Omeprazole and Sodium Bicarbonate
- Product NDC
- 13107-115
- 11-digit product format
- 131070115
- Labeler code
- 13107
- Product ID
- 13107-115_24a89440-1995-44fc-b739-8c9f666efdb5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole and Sodium Bicarbonate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aurolife Pharma, LLC
- Application
- ANDA204922
- Marketing category
- ANDA
- Marketing start
- 2014-09-30
- Marketing end
- 0000-00-00
- Substance
- OMEPRAZOLE; SODIUM BICARBONATE
- Active strength
- 20 mg/1; mg/1
- Pharmacologic classes
- Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13107-115-05 | Omeprazole and Sodium Bicarbonate | 500 in 1 BOTTLE | CAPSULE | 500 | | 3 |
| 13107-115-30 | Omeprazole and Sodium Bicarbonate | 30 in 1 BOTTLE | CAPSULE | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13107-115 | OMEPRAZOLE AND SODIUM BICARBONATE CAPSULE [AUROLIFE PHARMA, LLC] | 3 | Legacy NDC, 2 package rows | 20190912_1e3a3321-fd27-4b56-8690-933d0c8738b9.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 |
|---|
| 13107-115-05 | 13107011505 | 500 CAPSULE in 1 BOTTLE (13107-115-05) | 500 capsule | 2014-09-30 | 0000-00-00 | No | No | Current |
| 13107-115-30 | 13107011530 | 30 CAPSULE in 1 BOTTLE (13107-115-30) | 30 capsule | 2014-09-30 | 0000-00-00 | No | No | Current |