Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aphena Pharma Solutions - Tennessee, LLC
Aphena Pharma Solutions - Tennessee, LLC
128385585
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Gabapentin
Product Details
NDC Product Code
71610-198Application Number
ANDA204989Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 29, 2021TALCInactive
Code: 7SEV7J4R1UClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
GabapentinActive
Code: 6CW7F3G59XClass: ACTIBQuantity: 400 mg in 1 1
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT