Omeprazole
- Product NDC
- 0363-9980
- 11-digit product format
- 003639980
- Labeler code
- 0363
- Product ID
- 0363-9980_8add376a-81a3-41e0-ba8d-037f7f56165a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- OMEPRAZOLE MAGNESIUM
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Walgreen Company
- Application
- ANDA210593
- Marketing category
- ANDA
- Marketing start
- 2021-01-05
- 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
- 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 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 |
|---|
| 0363-9980-14 | Omeprazole | 1 in 1 CARTON | CAPSULE, DELAYED RELEASE | 1 | | 3 |
| 0363-9980-14 | Omeprazole | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | | 3 |
| 0363-9980-28 | Omeprazole | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | | 3 |
| 0363-9980-28 | Omeprazole | 2 in 1 CARTON | CAPSULE, DELAYED RELEASE | 2 | | 3 |
| 0363-9980-42 | Omeprazole | 3 in 1 CARTON | CAPSULE, DELAYED RELEASE | 3 | | 3 |
| 0363-9980-42 | Omeprazole | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0363-9980 | OMEPRAZOLE (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [WALGREEN COMPANY] | 3 | Current NDC, Legacy NDC, 6 package rows | 20211207_537b9a46-ecc8-4537-9657-c9ff7821dd4b.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 |
|---|
| 0363-9980-14 | 00363998014 | 1 BOTTLE in 1 CARTON (0363-9980-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2021-01-05 | 0000-00-00 | No | No | Current |
| 0363-9980-28 | 00363998028 | 2 BOTTLE in 1 CARTON (0363-9980-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 2 bottle | 2021-01-05 | 0000-00-00 | No | No | Current |
| 0363-9980-42 | 00363998042 | 3 BOTTLE in 1 CARTON (0363-9980-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2021-01-05 | 0000-00-00 | No | No | Current |