heparin sodium

Generic: heparin sodium

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA 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 5000 [USP'U]/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 76045-108
Product ID 76045-108_fb5b2c56-f5ea-42c9-a6d8-37a03770290b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206552
Listing Expiration 2026-12-31
Marketing Start 2016-06-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76045108
Hyphenated Format 76045-108

Supplemental Identifiers

RxCUI
1798389
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 ANDA206552 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 5000 [USP'U]/mL
source: ndc
Packaging
  • 24 BLISTER PACK in 1 CARTON (76045-108-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-108-00) / 1 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

76045-108-10 24 BLISTER PACK in 1 CARTON (76045-108-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-108-00) / 1 mL in 1 SYRINGE, GLASS

Ingredients (1)

heparin sodium (5000 [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": "fb5b2c56-f5ea-42c9-a6d8-37a03770290b", "openfda": {"unii": ["ZZ45AB24CA"], "rxcui": ["1798389"], "spl_set_id": ["07438e10-1589-4683-9f26-e5494d076cf0"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BLISTER PACK in 1 CARTON (76045-108-10)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-108-00)  / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "76045-108-10", "marketing_start_date": "20160610"}], "brand_name": "Heparin Sodium", "product_id": "76045-108_fb5b2c56-f5ea-42c9-a6d8-37a03770290b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anti-coagulant [EPC]", "Heparin [CS]", "Unfractionated Heparin [EPC]"], "product_ndc": "76045-108", "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": "5000 [USP'U]/mL"}], "application_number": "ANDA206552", "marketing_category": "ANDA", "marketing_start_date": "20160610", "listing_expiration_date": "20261231"}