🇺🇸
United States · US · US:43598-096_ce2e0e3a-40e4-33ed-3cad-e166dd2245a1
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 · 3
- ndc114359809604120 TABLET in 1 BOTTLE (43598-096-04)
- ndc114359809605500 TABLET in 1 BOTTLE (43598-096-05)
- ndc11435980963030 TABLET in 1 BOTTLE (43598-096-30)
Annotations
UNII (FDA Substance ID)
RG277LF5B3
SAPROPTERIN DIHYDROCHLORIDE
RxCUI 753341
Orange Book
A207685
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": "43598-096_ce2e0e3a-40e4-33ed-3cad-e166dd2245a1",
"productndc": "43598-096",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "207685",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Jun 15, 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": "ANDA207685",
"marketing_category": "ANDA",
"nonproprietary_name": "Sapropterin Dihydrochloride",
"start_marketing_date": "20221003",
"active_numerator_strength": "100"
}Related drugs
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- 🇺🇸JAVYGTORDr. Reddys Laboratories Inc
- PLKuvanBioMarin International Ltd.
- ISKuvanBioMarin International Limited
- PLKuvanBioMarin International Ltd.
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