🇺🇸
United States · US · US:25021-840_7617daa7-3c14-4541-8117-690125e356c5
Bludigo
Orange BookUNIISPLATC V04CH02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeV04CH02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1125021840055 AMPULE in 1 CARTON (25021-840-05) / 5 mL in 1 AMPULE
Annotations
UNII (FDA Substance ID)
D3741U8K7L
INDIGOTINDISULFONATE SODIUM
RxCUI 227312
Orange Book
N216264
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "D3741U8K7L",
"rxcui": "227312",
"inchikey": "KHLVKKOJDHCJMG-QDBORUFSSA-L",
"display_name": "INDIGOTINDISULFONATE SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"2b91c39d-5f15-4dcf-9d3d-b378470e6bd7": {
"match": "brand_token",
"title": "BLUDIGO (INDIGOTINDISULFONATE SODIUM) INJECTION [SAGENT PHARMACEUTICALS]",
"spl_version": "1",
"published_date": "2026-04-22"
}
},
"productid": "25021-840_7617daa7-3c14-4541-8117-690125e356c5",
"productndc": "25021-840",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "216264",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "40MG/5ML (8MG/ML)",
"product_no": "001",
"approval_date": "Jul 8, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "INDIGOTINDISULFONATE SODIUM",
"proprietary_name": "Bludigo",
"active_ingred_unit": "mg/mL",
"application_number": "NDA216264",
"marketing_category": "NDA",
"nonproprietary_name": "Indigotindisulfonate Sodium",
"start_marketing_date": "20260415",
"active_numerator_strength": "8"
}Related drugs
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- DKCarmyneSERB S.A.
- NOCarmyneSERB S.A.
- FICarmyneSERB S.A.
- GBIndigo carmine 40mg/10ml solution for injection vialsImported (Italy)
- GBIndigo carmine 40mg/5ml solution for injection ampoulesImported (Australia)
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