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United States · US · US:71288-805_1c9d3281-9ee0-4e8c-9d36-7736ada64138
Isosulfan Blue
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMeitheal Pharmaceuticals Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171288805066 VIAL, SINGLE-DOSE in 1 CARTON (71288-805-06) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-805-05)
Annotations
UNII (FDA Substance ID)
39N9K8S2A4
ISOSULFAN BLUE
RxCUI 27863
Orange Book
A213130
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "39N9K8S2A4",
"rxcui": "27863",
"inchikey": "NLUFDZBOHMOBOE-UHFFFAOYSA-M",
"display_name": "ISOSULFAN BLUE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"0391e544-3633-48df-9f3a-ed16183125b1": {
"match": "brand_token",
"title": "ISOSULFAN BLUE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]",
"spl_version": "2",
"published_date": "2026-05-25"
}
},
"productid": "71288-805_1c9d3281-9ee0-4e8c-9d36-7736ada64138",
"productndc": "71288-805",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "213130",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "50MG/5ML (10MG/ML)",
"product_no": "001",
"approval_date": "Nov 3, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ISOSULFAN BLUE",
"proprietary_name": "Isosulfan Blue",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA213130",
"marketing_category": "ANDA",
"nonproprietary_name": "Isosulfan Blue",
"start_marketing_date": "20211103",
"active_numerator_strength": "10"
}Access this data programmatically
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