Omeprazole

Product NDC
50090-7213
11-digit product format
500907213
Labeler code
50090
Product ID
50090-7213_dcc5042d-84f2-4618-bcd1-61574c6764f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203270
Marketing category
ANDA
Marketing start
2015-08-19
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 formatDescriptionMarketing startSampleExclude flagStatus
50090-7213-05009072130030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7213-0) 2024-08-06NoNoHistorical
50090-7213-25009072130215 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7213-2) 2024-08-06NoNoHistorical
50090-7213-35009072130360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7213-3) 2024-08-06NoNoHistorical
50090-7213-45009072130420 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7213-4) 2024-08-06NoNoHistorical
50090-7213-55009072130590 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7213-5) 2024-08-06NoNoHistorical
50090-7213-650090721306200 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7213-6) 2024-08-06NoNoHistorical
50090-7213-750090721307180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7213-7) 2024-08-06NoNoHistorical
50090-7213-8500907213087 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7213-8) 2024-08-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OmeprazoleA-S Medication Solutions2024-08-08Human Prescription Drug Label1