kuvan

Generic: sapropterin dihydrochloride

Labeler: biomarin pharmaceutical inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name kuvan
Generic Name sapropterin dihydrochloride
Labeler biomarin pharmaceutical inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sapropterin dihydrochloride 100 mg/1

Manufacturer
BioMarin Pharmaceutical Inc.

Identifiers & Regulatory

Product NDC 68135-300
Product ID 68135-300_c4286a54-6e01-4444-94a0-943411790e1d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022181
Listing Expiration 2026-12-31
Marketing Start 2007-12-14

Pharmacologic Class

Classes
breast cancer resistance protein inhibitors [moa] p-glycoprotein inhibitors [moa] phenylalanine hydroxylase activator [epc] phenylalanine hydroxylase activators [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68135300
Hyphenated Format 68135-300

Supplemental Identifiers

RxCUI
1111018 1111020 1486687 1486691 1653217 1653221
UNII
RG277LF5B3

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 kuvan (source: ndc)
Generic Name sapropterin dihydrochloride (source: ndc)
Application Number NDA022181 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 120 TABLET in 1 BOTTLE (68135-300-02)
source: ndc

Packages (1)

68135-300-02 120 TABLET in 1 BOTTLE (68135-300-02)

Ingredients (1)

sapropterin dihydrochloride (100 mg/1)

Linked Drug Pages (1)

Kuvan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c4286a54-6e01-4444-94a0-943411790e1d", "openfda": {"unii": ["RG277LF5B3"], "rxcui": ["1111018", "1111020", "1486687", "1486691", "1653217", "1653221"], "spl_set_id": ["af38711e-8873-4790-a92d-4d583e23fb89"], "manufacturer_name": ["BioMarin Pharmaceutical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE (68135-300-02)", "package_ndc": "68135-300-02", "marketing_start_date": "20071214"}], "brand_name": "Kuvan", "product_id": "68135-300_c4286a54-6e01-4444-94a0-943411790e1d", "dosage_form": "TABLET", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Phenylalanine Hydroxylase Activator [EPC]", "Phenylalanine Hydroxylase Activators [MoA]"], "product_ndc": "68135-300", "generic_name": "SAPROPTERIN DIHYDROCHLORIDE", "labeler_name": "BioMarin Pharmaceutical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Kuvan", "active_ingredients": [{"name": "SAPROPTERIN DIHYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "NDA022181", "marketing_category": "NDA", "marketing_start_date": "20071214", "listing_expiration_date": "20261231"}