Acid Reducer
- Product NDC
- 0536-1322
- 11-digit product format
- 005361322
- Labeler code
- 0536
- Product ID
- 0536-1322_6616864c-9739-4e69-86a1-29c07441f9ba
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Rugby Laboratories
- Application
- ANDA206877
- Marketing category
- ANDA
- Marketing start
- 2020-09-15
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Acid Reducer
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OMEPRAZOLE MAGNESIUM | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 426QFE7XLK |
| Rxcui | 402014 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0536-1322-13 | Acid Reducer | 14 in 1 BOTTLE | TABLET, DELAYED RELEASE | 14 | | 5 |
| 0536-1322-13 | Acid Reducer | 3 in 1 CARTON | TABLET, DELAYED RELEASE | 3 | | 5 |
| 0536-1322-71 | Acid Reducer | 2 in 1 CARTON | TABLET, DELAYED RELEASE | 2 | | 5 |
| 0536-1322-71 | Acid Reducer | 14 in 1 BOTTLE | TABLET, DELAYED RELEASE | 14 | | 5 |
| 0536-1322-88 | Acid Reducer | 1 in 1 CARTON | TABLET, DELAYED RELEASE | 1 | | 5 |
| 0536-1322-88 | Acid Reducer | 14 in 1 BOTTLE | TABLET, DELAYED RELEASE | 14 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0536-1322 | ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [RUGBY LABORATORIES] | 4 | Current NDC, Legacy NDC, 6 package rows | 20240618_33990795-e994-4307-a570-9e8e8b44c473.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 |
|---|
| 0536-1322-13 | 00536132213 | 3 BOTTLE in 1 CARTON (0536-1322-13) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2020-09-15 | 0000-00-00 | No | No | Current |
| 0536-1322-71 | 00536132271 | 2 BOTTLE in 1 CARTON (0536-1322-71) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | 2 bottle | 2020-09-15 | 0000-00-00 | No | No | Current |
| 0536-1322-88 | 00536132288 | 1 BOTTLE in 1 CARTON (0536-1322-88) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2020-09-15 | 0000-00-00 | No | No | Current |