Omeprazole/Bicarbonate
- Product NDC
- 71205-985
- 11-digit product format
- 712050985
- Labeler code
- 71205
- Product ID
- 71205-985_adaa81e9-047d-486e-aa53-d6cb4e931220
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole and Sodium Bicarbonate
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA207476
- Marketing category
- ANDA
- Marketing start
- 2018-07-27
- Substance
- OMEPRAZOLE; SODIUM BICARBONATE
- Active strength
- 40; 1100 mg/1; mg/1
- Pharmacologic classes
- Alkalinizing Activity [MoA], 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
- Omeprazole/Bicarbonate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OMEPRAZOLE | 40 mg/1 |
| SODIUM BICARBONATE | 1100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KG60484QX9, 8MDF5V39QO |
| Rxcui | 616539, 616541 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71205-985-30 | Omeprazole/Bicarbonate | 30 in 1 BOTTLE, PLASTIC | CAPSULE, GELATIN COATED | 30 | | 3 |
| 71205-985-60 | Omeprazole/Bicarbonate | 60 in 1 BOTTLE, PLASTIC | CAPSULE, GELATIN COATED | 60 | | 3 |
| 71205-985-90 | Omeprazole/Bicarbonate | 90 in 1 BOTTLE, PLASTIC | CAPSULE, GELATIN COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-985 | OMEPRAZOLE/BICARBONATE (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE, GELATIN COATED [PROFICIENT RX LP] | 2 | Current NDC, Legacy NDC, 3 package rows | 20230211_4d642036-7175-4f29-9f07-dbd282231d4a.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 |
|---|
| 71205-985-30 | 71205098530 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (71205-985-30) | 2020-05-01 | 0000-00-00 | No | No | Current |
| 71205-985-60 | 71205098560 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (71205-985-60) | 2020-05-01 | 0000-00-00 | No | No | Current |
| 71205-985-90 | 71205098590 | 90 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (71205-985-90) | 2020-05-01 | 0000-00-00 | No | No | Current |