sapropterin dihydrochloride

Generic: sapropterin dihydrochloride

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

Drug Facts

Product Profile

Brand Name sapropterin dihydrochloride
Generic Name sapropterin dihydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sapropterin dihydrochloride 100 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0906
Product ID 0054-0906_d61800d3-94cc-46ce-8687-b467c63ac9fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218797
Listing Expiration 2026-12-31
Marketing Start 2025-10-23

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 00540906
Hyphenated Format 0054-0906

Supplemental Identifiers

RxCUI
1486687
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 sapropterin dihydrochloride (source: ndc)
Generic Name sapropterin dihydrochloride (source: ndc)
Application Number ANDA218797 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 120 TABLET in 1 BOTTLE (0054-0906-23)
source: ndc

Packages (1)

0054-0906-23 120 TABLET in 1 BOTTLE (0054-0906-23)

Ingredients (1)

sapropterin dihydrochloride (100 mg/1)

Linked Drug Pages (1)

sapropterin dihydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d61800d3-94cc-46ce-8687-b467c63ac9fa", "openfda": {"unii": ["RG277LF5B3"], "rxcui": ["1486687"], "spl_set_id": ["c4d92cce-e899-4f14-b19c-5e17f9922215"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE (0054-0906-23)", "package_ndc": "0054-0906-23", "marketing_start_date": "20251023"}], "brand_name": "sapropterin dihydrochloride", "product_id": "0054-0906_d61800d3-94cc-46ce-8687-b467c63ac9fa", "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": "0054-0906", "generic_name": "sapropterin dihydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "sapropterin dihydrochloride", "active_ingredients": [{"name": "SAPROPTERIN DIHYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA218797", "marketing_category": "ANDA", "marketing_start_date": "20251023", "listing_expiration_date": "20261231"}