omeprazole
- Product NDC
- 31722-528
- 11-digit product format
- 317220528
- Labeler code
- 31722
- Product ID
- 31722-528_2b439e93-9a24-e64a-e063-6394a90a634f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA204012
- Marketing category
- ANDA
- Marketing start
- 2019-09-26
- Substance
- OMEPRAZOLE
- Active strength
- 20 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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KG60484QX9 |
| Rxcui | 198051, 199119 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-528-01 | omeprazole | 100 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 100 | | 2 |
| 31722-528-30 | omeprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-528 | OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20250110_0c6e00a2-31e8-4e84-928d-80e69a5fc634.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 |
|---|
| 31722-528-01 | 31722052801 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-528-01) | 2019-09-26 | 0000-00-00 | No | No | Current |
| 31722-528-30 | 31722052830 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-528-30) | 2019-09-26 | 0000-00-00 | No | No | Current |