Omeprazole
- Product NDC
- 42708-159
- 11-digit product format
- 427080159
- Labeler code
- 42708
- Product ID
- 42708-159_459bdb99-6d60-3b98-e063-6294a90a57b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- QPharma, Inc.
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42708-159-14 | Omeprazole | 14 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 14 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42708-159 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [QPHARMA, INC.] | 3 | Current NDC, 1 package rows | 20241123_f5dd5d63-1376-1ff7-e053-2a95a90a1d94.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42708-159-14 | 42708015914 | 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42708-159-14) | 2023-03-01 | Yes | No | Current |