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
Active Ingredients

heparin sodium 200 [USP'U]/100mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-519
Product ID 63323-519_3bbbe74a-1246-41a6-9fc3-ca0230529b40
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212441
Listing Expiration 2026-12-31
Marketing Start 2020-07-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323519
Hyphenated Format 63323-519

Supplemental Identifiers

RxCUI
1658690 1658692
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 ANDA212441 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 [USP'U]/100mL
source: ndc
Packaging
  • 12 BAG in 1 CASE (63323-519-10) / 1000 mL in 1 BAG (63323-519-01)
  • 24 BAG in 1 CASE (63323-519-77) / 500 mL in 1 BAG (63323-519-02)
source: ndc

Packages (2)

63323-519-10 12 BAG in 1 CASE (63323-519-10) / 1000 mL in 1 BAG (63323-519-01) 63323-519-77 24 BAG in 1 CASE (63323-519-77) / 500 mL in 1 BAG (63323-519-02)

Ingredients (1)

heparin sodium (200 [USP'U]/100mL)

Linked Drug Pages (1)

Heparin Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3bbbe74a-1246-41a6-9fc3-ca0230529b40", "openfda": {"unii": ["ZZ45AB24CA"], "rxcui": ["1658690", "1658692"], "spl_set_id": ["25b0ba06-3274-4a3f-8c39-42d13764ecdf"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BAG in 1 CASE (63323-519-10)  / 1000 mL in 1 BAG (63323-519-01)", "package_ndc": "63323-519-10", "marketing_start_date": "20200724"}, {"sample": false, "description": "24 BAG in 1 CASE (63323-519-77)  / 500 mL in 1 BAG (63323-519-02)", "package_ndc": "63323-519-77", "marketing_start_date": "20200724"}], "brand_name": "Heparin Sodium", "product_id": "63323-519_3bbbe74a-1246-41a6-9fc3-ca0230529b40", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anti-coagulant [EPC]", "Heparin [CS]", "Unfractionated Heparin [EPC]"], "product_ndc": "63323-519", "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": "200 [USP'U]/100mL"}], "application_number": "ANDA212441", "marketing_category": "ANDA", "marketing_start_date": "20200724", "listing_expiration_date": "20261231"}