Esomeprazole Magnesium

Product NDC
83324-200
11-digit product format
833240200
Labeler code
83324
Product ID
83324-200_9d8226fd-2837-05c9-26da-5b1e5568561e
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION, INC.
Application
ANDA207198
Marketing category
ANDA
Marketing start
2025-03-01
Substance
ESOMEPRAZOLE MAGNESIUM
Active strength
20 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
R6DXU4WAY9ESOMEPRAZOLE MAGNESIUM217087-09-7ESOMEPRAZOLE MAGNESIUM

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-200-14833240200141 BOTTLE in 1 CARTON (83324-200-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2025-03-01NoNoHistorical
83324-200-42833240200423 BOTTLE in 1 CARTON (83324-200-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2025-03-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Drug FactsCHAIN DRUG MARKETING ASSOCIATION, INC.2025-10-28HUMAN OTC DRUG LABEL3
Drug FactsCHAIN DRUG MARKETING ASSOCIATION, INC.2024-10-23HUMAN OTC DRUG LABEL2