LYVISPAH

Product NDC
64896-076
11-digit product format
648960076
Labeler code
64896
Product ID
64896-076_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
5 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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
H789N3FKE8BACLOFEN1134-47-0BACLOFEN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64896-076-096489600760990 PACKET in 1 CARTON (64896-076-09) / 1 GRANULE in 1 PACKET90 packet2023-06-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
LYVISPAH - Amneal Pharmaceuticals LLCAmneal Pharmaceuticals LLC2023-04-23HUMAN PRESCRIPTION DRUG LABEL5