heparin sodium

Generic: heparin sodium

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

Drug Facts

Product Profile

Brand Name heparin sodium
Generic Name heparin sodium
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

heparin sodium 20000 [USP'U]/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-915
Product ID 63323-915_93ca100a-e82b-41de-bdd5-355097f4d567
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017029
Listing Expiration 2026-12-31
Marketing Start 2019-11-04

Pharmacologic Class

Classes
anti-coagulant [epc] heparin [cs] unfractionated heparin [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323915
Hyphenated Format 63323-915

Supplemental Identifiers

RxCUI
1361226 1361574 1361615 1362831 1658634
UPC
0363323915032 0363323540036 0363323540050 0363323540333 0363323542092 0363323543037 0363323542047
UNII
ZZ45AB24CA

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 heparin sodium (source: ndc)
Generic Name heparin sodium (source: ndc)
Application Number NDA017029 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 20000 [USP'U]/mL
source: ndc
Packaging
  • 25 VIAL in 1 TRAY (63323-915-13) / 1 mL in 1 VIAL (63323-915-03)
source: ndc

Packages (1)

63323-915-13 25 VIAL in 1 TRAY (63323-915-13) / 1 mL in 1 VIAL (63323-915-03)

Ingredients (1)

heparin sodium (20000 [USP'U]/mL)

Linked Drug Pages (2)

Heparin Sodium ndc-match (0.9) Heparin Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "93ca100a-e82b-41de-bdd5-355097f4d567", "openfda": {"upc": ["0363323915032", "0363323540036", "0363323540050", "0363323540333", "0363323542092", "0363323543037", "0363323542047"], "unii": ["ZZ45AB24CA"], "rxcui": ["1361226", "1361574", "1361615", "1362831", "1658634"], "spl_set_id": ["2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 TRAY (63323-915-13)  / 1 mL in 1 VIAL (63323-915-03)", "package_ndc": "63323-915-13", "marketing_start_date": "20191104"}], "brand_name": "Heparin Sodium", "product_id": "63323-915_93ca100a-e82b-41de-bdd5-355097f4d567", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anti-coagulant [EPC]", "Heparin [CS]", "Unfractionated Heparin [EPC]"], "product_ndc": "63323-915", "generic_name": "HEPARIN SODIUM", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Heparin Sodium", "active_ingredients": [{"name": "HEPARIN SODIUM", "strength": "20000 [USP'U]/mL"}], "application_number": "NDA017029", "marketing_category": "NDA", "marketing_start_date": "20191104", "listing_expiration_date": "20261231"}