Omeprazole
- Product NDC
- 51655-061
- 11-digit product format
- 516550061
- Labeler code
- 51655
- Product ID
- 51655-061_46ddc2ac-c491-4747-e063-6294a90a8c56
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA075576
- Marketing category
- ANDA
- Marketing start
- 2020-06-01
- 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
- 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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KG60484QX9 |
| Rxcui | 198051 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-061-25 | Omeprazole | 60 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 60 | | 6 |
| 51655-061-26 | Omeprazole | 90 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 90 | | 6 |
| 51655-061-52 | Omeprazole | 30 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-061 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC] | 5 | Current NDC, Legacy NDC, 3 package rows | 20240726_aae3bf9f-5d05-889f-e053-2995a90a5ff2.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 |
|---|
| 51655-061-25 | 51655006125 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-061-25) | 2020-06-01 | 0000-00-00 | No | No | Current |
| 51655-061-26 | 51655006126 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-061-26) | 2024-01-25 | | No | No | Current |
| 51655-061-52 | 51655006152 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-061-52) | 2020-06-01 | 0000-00-00 | No | No | Current |