javygtor

Generic: sapropterin dihydrochloride

Labeler: dr. reddys laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name javygtor
Generic Name sapropterin dihydrochloride
Labeler dr. reddys laboratories inc
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

sapropterin dihydrochloride 100 mg/1

Manufacturer
Dr. Reddys Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-097
Product ID 43598-097_f6a11439-21eb-fc03-1869-6960d7cf8791
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209452
Listing Expiration 2026-12-31
Marketing Start 2022-09-16

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 43598097
Hyphenated Format 43598-097

Supplemental Identifiers

RxCUI
1111018 2611951
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 javygtor (source: ndc)
Generic Name sapropterin dihydrochloride (source: ndc)
Application Number ANDA209452 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 PACKET in 1 CARTON (43598-097-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (43598-097-11)
source: ndc

Packages (1)

43598-097-30 30 PACKET in 1 CARTON (43598-097-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (43598-097-11)

Ingredients (1)

sapropterin dihydrochloride (100 mg/1)

Linked Drug Pages (1)

JAVYGTOR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f6a11439-21eb-fc03-1869-6960d7cf8791", "openfda": {"unii": ["RG277LF5B3"], "rxcui": ["1111018", "2611951"], "spl_set_id": ["1590afa1-baa4-70e5-5a3b-468401c71044"], "manufacturer_name": ["Dr. Reddys Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 PACKET in 1 CARTON (43598-097-30)  / 1 POWDER, FOR SOLUTION in 1 PACKET (43598-097-11)", "package_ndc": "43598-097-30", "marketing_start_date": "20220916"}], "brand_name": "JAVYGTOR", "product_id": "43598-097_f6a11439-21eb-fc03-1869-6960d7cf8791", "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": "43598-097", "generic_name": "Sapropterin Dihydrochloride", "labeler_name": "Dr. Reddys Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "JAVYGTOR", "active_ingredients": [{"name": "SAPROPTERIN DIHYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA209452", "marketing_category": "ANDA", "marketing_start_date": "20220916", "listing_expiration_date": "20261231"}