Omeprazole
- Product NDC
- 58602-837
- 11-digit product format
- 586020837
- Labeler code
- 58602
- Product ID
- 58602-837_0c2600f3-e9de-4e73-8ee1-9aeb94d228e4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- ANDA213201
- Marketing category
- ANDA
- Marketing start
- 2023-04-28
- 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 |
|---|
| 58602-837-05 | Omeprazole | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | | 2 |
| 58602-837-05 | Omeprazole | 1 in 1 CARTON | CAPSULE, DELAYED RELEASE | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58602-837 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROHEALTH LLC] | 2 | Current NDC, 2 package rows | 20240222_19097902-a5e6-423a-8569-31c569cd3cdb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58602-837-05 | 58602083705 | 1 BOTTLE in 1 CARTON (58602-837-05) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2023-04-28 | No | No | Historical |