Omeprazole
- Product NDC
- 82804-166
- 11-digit product format
- 828040166
- Labeler code
- 82804
- Product ID
- 82804-166_ee0598a1-0e5e-40ff-ad88-b0adfc533ca0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA075757
- Marketing category
- ANDA
- Marketing start
- 2019-07-01
- Substance
- OMEPRAZOLE
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KG60484QX9 |
| Rxcui | 199119 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-166-60 | Omeprazole | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-166 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 1 | Current NDC, 1 package rows | 20241222_ee0598a1-0e5e-40ff-ad88-b0adfc533ca0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-166-60 | 82804016660 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82804-166-60) | 2024-12-16 | No | No | Current |