protamine sulfate

Generic: protamine sulfate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name protamine sulfate
Generic Name protamine sulfate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

protamine sulfate 10 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-646
Product ID 65219-646_c76876da-b9a8-45d0-9278-7df3288d3a06
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089454
Listing Expiration 2026-12-31
Marketing Start 2025-03-28

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 65219646
Hyphenated Format 65219-646

Supplemental Identifiers

RxCUI
1796672
UPC
0365219646020
UNII
0DE9724IHC

Packaging Origin

Original Packager
true

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
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (65219-646-05) / 5 mL in 1 VIAL, SINGLE-DOSE (65219-646-02)
source: ndc

Packages (1)

65219-646-05 25 VIAL, SINGLE-DOSE in 1 TRAY (65219-646-05) / 5 mL in 1 VIAL, SINGLE-DOSE (65219-646-02)

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": "c76876da-b9a8-45d0-9278-7df3288d3a06", "openfda": {"upc": ["0365219646020"], "unii": ["0DE9724IHC"], "rxcui": ["1796672"], "spl_set_id": ["c76876da-b9a8-45d0-9278-7df3288d3a06"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (65219-646-05)  / 5 mL in 1 VIAL, SINGLE-DOSE (65219-646-02)", "package_ndc": "65219-646-05", "marketing_start_date": "20250328"}], "brand_name": "Protamine Sulfate", "product_id": "65219-646_c76876da-b9a8-45d0-9278-7df3288d3a06", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Heparin Binding Activity [MoA]", "Heparin Reversal Agent [EPC]", "Reversed Anticoagulation Activity [PE]"], "product_ndc": "65219-646", "generic_name": "PROTAMINE SULFATE", "labeler_name": "Fresenius Kabi USA, LLC", "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": "20250328", "listing_expiration_date": "20261231"}