Omeprazole
- Product NDC
- 51655-452
- 11-digit product format
- 516550452
- Labeler code
- 51655
- Product ID
- 51655-452_4b44baf6-9a17-c928-e063-6294a90a884e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA203270
- Marketing category
- ANDA
- Marketing start
- 2022-09-26
- Substance
- OMEPRAZOLE
- Active strength
- 40 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 | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KG60484QX9 |
| Rxcui | 200329 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-452-25 | Omeprazole | 60 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 60 | | 4 |
| 51655-452-26 | Omeprazole | 90 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-452 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC] | 2 | Current NDC, 2 package rows | 20240723_f3038133-8bb2-044e-e053-2995a90a6e7d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-452-25 | 51655045225 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-452-25) | 2023-02-02 | No | No | Historical |
| 51655-452-26 | 51655045226 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-452-26) | 2022-09-26 | No | No | Historical |