sevelamer carbonate

Generic: sevelamer carbonate

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

Drug Facts

Product Profile

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

sevelamer carbonate 800 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-967
Product ID 69097-967_444a974f-7f31-4b53-93c9-f5b9a251f711
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203860
Listing Expiration 2026-12-31
Marketing Start 2017-10-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097967
Hyphenated Format 69097-967

Supplemental Identifiers

RxCUI
749206
UPC
0369097967932
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 ANDA203860 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 270 TABLET, FILM COATED in 1 BOTTLE (69097-967-93)
source: ndc

Packages (1)

69097-967-93 270 TABLET, FILM COATED in 1 BOTTLE (69097-967-93)

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": "444a974f-7f31-4b53-93c9-f5b9a251f711", "openfda": {"upc": ["0369097967932"], "unii": ["9YCX42I8IU"], "rxcui": ["749206"], "spl_set_id": ["134f32c1-b5d5-44d0-9da5-85033e99320a"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "270 TABLET, FILM COATED in 1 BOTTLE (69097-967-93)", "package_ndc": "69097-967-93", "marketing_start_date": "20190808"}], "brand_name": "Sevelamer carbonate", "product_id": "69097-967_444a974f-7f31-4b53-93c9-f5b9a251f711", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "69097-967", "generic_name": "SEVELAMER CARBONATE", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sevelamer carbonate", "active_ingredients": [{"name": "SEVELAMER CARBONATE", "strength": "800 mg/1"}], "application_number": "ANDA203860", "marketing_category": "ANDA", "marketing_start_date": "20171026", "listing_expiration_date": "20261231"}