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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 9YCX42I8IU | SEVELAMER CARBONATE | 845273-93-0 | SEVELAMER CARBONATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68382-824-10 | 68382082410 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-824-10) | | 2020-09-17 | No | No | Historical |
| 68382-824-27 | 68382082427 | 270 TABLET, FILM COATED in 1 BOTTLE (68382-824-27) | | 2020-09-17 | No | No | 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 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Sevelamer carbonate | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2023-11-07 | HUMAN PRESCRIPTION DRUG LABEL | 3 |