Omeprazole
- Product NDC
- 70518-1019
- 11-digit product format
- 705181019
- Labeler code
- 70518
- Product ID
- 70518-1019_8fe6cbc3-b905-19b7-e053-2995a90a7d8f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA075757
- Marketing category
- ANDA
- Marketing start
- 2018-02-16
- Marketing end
- 0000-00-00
- Substance
- OMEPRAZOLE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record