sevelamer carbonate
- Product NDC
- 0115-1365
- 11-digit product format
- 001151365
- Labeler code
- 0115
- Product ID
- 0115-1365_b673720f-b62b-4afc-ac25-cb2ac4cf326f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sevelamer carbonate
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA211316
- Marketing category
- ANDA
- Marketing start
- 2020-11-20
- 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 |
|---|
| 0115-1365-29 | sevelamer carbonate | 90 in 1 CARTON | POWDER, FOR SUSPENSION | 90 | | 11 |
| 0115-1365-30 | sevelamer carbonate | 1 in 1 PACKET | POWDER, FOR SUSPENSION | 1 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0115-1365 | SEVELAMER CARBONATE POWDER, FOR SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240101_da5239fe-060b-4469-95ac-173adec43b9c.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 |
|---|
| 0115-1365-29 | 00115136529 | 90 PACKET in 1 CARTON (0115-1365-29) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0115-1365-30) | 90 packet | 2020-11-20 | 0000-00-00 | No | No | Current |
| 0115-1365-30 | 00115136530 | 1 in 1 PACKET | | | | | | Historical |