sevelamer carbonate

Generic: sevelamer carbonate

Labeler: precision dose, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sevelamer carbonate
Generic Name sevelamer carbonate
Labeler precision dose, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sevelamer carbonate 800 mg/1

Manufacturer
Precision Dose, Inc.

Identifiers & Regulatory

Product NDC 68094-034
Product ID 68094-034_85aed37f-f40b-4b15-92e5-037629c95e65
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207288
Listing Expiration 2026-12-31
Marketing Start 2021-06-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68094034
Hyphenated Format 68094-034

Supplemental Identifiers

RxCUI
749206
UPC
0368094034647
UNII
9YCX42I8IU

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 ANDA207288 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 9 BLISTER PACK in 1 CARTON (68094-034-64) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68094-034-59)
source: ndc

Packages (1)

68094-034-64 9 BLISTER PACK in 1 CARTON (68094-034-64) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68094-034-59)

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": "85aed37f-f40b-4b15-92e5-037629c95e65", "openfda": {"upc": ["0368094034647"], "unii": ["9YCX42I8IU"], "rxcui": ["749206"], "spl_set_id": ["09b5e422-18c9-49dc-be3d-5d24648184af"], "manufacturer_name": ["Precision Dose, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "9 BLISTER PACK in 1 CARTON (68094-034-64)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (68094-034-59)", "package_ndc": "68094-034-64", "marketing_start_date": "20210623"}], "brand_name": "Sevelamer Carbonate", "product_id": "68094-034_85aed37f-f40b-4b15-92e5-037629c95e65", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "68094-034", "generic_name": "Sevelamer Carbonate", "labeler_name": "Precision Dose, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sevelamer Carbonate", "active_ingredients": [{"name": "SEVELAMER CARBONATE", "strength": "800 mg/1"}], "application_number": "ANDA207288", "marketing_category": "ANDA", "marketing_start_date": "20210623", "listing_expiration_date": "20261231"}