Omeprazole
- Product NDC
- 71335-1191
- 11-digit product format
- 713351191
- Labeler code
- 71335
- Product ID
- 71335-1191_785ad3a1-f8c9-4a0d-82b5-5ae9cd6d10b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA091672
- Marketing category
- ANDA
- Marketing start
- 2014-10-31
- 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
- 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KG60484QX9 |
| Rxcui | 199119 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-1191-1 | Omeprazole | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | | 102 |
| 71335-1191-2 | Omeprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 102 |
| 71335-1191-3 | Omeprazole | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 102 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1191 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK] | 102 | Current NDC, Legacy NDC, 3 package rows | 20240522_f1e47c7a-73a0-49a5-9e17-f863af7b07a1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1191-1 | 71335119101 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1191-1) | 2019-04-18 | 0000-00-00 | No | No | Current |
| 71335-1191-2 | 71335119102 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1191-2) | 2024-05-17 | 0000-00-00 | No | No | Current |
| 71335-1191-3 | 71335119103 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1191-3) | 2024-05-17 | 0000-00-00 | No | No | Current |