NDC 51662-1414

PROTAMINE SULFATE

Protamine Sulfate

PROTAMINE SULFATE is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hf Acquisition Co Llc, Dba Healthfirst. The primary component is Protamine Sulfate.

• Product ID: 51662-1414_94d4f57f-940f-c0a8-e053-2a95a90ae3af
• NDC: 51662-1414
• Product Type: Human Prescription Drug
• Proprietary Name: PROTAMINE SULFATE
• Generic Name: Protamine Sulfate
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-10-13
• Marketing Category: ANDA / ANDA
• Application Number: ANDA089454
• Labeler Name: HF Acquisition Co LLC, DBA HealthFirst
• Substance Name: PROTAMINE SULFATE
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: Heparin Binding Activity [MoA],Heparin Reversal Agent [EPC],Reversed Anticoagulation Activity [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 51662-1414-1

5 mL in 1 VIAL, SINGLE-DOSE (51662-1414-1)

• Marketing Start Date: 2019-10-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51662-1414-1 [51662141401]

PROTAMINE SULFATE INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA089454
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-10-13

Drug Details

Active Ingredients

Ingredient	Strength
PROTAMINE SULFATE	10 mg/mL

OpenFDA Data

• SPL SET ID: 94d4f57f-940e-c0a8-e053-2a95a90ae3af
• Manufacturer:
  • HF Acquisition Co LLC, DBA HealthFirst
• UNII:
  • 0DE9724IHC
• RxNorm Concept Unique ID - RxCUI:
  • 1796672
• UPC Code:
  • 0363323229054

Pharmacological Class

• Heparin Binding Activity [MoA]
• Heparin Reversal Agent [EPC]
• Reversed Anticoagulation Activity [PE]

NDC Crossover Matching brand name "PROTAMINE SULFATE" or generic name "Protamine Sulfate"

NDC	Brand Name	Generic Name
51662-1414	PROTAMINE SULFATE	PROTAMINE SULFATE
63323-229	Protamine Sulfate	PROTAMINE SULFATE