Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
A-S Medication Solutions
A-S Medication Solutions
830016429
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LANSOPRAZOLE
Product Details
NDC Product Code
50090-2225Application Number
ANDA201921Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 30, 2019LansoprazoleActive
Code: 0K5C5T2QPGClass: ACTIBQuantity: 30 mg in 1 1
ACETONEInactive
Code: 1364PS73AFClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NAClass: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT