🇺🇸
United States · US · US:43598-097_f6a11439-21eb-fc03-1869-6960d7cf8791
JAVYGTOR
Orange BookUNIISPLATC A16AX07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddys Laboratories Inc
CountryUS (United States)
ATC codeA16AX07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11435980973030 PACKET in 1 CARTON (43598-097-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (43598-097-11)
Annotations
UNII (FDA Substance ID)
RG277LF5B3
SAPROPTERIN DIHYDROCHLORIDE
RxCUI 753341
Orange Book
A209452
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "RG277LF5B3",
"rxcui": "753341",
"inchikey": "RKSUYBCOVNCALL-NTVURLEBSA-N",
"display_name": "SAPROPTERIN DIHYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"eecdd8c7-5f8a-0af1-793a-db2e2ba0f491": {
"match": "brand_token",
"title": "JAVYGTOR (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [DR. REDDYS LABORATORIES INC]",
"spl_version": "4",
"published_date": "2025-01-23"
}
},
"productid": "43598-097_f6a11439-21eb-fc03-1869-6960d7cf8791",
"productndc": "43598-097",
"dosage_form": "POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "209452",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG/PACKET",
"product_no": "001",
"approval_date": "Mar 30, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SAPROPTERIN DIHYDROCHLORIDE",
"proprietary_name": "JAVYGTOR",
"active_ingred_unit": "mg/1",
"application_number": "ANDA209452",
"marketing_category": "ANDA",
"nonproprietary_name": "Sapropterin Dihydrochloride",
"start_marketing_date": "20220916",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code A16AX07.
- DKArpetranPIAM Farmaceutici S.P.A.
- NLArpetran 100 mg oplosbare tablettenPIAM Farmaceutici S.p.A.
- 🇮🇹ARPETRAN*120 cpr solub 100 mgPIAM FARMACEUTICI SpA
- 🇺🇸JAVYGTORDr. Reddys Laboratories Inc
- 🇺🇸JAVYGTORDr. Reddys Laboratories Inc
- ISKuvanBioMarin International Limited
- PLKuvanBioMarin International Ltd.
- ISKuvanBioMarin International Limited
Access this data programmatically
Query JAVYGTOR and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.