OMEPRAZOLE
- Product NDC
- 51316-843
- 11-digit product format
- 513160843
- Labeler code
- 51316
- Product ID
- 51316-843_2480bbfc-d4fe-4d52-b9a6-48c9f4fe9698
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- Application
- ANDA216096
- Marketing category
- ANDA
- Marketing start
- 2026-02-06
- Substance
- OMEPRAZOLE MAGNESIUM
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OMEPRAZOLE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OMEPRAZOLE MAGNESIUM | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 426QFE7XLK |
| Rxcui | 198051 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51316-843-01 | OMEPRAZOLE | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | | 3 |
| 51316-843-03 | OMEPRAZOLE | 3 in 1 CARTON | CAPSULE, DELAYED RELEASE | 3 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51316-843-01 | 51316084301 | 14 in 1 BOTTLE | | | | | Historical |
| 51316-843-03 | 51316084303 | 3 BOTTLE in 1 CARTON (51316-843-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51316-843-01) | 3 bottle | 2026-02-06 | No | No | Current |