sapropterin dihydrochloride

Generic: sapropterin dihydrochloride

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sapropterin dihydrochloride
Generic Name sapropterin dihydrochloride
Labeler camber pharmaceuticals, inc.
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

sapropterin dihydrochloride 500 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-048
Product ID 31722-048_4c45ff1f-15f2-2237-e063-6294a90a0aca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215420
Listing Expiration 2027-12-31
Marketing Start 2022-08-18

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 31722048
Hyphenated Format 31722-048

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 ANDA215420 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 PACKET in 1 CARTON (31722-048-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-048-01)
  • 1 PACKET in 1 CARTON (31722-048-31) / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-048-01)
source: ndc

Packages (2)

31722-048-30 30 PACKET in 1 CARTON (31722-048-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-048-01) 31722-048-31 1 PACKET in 1 CARTON (31722-048-31) / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-048-01)

Ingredients (1)

sapropterin dihydrochloride (500 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": "4c45ff1f-15f2-2237-e063-6294a90a0aca", "openfda": {"unii": ["RG277LF5B3"], "rxcui": ["1111018", "1653217"], "spl_set_id": ["3f0d6820-ff59-40c0-882f-aeea2dd1d1ad"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 PACKET in 1 CARTON (31722-048-30)  / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-048-01)", "package_ndc": "31722-048-30", "marketing_start_date": "20220818"}, {"sample": false, "description": "1 PACKET in 1 CARTON (31722-048-31)  / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-048-01)", "package_ndc": "31722-048-31", "marketing_start_date": "20220818"}], "brand_name": "Sapropterin dihydrochloride", "product_id": "31722-048_4c45ff1f-15f2-2237-e063-6294a90a0aca", "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": "31722-048", "generic_name": "Sapropterin dihydrochloride", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sapropterin dihydrochloride", "active_ingredients": [{"name": "SAPROPTERIN DIHYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA215420", "marketing_category": "ANDA", "marketing_start_date": "20220818", "listing_expiration_date": "20271231"}