Omeprazole
- Product NDC
- 63187-805
- 11-digit product format
- 631870805
- Labeler code
- 63187
- Product ID
- 63187-805_cc7a83fe-a933-4a9a-b6ac-a2b1d85cdeb1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA075576
- Marketing category
- ANDA
- Marketing start
- 2009-01-21
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-805-60 | Omeprazole | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | | 6 |
| 63187-805-90 | Omeprazole | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-805 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241204_f0f61a89-700d-481d-9255-6f9a9afa7025.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 |
|---|
| 63187-805-30 | 63187080530 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-805-30) | 2017-01-02 | 0000-00-00 | No | No | Current |
| 63187-805-60 | 63187080560 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-805-60) | 2017-01-02 | 0000-00-00 | No | No | Current |
| 63187-805-90 | 63187080590 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-805-90) | 2017-01-02 | 0000-00-00 | No | No | Current |