Omeprazole
- Product NDC
- 16714-630
- 11-digit product format
- 167140630
- Labeler code
- 16714
- Product ID
- 16714-630_fe36a9a7-13d0-f4f1-1e31-b35cf651b79d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA078490
- Marketing category
- ANDA
- Marketing start
- 2026-03-01
- Substance
- OMEPRAZOLE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| KG60484QX9 | OMEPRAZOLE | 73590-58-6 | OMEPRAZOLE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 16714-630-01 | 16714063001 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-630-01) | 2026-03-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Omeprazole | NorthStar Rx LLC | Dr. Reddy's Laboratories Limited- FTO3 | 2026-03-02 | HUMAN PRESCRIPTION DRUG LABEL | 6 |