Omeprazole
- Product NDC
- 71335-1851
- 11-digit product format
- 713351851
- Labeler code
- 71335
- Product ID
- 71335-1851_ef9510bf-050b-44e7-a6bc-5b913f9025ce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA203270
- Marketing category
- ANDA
- Marketing start
- 2015-08-19
- Substance
- OMEPRAZOLE
- Active strength
- 40 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Omeprazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OMEPRAZOLE | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KG60484QX9 |
| Rxcui | 200329 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1851-1 | 71335185101 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1851-1) | 2021-05-19 | 0000-00-00 | No | No | Current |
| 71335-1851-2 | 71335185102 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1851-2) | 2021-05-19 | 0000-00-00 | No | No | Current |
| 71335-1851-3 | 71335185103 | 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1851-3) | 2024-12-11 | 0000-00-00 | No | No | Current |
| 71335-1851-4 | 71335185104 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1851-4) | 2021-05-20 | 0000-00-00 | No | No | Current |
| 71335-1851-5 | 71335185105 | 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1851-5) | 2021-06-07 | 0000-00-00 | No | No | Current |
| 71335-1851-6 | 71335185106 | 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1851-6) | 2024-12-11 | 0000-00-00 | No | No | Current |
| 71335-1851-7 | 71335185107 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1851-7) | 2024-12-11 | 0000-00-00 | No | No | Current |
| 71335-1851-8 | 71335185108 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1851-8) | 2024-12-11 | 0000-00-00 | No | No | Current |