sevelamer carbonate

Generic: sevelamer carbonate

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

sevelamer carbonate 800 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-814
Product ID 16714-814_a2199a9d-47ad-4994-ba6f-af6e4d1ad7da
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207179
Listing Expiration 2026-12-31
Marketing Start 2018-06-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714814
Hyphenated Format 16714-814

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 ANDA207179 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 270 TABLET, FILM COATED in 1 BOTTLE (16714-814-01)
source: ndc

Packages (1)

16714-814-01 270 TABLET, FILM COATED in 1 BOTTLE (16714-814-01)

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": "a2199a9d-47ad-4994-ba6f-af6e4d1ad7da", "openfda": {"unii": ["9YCX42I8IU"], "rxcui": ["749206"], "spl_set_id": ["9b4d0720-f4e7-4b4f-affc-57ce8bb0b722"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "270 TABLET, FILM COATED in 1 BOTTLE (16714-814-01)", "package_ndc": "16714-814-01", "marketing_start_date": "20180606"}], "brand_name": "Sevelamer Carbonate", "product_id": "16714-814_a2199a9d-47ad-4994-ba6f-af6e4d1ad7da", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "16714-814", "generic_name": "Sevelamer Carbonate", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sevelamer Carbonate", "active_ingredients": [{"name": "SEVELAMER CARBONATE", "strength": "800 mg/1"}], "application_number": "ANDA207179", "marketing_category": "ANDA", "marketing_start_date": "20180606", "listing_expiration_date": "20261231"}