Sevelamer carbonate
- Product NDC
- 68382-824
- 11-digit product format
- 683820824
- Labeler code
- 68382
- Product ID
- 68382-824_c36f7488-a329-4113-8027-dfc92bbc6bbc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sevelamer carbonate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA207759
- Marketing category
- ANDA
- Marketing start
- 2020-09-17
- 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 |
|---|
| 68382-824-10 | Sevelamer carbonate | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 3 |
| 68382-824-27 | Sevelamer carbonate | 270 in 1 BOTTLE | TABLET, FILM COATED | 270 | | 3 |
| 68382-824-30 | Sevelamer carbonate | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 3 |
| 68382-824-77 | Sevelamer carbonate | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-824 | SEVELAMER CARBONATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] | 3 | Current NDC, Legacy NDC, 4 package rows | 20231110_71f61492-8971-424a-8415-dfd2e15d05d9.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 |
|---|
| 68382-824-10 | 68382082410 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-824-10) | | 2020-09-17 | 0000-00-00 | No | No | Current |
| 68382-824-27 | 68382082427 | 270 TABLET, FILM COATED in 1 BOTTLE (68382-824-27) | | 2020-09-17 | 0000-00-00 | No | No | Current |
| 68382-824-30 | 68382082430 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 68382-824-77 | 68382082477 | 10 BLISTER PACK in 1 CARTON (68382-824-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-824-30) | 10 blister pack | 2020-09-17 | 0000-00-00 | No | No | Current |