OMEPRAZOLE
- Product NDC
- 46122-686
- 11-digit product format
- 461220686
- Labeler code
- 46122
- Product ID
- 46122-686_47dce86f-d184-44cf-8ee3-18dad7f401b8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- OMEPRAZOLE
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- AMERISOURCE BERGEN
- Application
- ANDA210593
- Marketing category
- ANDA
- Marketing start
- 2021-03-31
- Substance
- OMEPRAZOLE MAGNESIUM
- Active strength
- 20.6 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 MAGNESIUM | 20.6 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 |
|---|
| 46122-686-03 | OMEPRAZOLE | 2 in 1 BLISTER PACK | CAPSULE, DELAYED RELEASE | 2 | | 1 |
| 46122-686-74 | OMEPRAZOLE | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46122-686 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERISOURCE BERGEN] | 1 | Current NDC, Legacy NDC, 2 package rows | 20210401_47dce86f-d184-44cf-8ee3-18dad7f401b8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 46122-686-03 | 46122068603 | 2 BOTTLE in 1 BLISTER PACK (46122-686-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46122-686-74) | 2 bottle | 2021-03-31 | 0000-00-00 | No | No | Current |
| 46122-686-74 | 46122068674 | 14 in 1 BOTTLE | | | | | | Historical |