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FDA Approval

Lansoprazole

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
November 17, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Lansoprazole(15 mg in 1 1)

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
50090-6079
Application Number
ANDA205868
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 28, 2022
MAGNESIUM CARBONATEInactive
Code: 0E53J927NAClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
Code: 0K5C5T2QPGClass: ACTIBQuantity: 15 mg in 1 1
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