sevelamer carbonate

Generic: sevelamer carbonate

Labeler: navinta llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sevelamer carbonate
Generic Name sevelamer carbonate
Labeler navinta llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sevelamer carbonate 800 mg/1

Manufacturer
Navinta LLC

Identifiers & Regulatory

Product NDC 68475-010
Product ID 68475-010_d3c74ca1-7175-40a4-b96f-f864b7f47846
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219931
Listing Expiration 2027-12-31
Marketing Start 2025-11-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68475010
Hyphenated Format 68475-010

Supplemental Identifiers

RxCUI
749206
UPC
0368475010017 0368475010024 0368475010031
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 ANDA219931 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (68475-010-01)
  • 270 TABLET, FILM COATED in 1 BOTTLE (68475-010-02)
  • 180 TABLET, FILM COATED in 1 BOTTLE (68475-010-03)
source: ndc

Packages (3)

68475-010-01 30 TABLET, FILM COATED in 1 BOTTLE (68475-010-01) 68475-010-02 270 TABLET, FILM COATED in 1 BOTTLE (68475-010-02) 68475-010-03 180 TABLET, FILM COATED in 1 BOTTLE (68475-010-03)

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": "d3c74ca1-7175-40a4-b96f-f864b7f47846", "openfda": {"upc": ["0368475010017", "0368475010024", "0368475010031"], "unii": ["9YCX42I8IU"], "rxcui": ["749206"], "spl_set_id": ["d2f0c283-3e9d-41db-bd4d-83bd21f2a019"], "manufacturer_name": ["Navinta LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68475-010-01)", "package_ndc": "68475-010-01", "marketing_start_date": "20251101"}, {"sample": false, "description": "270 TABLET, FILM COATED in 1 BOTTLE (68475-010-02)", "package_ndc": "68475-010-02", "marketing_start_date": "20251101"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (68475-010-03)", "package_ndc": "68475-010-03", "marketing_start_date": "20260102"}], "brand_name": "Sevelamer carbonate", "product_id": "68475-010_d3c74ca1-7175-40a4-b96f-f864b7f47846", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "68475-010", "generic_name": "Sevelamer carbonate", "labeler_name": "Navinta LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sevelamer carbonate", "active_ingredients": [{"name": "SEVELAMER CARBONATE", "strength": "800 mg/1"}], "application_number": "ANDA219931", "marketing_category": "ANDA", "marketing_start_date": "20251101", "listing_expiration_date": "20271231"}