omeprazole sodium bicarbonate
- Product NDC
- 69097-913
- 11-digit product format
- 690970913
- Labeler code
- 69097
- Product ID
- 69097-913_d7eae0fc-9dfd-48d5-9491-e785fd66d5ec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omeprazole sodium bicarbonate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA207476
- Marketing category
- ANDA
- Marketing start
- 2017-01-30
- Substance
- OMEPRAZOLE; SODIUM BICARBONATE
- Active strength
- 20; 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- omeprazole sodium bicarbonate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OMEPRAZOLE | 20 mg/1 |
| SODIUM BICARBONATE | 1100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8MDF5V39QO, KG60484QX9 |
| Rxcui | 616539, 616541 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69097-913-02 | omeprazole sodium bicarbonate | 30 in 1 BOTTLE | CAPSULE | 30 | | 8 |
| 69097-913-12 | omeprazole sodium bicarbonate | 500 in 1 BOTTLE | CAPSULE | 500 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-913 | OMEPRAZOLE SODIUM BICARBONATE CAPSULE [CIPLA USA INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20231223_9cdde58a-ae8a-451f-92cf-cab178e4ba92.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 |
|---|
| 69097-913-02 | 69097091302 | 30 CAPSULE in 1 BOTTLE (69097-913-02) | 30 capsule | 2017-01-30 | 0000-00-00 | No | No | Current |
| 69097-913-12 | 69097091312 | 500 CAPSULE in 1 BOTTLE (69097-913-12) | 500 capsule | 2017-01-30 | 0000-00-00 | No | No | Current |