sapropterin dihydrochloride

Generic: sapropterin dihydrochloride

Labeler: trupharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sapropterin dihydrochloride
Generic Name sapropterin dihydrochloride
Labeler trupharma, llc
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

sapropterin dihydrochloride 100 mg/1

Manufacturer
TRUPHARMA, LLC

Identifiers & Regulatory

Product NDC 52817-850
Product ID 52817-850_4b1fe6f7-f641-ec9a-e063-6394a90a4e04
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216432
Listing Expiration 2027-12-31
Marketing Start 2026-01-30

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 52817850
Hyphenated Format 52817-850

Supplemental Identifiers

RxCUI
1111018 1653217
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 ANDA216432 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1 POWDER, FOR SOLUTION in 1 POUCH (52817-850-01)
  • 30 POWDER, FOR SOLUTION in 1 CARTON (52817-850-30)
source: ndc

Packages (2)

52817-850-01 1 POWDER, FOR SOLUTION in 1 POUCH (52817-850-01) 52817-850-30 30 POWDER, FOR SOLUTION in 1 CARTON (52817-850-30)

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": "4b1fe6f7-f641-ec9a-e063-6394a90a4e04", "openfda": {"unii": ["RG277LF5B3"], "rxcui": ["1111018", "1653217"], "spl_set_id": ["39f1d020-4359-401b-88a8-ed25eaa40b45"], "manufacturer_name": ["TRUPHARMA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POWDER, FOR SOLUTION in 1 POUCH (52817-850-01)", "package_ndc": "52817-850-01", "marketing_start_date": "20260130"}, {"sample": false, "description": "30 POWDER, FOR SOLUTION in 1 CARTON (52817-850-30)", "package_ndc": "52817-850-30", "marketing_start_date": "20260130"}], "brand_name": "Sapropterin Dihydrochloride", "product_id": "52817-850_4b1fe6f7-f641-ec9a-e063-6394a90a4e04", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Phenylalanine Hydroxylase Activator [EPC]", "Phenylalanine Hydroxylase Activators [MoA]"], "product_ndc": "52817-850", "generic_name": "Sapropterin Dihydrochloride", "labeler_name": "TRUPHARMA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sapropterin Dihydrochloride", "active_ingredients": [{"name": "SAPROPTERIN DIHYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA216432", "marketing_category": "ANDA", "marketing_start_date": "20260130", "listing_expiration_date": "20271231"}