Omeprazole

Product NDC
50090-7021
11-digit product format
500907021
Labeler code
50090
Product ID
50090-7021_0808f50f-ad4b-44e2-a872-4dfa526fe6dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091352
Marketing category
ANDA
Marketing start
2012-11-23
Substance
OMEPRAZOLE
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
KG60484QX9OMEPRAZOLE73590-58-6OMEPRAZOLE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7021-050090702100100 BLISTER PACK in 1 CARTON (50090-7021-0) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK100 blister pack2024-01-04NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OmeprazoleA-S Medication Solutions2024-02-27HUMAN PRESCRIPTION DRUG LABEL7