Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
ASCLEMED USA INC. DBA ENOVACHEM
Asclemed USA, Inc.
059888437
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
76420-621Application Number
ANDA207394Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 5, 2023SUCROSEInactive
Code: C151H8M554Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NAClass: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
LansoprazoleActive
Code: 0K5C5T2QPGClass: ACTIBQuantity: 30 mg in 1 1
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT