🇺🇸
United States · US · US:65219-646_c76876da-b9a8-45d0-9278-7df3288d3a06
Protamine Sulfate
Orange BookUNIISPLATC V03AB14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeV03AB14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11652196460525 VIAL, SINGLE-DOSE in 1 TRAY (65219-646-05) / 5 mL in 1 VIAL, SINGLE-DOSE (65219-646-02)
Annotations
UNII (FDA Substance ID)
0DE9724IHC
PROTAMINE SULFATE
RxCUI 8825
Orange Book
A089454
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0DE9724IHC",
"rxcui": "8825",
"inchikey": null,
"display_name": "PROTAMINE SULFATE",
"substance_type": "structurallyDiverse",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"c76876da-b9a8-45d0-9278-7df3288d3a06": {
"match": "brand_token",
"title": "PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]",
"spl_version": "1",
"published_date": "2025-05-15"
}
},
"productid": "65219-646_c76876da-b9a8-45d0-9278-7df3288d3a06",
"productndc": "65219-646",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "089454",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "50MG/5ML (10MG/ML)",
"product_no": "001",
"approval_date": "Apr 7, 1987"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "250MG/25ML (10MG/ML)",
"product_no": "002",
"approval_date": "Apr 7, 1987"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PROTAMINE SULFATE",
"proprietary_name": "Protamine Sulfate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA089454",
"marketing_category": "ANDA",
"nonproprietary_name": "PROTAMINE SULFATE",
"start_marketing_date": "20250328",
"active_numerator_strength": "10"
}Related drugs
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- BEProtamine Sulfaat Leo Pharma 1400 IU/mlLeo Pharma
- 🇺🇸Protamine SulfateFresenius Kabi USA, LLC
- 🇺🇸Protamine SulfateFresenius Kabi USA, LLC
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