Omeprazole
- Product NDC
- 82009-022
- 11-digit product format
- 820090022
- Labeler code
- 82009
- Product ID
- 82009-022_17380ad5-9506-8e44-aa84-b6ce52ac7b9b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Quallent Pharmaceuticals Health LLC
- Application
- ANDA075576
- Marketing category
- ANDA
- Marketing start
- 2022-11-15
- Marketing end
- 2028-08-30
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Omeprazole
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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82009-022-10 | Omeprazole | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 1000 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82009-022 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [QUALLENT PHARMACEUTICALS HEALTH LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20231006_665e9877-85ac-fdb6-54ac-1c47941ceab8.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 |
|---|
| 82009-022-10 | 82009002210 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-022-10) | 2022-11-15 | 2028-08-30 | No | No | Current |