heparin sodium

Generic: heparin sodium

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name heparin sodium
Generic Name heparin sodium
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

heparin sodium 1000 [USP'U]/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-0391
Product ID 0641-0391_c2b599e9-2767-46cc-bc7a-1d8a63f91721
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017037
Listing Expiration 2026-12-31
Marketing Start 1972-03-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06410391
Hyphenated Format 0641-0391

Supplemental Identifiers

RxCUI
1361226 1361615 1362831 1659263 1798389 2121591
UPC
0306412450557 0306412460556
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 NDA017037 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1000 [USP'U]/mL
source: ndc
Packaging
  • 25 VIAL in 1 PACKAGE (0641-0391-12) / 1 mL in 1 VIAL (0641-0391-37)
source: ndc

Packages (1)

0641-0391-12 25 VIAL in 1 PACKAGE (0641-0391-12) / 1 mL in 1 VIAL (0641-0391-37)

Ingredients (1)

heparin sodium (1000 [USP'U]/mL)

Linked Drug Pages (1)

Heparin Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "c2b599e9-2767-46cc-bc7a-1d8a63f91721", "openfda": {"upc": ["0306412450557", "0306412460556"], "unii": ["ZZ45AB24CA"], "rxcui": ["1361226", "1361615", "1362831", "1659263", "1798389", "2121591"], "spl_set_id": ["7014808d-cec9-4b2c-8eb5-940493e356ab"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 PACKAGE (0641-0391-12)  / 1 mL in 1 VIAL (0641-0391-37)", "package_ndc": "0641-0391-12", "marketing_start_date": "19720322"}], "brand_name": "Heparin Sodium", "product_id": "0641-0391_c2b599e9-2767-46cc-bc7a-1d8a63f91721", "dosage_form": "INJECTION", "pharm_class": ["Anti-coagulant [EPC]", "Heparin [CS]", "Unfractionated Heparin [EPC]"], "product_ndc": "0641-0391", "generic_name": "Heparin Sodium", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Heparin Sodium", "active_ingredients": [{"name": "HEPARIN SODIUM", "strength": "1000 [USP'U]/mL"}], "application_number": "NDA017037", "marketing_category": "NDA", "marketing_start_date": "19720322", "listing_expiration_date": "20261231"}