Omeprazole Magnesium
- Product NDC
- 53943-520
- 11-digit product format
- 539430520
- Labeler code
- 53943
- Product ID
- 53943-520_c037b256-364d-d0fb-5d88-53d0f628d168
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Omeprazole Magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Discount Drug Mart, Inc
- Application
- ANDA078878
- Marketing category
- ANDA
- Marketing start
- 2016-11-18
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53943-520 | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DISCOUNT DRUG MART, INC] | 3 | Current NDC, Legacy NDC | 20241112_daeeba93-29d5-efb4-a591-3e72c4e50341.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53943-520-14 | 53943052014 | 1 BOTTLE in 1 CARTON (53943-520-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2016-11-18 | 0000-00-00 | No | No | Current |
| 53943-520-42 | 53943052042 | 3 BOTTLE in 1 CARTON (53943-520-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2016-11-18 | 0000-00-00 | No | No | Current |