amneal Pharmaceuticals LLC	Amneal Pharmaceuticals LLC	2023-04-23	HUMAN PRESCRIPTION DRUG LABEL	5