Sevelamer Carbonate
- Product NDC
- 69452-126
- 11-digit product format
- 694520126
- Labeler code
- 69452
- Product ID
- 69452-126_204ad91c-58e0-5be6-e063-6294a90a5574
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sevelamer Carbonate
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- ANDA209374
- Marketing category
- ANDA
- Marketing start
- 2021-09-01
- Substance
- SEVELAMER CARBONATE
- Active strength
- 800 mg/1
- Pharmacologic classes
- Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sevelamer Carbonate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SEVELAMER CARBONATE | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9YCX42I8IU |
| Rxcui | 861370, 861375 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69452-126-19 | Sevelamer Carbonate | 90 in 1 CARTON | POWDER, FOR SUSPENSION | 90 | | 3 |
| 69452-126-60 | Sevelamer Carbonate | 1 in 1 PACKET | POWDER, FOR SUSPENSION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69452-126 | SEVELAMER CARBONATE POWDER, FOR SUSPENSION [BIONPHARMA INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240823_c3cf4807-ae5f-528e-e053-2a95a90ac640.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 |
|---|
| 69452-126-19 | 69452012619 | 90 PACKET in 1 CARTON (69452-126-19) / 1 POWDER, FOR SUSPENSION in 1 PACKET (69452-126-60) | 90 packet | 2021-10-01 | 0000-00-00 | No | No | Current |
| 69452-126-60 | 69452012660 | 1 in 1 PACKET | | | | | | Historical |