Omeprazole Magnesium
- Product NDC
- 83324-117
- 11-digit product format
- 833240117
- Labeler code
- 83324
- Product ID
- 83324-117_4dc933e8-453c-ce09-f473-879ff3407e05
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Omeprazole Magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Chain Drug Marketing Association
- Application
- ANDA078878
- Marketing category
- ANDA
- Marketing start
- 2016-01-01
- 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 Magnesium
- 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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83324-117 | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION] | 3 | Current NDC | 20241112_ab5d339b-2c02-611d-d5db-8e1891684fe0.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 |
|---|
| 83324-117-14 | 83324011714 | 1 BOTTLE in 1 CARTON (83324-117-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2024-11-01 | No | No | Historical |
| 83324-117-42 | 83324011742 | 3 BOTTLE in 1 CARTON (83324-117-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2024-11-01 | No | No | Historical |