sevelamer carbonate

Generic: sevelamer carbonate

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sevelamer carbonate
Generic Name sevelamer carbonate
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sevelamer carbonate 800 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-824
Product ID 68382-824_c36f7488-a329-4113-8027-dfc92bbc6bbc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207759
Listing Expiration 2026-12-31
Marketing Start 2020-09-17

Pharmacologic Class

Classes
phosphate binder [epc] phosphate chelating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382824
Hyphenated Format 68382-824

Supplemental Identifiers

RxCUI
749206
UNII
9YCX42I8IU

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sevelamer carbonate (source: ndc)
Generic Name sevelamer carbonate (source: ndc)
Application Number ANDA207759 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (68382-824-10)
  • 270 TABLET, FILM COATED in 1 BOTTLE (68382-824-27)
  • 10 BLISTER PACK in 1 CARTON (68382-824-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-824-30)
source: ndc

Packages (3)

68382-824-10 1000 TABLET, FILM COATED in 1 BOTTLE (68382-824-10) 68382-824-27 270 TABLET, FILM COATED in 1 BOTTLE (68382-824-27) 68382-824-77 10 BLISTER PACK in 1 CARTON (68382-824-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-824-30)

Ingredients (1)

sevelamer carbonate (800 mg/1)

Linked Drug Pages (1)

Sevelamer carbonate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c36f7488-a329-4113-8027-dfc92bbc6bbc", "openfda": {"unii": ["9YCX42I8IU"], "rxcui": ["749206"], "spl_set_id": ["71f61492-8971-424a-8415-dfd2e15d05d9"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (68382-824-10)", "package_ndc": "68382-824-10", "marketing_start_date": "20200917"}, {"sample": false, "description": "270 TABLET, FILM COATED in 1 BOTTLE (68382-824-27)", "package_ndc": "68382-824-27", "marketing_start_date": "20200917"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-824-77)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-824-30)", "package_ndc": "68382-824-77", "marketing_start_date": "20200917"}], "brand_name": "Sevelamer carbonate", "product_id": "68382-824_c36f7488-a329-4113-8027-dfc92bbc6bbc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "68382-824", "generic_name": "Sevelamer carbonate", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sevelamer carbonate", "active_ingredients": [{"name": "SEVELAMER CARBONATE", "strength": "800 mg/1"}], "application_number": "ANDA207759", "marketing_category": "ANDA", "marketing_start_date": "20200917", "listing_expiration_date": "20261231"}