🇺🇸
United States · US · US:0517-0374_420bd985-ac55-44b9-b8a0-a5098220575b
PROVAYBLUE
Orange BookUNIISPLATC V03AB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmerican Regent, Inc.
CountryUS (United States)
ATC codeV03AB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1105170374055 AMPULE in 1 CARTON (0517-0374-05) / 10 mL in 1 AMPULE (0517-0374-01)
Annotations
UNII (FDA Substance ID)
T42P99266K
METHYLENE BLUE
RxCUI 6878
Orange Book
N204630
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "T42P99266K",
"rxcui": "6878",
"inchikey": "XQAXGZLFSSPBMK-UHFFFAOYSA-M",
"display_name": "METHYLENE BLUE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"4f6848e5-35ed-4046-b13c-3032b5ba3232": {
"match": "brand_token",
"title": "PROVAYBLUE (METHYLENE BLUE) INJECTION [AMERICAN REGENT, INC.]",
"spl_version": "28",
"published_date": "2025-06-12"
}
},
"productid": "0517-0374_420bd985-ac55-44b9-b8a0-a5098220575b",
"productndc": "0517-0374",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "204630",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "50MG/10ML (5MG/ML)",
"product_no": "001",
"approval_date": "Apr 8, 2016"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "10MG/2ML (5MG/ML)",
"product_no": "002",
"approval_date": "Jul 18, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METHYLENE BLUE",
"proprietary_name": "PROVAYBLUE",
"active_ingred_unit": "mg/mL",
"application_number": "NDA204630",
"marketing_category": "NDA",
"nonproprietary_name": "methylene blue",
"start_marketing_date": "20160408",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code V03AB.
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- 🇪🇸BRIDION 100 MG/ML SOLUCION INYECTABLEMerck Sharp & Dohme B.V.
- 🇪🇸BRIDION 100 MG/ML SOLUCION INYECTABLEMerck Sharp & Dohme B.V.
- 🇫🇷BRIDION 100 mg/mL, solution injectableMERCK SHARP & DOHME (PAYS-BAS)
- NOCalgonateCalgonate Corp
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