🇺🇸
United States · US · US:51662-1414_0f90d77c-0de8-d2a3-e063-6394a90a067d
PROTAMINE SULFATE
Orange BookUNIISPLATC V03AB14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHF Acquisition Co LLC, DBA HealthFirst
CountryUS (United States)
ATC codeV03AB14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1151662141415 mL in 1 VIAL, SINGLE-DOSE (51662-1414-1)
- ndc11516621414325 POUCH in 1 CASE (51662-1414-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1414-2) / 5 mL in 1 VIAL, SINGLE-DOSE
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": "51662-1414_0f90d77c-0de8-d2a3-e063-6394a90a067d",
"productndc": "51662-1414",
"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": "20191013",
"active_numerator_strength": "10"
}Related drugs
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- 🇫🇷PROTAMINE CHOAY 1000 U.A.H./ml, solution injectableCHEPLAPHARM ARZNEIMITTEL (ALLEMAGNE)
- NLProtamine sulfaat LEO Pharma 1400 anti-heparine IE/ml oplossing voor injectie en infusieLeo Pharma A/S
- BEProtamine Sulfaat Leo Pharma 1400 IU/mlLeo Pharma
- 🇺🇸Protamine SulfateFresenius Kabi USA, LLC
- 🇺🇸Protamine SulfateFresenius Kabi USA, LLC
Access this data programmatically
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