protamine sulfate

Generic: protamine sulfate

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name protamine sulfate
Generic Name protamine sulfate
Labeler hf acquisition co llc, dba healthfirst
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

protamine sulfate 10 mg/mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1414
Product ID 51662-1414_0f90d77c-0de8-d2a3-e063-6394a90a067d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089454
Listing Expiration 2026-12-31
Marketing Start 2019-10-13

Pharmacologic Class

Classes
heparin binding activity [moa] heparin reversal agent [epc] reversed anticoagulation activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516621414
Hyphenated Format 51662-1414

Supplemental Identifiers

RxCUI
1796672
UPC
0363323229054
UNII
0DE9724IHC

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name protamine sulfate (source: ndc)
Generic Name protamine sulfate (source: ndc)
Application Number ANDA089454 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 5 mL in 1 VIAL, SINGLE-DOSE (51662-1414-1)
  • 25 POUCH in 1 CASE (51662-1414-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1414-2) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

51662-1414-1 5 mL in 1 VIAL, SINGLE-DOSE (51662-1414-1) 51662-1414-3 25 POUCH in 1 CASE (51662-1414-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1414-2) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

protamine sulfate (10 mg/mL)

Linked Drug Pages (1)

PROTAMINE SULFATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "0f90d77c-0de8-d2a3-e063-6394a90a067d", "openfda": {"upc": ["0363323229054"], "unii": ["0DE9724IHC"], "rxcui": ["1796672"], "spl_set_id": ["94d4f57f-940e-c0a8-e053-2a95a90ae3af"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 VIAL, SINGLE-DOSE (51662-1414-1)", "package_ndc": "51662-1414-1", "marketing_start_date": "20191013"}, {"sample": false, "description": "25 POUCH in 1 CASE (51662-1414-3)  / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1414-2)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "51662-1414-3", "marketing_start_date": "20230616"}], "brand_name": "PROTAMINE SULFATE", "product_id": "51662-1414_0f90d77c-0de8-d2a3-e063-6394a90a067d", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Heparin Binding Activity [MoA]", "Heparin Reversal Agent [EPC]", "Reversed Anticoagulation Activity [PE]"], "product_ndc": "51662-1414", "generic_name": "PROTAMINE SULFATE", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROTAMINE SULFATE", "active_ingredients": [{"name": "PROTAMINE SULFATE", "strength": "10 mg/mL"}], "application_number": "ANDA089454", "marketing_category": "ANDA", "marketing_start_date": "20191013", "listing_expiration_date": "20261231"}