Sevelamer Carbonate
- Product NDC
- 0615-8239
- 11-digit product format
- 006158239
- Labeler code
- 0615
- Product ID
- 0615-8239_058c3f14-09d3-4075-a066-6294fc7139c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sevelamer Carbonate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA207179
- Marketing category
- ANDA
- Marketing start
- 2017-07-17
- 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 | 749206 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8239-05 | Sevelamer Carbonate | 15 in 1 BLISTER PACK | TABLET, FILM COATED | 15 | | 11 |
| 0615-8239-39 | Sevelamer Carbonate | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8239 | SEVELAMER CARBONATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240815_ccfde4dd-b258-4baf-995b-a24bed8c84d7.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 |
|---|
| 0615-8239-05 | 00615823905 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8239-05) | 2024-07-15 | | No | No | Historical |
| 0615-8239-39 | 00615823939 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8239-39) | 2018-11-06 | 0000-00-00 | No | No | Current |