NDC 0363-1699

Esomeprazole Magnesium

Esomeprazole

Esomeprazole Magnesium is a Oral Capsule, Delayed Release in the Human Otc Drug category. It is labeled and distributed by Walgreen Company. The primary component is Esomeprazole.

Product ID0363-1699_92b2907f-9759-42b4-a0e4-0d1ac7c7a3aa
NDC0363-1699
Product TypeHuman Otc Drug
Proprietary NameEsomeprazole Magnesium
Generic NameEsomeprazole
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2020-03-22
Marketing CategoryANDA / ANDA
Application NumberANDA207193
Labeler NameWalgreen Company
Substance NameESOMEPRAZOLE
Active Ingredient Strength20 mg/1
Pharm ClassesCytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0363-1699-01

1 BOTTLE in 1 CARTON (0363-1699-01) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Marketing Start Date2020-03-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0363-1699-01 [00363169901]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA207193
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-03-22

NDC 0363-1699-03 [00363169903]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA207193
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-03-26

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE20 mg/1

OpenFDA Data

SPL SET ID:29eb7b87-59a4-4d27-ad53-789da7fec427
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 606726