sevelamer hydrochloride

Generic: sevelamer hydrochloride

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sevelamer hydrochloride
Generic Name sevelamer hydrochloride
Labeler american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sevelamer hydrochloride 800 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-449
Product ID 60687-449_26408f23-0427-1bed-e063-6394a90aa7c8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204724
Listing Expiration 2026-12-31
Marketing Start 2020-01-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687449
Hyphenated Format 60687-449

Supplemental Identifiers

RxCUI
857224
UNII
GLS2PGI8QG

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 hydrochloride (source: ndc)
Generic Name sevelamer hydrochloride (source: ndc)
Application Number ANDA204724 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-449-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-449-11)
source: ndc

Packages (1)

60687-449-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-449-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-449-11)

Ingredients (1)

sevelamer hydrochloride (800 mg/1)

Linked Drug Pages (1)

Sevelamer Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "26408f23-0427-1bed-e063-6394a90aa7c8", "openfda": {"unii": ["GLS2PGI8QG"], "rxcui": ["857224"], "spl_set_id": ["8830526f-d957-423e-84ea-e4d79346948b"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-449-01)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-449-11)", "package_ndc": "60687-449-01", "marketing_start_date": "20200122"}], "brand_name": "Sevelamer Hydrochloride", "product_id": "60687-449_26408f23-0427-1bed-e063-6394a90aa7c8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "60687-449", "generic_name": "Sevelamer Hydrochloride", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sevelamer Hydrochloride", "active_ingredients": [{"name": "SEVELAMER HYDROCHLORIDE", "strength": "800 mg/1"}], "application_number": "ANDA204724", "marketing_category": "ANDA", "marketing_start_date": "20200122", "listing_expiration_date": "20261231"}