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 5000 [USP'U]/.5mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-543
Product ID 63323-543_529104c9-6154-4428-953d-5546875f32e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017029
Listing Expiration 2026-12-31
Marketing Start 1972-02-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323543
Hyphenated Format 63323-543

Supplemental Identifiers

RxCUI
1361226 1361574 1361615 1362831 1658634 1658647
UPC
0363323276010 0363323047016 0363323543020
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
  • 5000 [USP'U]/.5mL
source: ndc
Packaging
  • HOW SUPPLIED Heparin Sodium Injection, USP (porcine), preservative free , is available as follows: Product No. NDC No. Strength Fill Volume 27602 63323-276-02 2,000 USP Heparin units per 2 mL (1,000 USP Heparin units per mL) 2 mL fill in a 2 mL single dose, flip-top vial, in packages of 25. 504302 63323-543-02 5,000 USP Heparin units per 0.5 mL 0.5 mL fill in a 2 mL single dose, flip-top vial, in packages of 25. Use only if solution is clear and seal intact. Do not use if solution is discolored or contains a precipitate. Discard unused portion. This container closure is not made from natural rubber latex. Heparin Sodium Injection, USP (porcine) contains benzyl alcohol and is available as follows: Product No. NDC No. Strength Fill Volume 4710 63323-047-10 50,000 USP Heparin units per 10 mL (5,000 USP Heparin units per mL) 10 mL fill in a 10 mL multi-dose, flip-top vial, in packages of 25. 504509 63323-459-09 40,000 USP Heparin units per 4 mL (10,000 USP Heparin units per mL) 4 mL fill in a 5 mL multi-dose, flip-top vial, in packages of 25. Use only if solution is clear and seal intact. Do not use if solution is discolored or contains a precipitate. This container closure is not made from natural rubber latex. Heparin Sodium Injection, USP (porcine) contains parabens and is available in multi-dose, flip-top vials, in packages of 25, as follows: Product No. NDC No. Strength Fill Volume 504001* 63323-540-01 1,000 USP Heparin units per 1 mL 1 mL fill in a 3 mL vial. 504011 63323-540-11 10,000 USP Heparin units per 10 mL (1,000 USP Heparin units per mL) 10 mL fill in a 10 mL vial. 504031 63323-540-31 30,000 USP Heparin units per 30 mL (1,000 USP Heparin units per mL) 30 mL fill in a 30 mL vial. 926201** 63323-262-01 5,000 USP Heparin units per 1 mL 1 mL fill in a 3 mL vial. 504201* 63323-542-01 10,000 USP Heparin units per 1 mL 1 mL fill in a 3 mL vial. 504207 63323-542-07 50,000 USP Heparin units per 5 mL (10,000 USP Heparin units per mL) 5 mL fill in a 6 mL vial. 915501** 63323-915-01 20,000 USP Heparin units per 1 mL 1 mL fill in a 3 mL vial. *Packaged in a plastic or glass vial. **Packaged in a plastic vial. Use only if solution is clear and seal intact. Do not use if solution is discolored or contains a precipitate. This container closure is not made from natural rubber latex.
  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 1 mL Multi-Dose Vial Label Not for Lock Flush Heparin Sodium Injection, USP 1,000 USP units per mL For intravenous or subcutaneous use 1 mL PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 1 mL Multi-Dose Vial Tray Label NDC 63323-540-01 Heparin Sodium Injection, USP 1,000 USP units per mL For intravenous or subcutaneous use 1 mL PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 1 mL Multi-Dose Vial Label Not for Lock Flush Heparin Sodium Injection, USP 5,000 USP units per mL For intravenous or subcutaneous use 1 mL PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 1 mL Multi-Dose Vial Tray Label NDC 63323-262-01 Heparin Sodium Injection, USP 5,000 USP units per mL For intravenous or subcutaneous use 1 mL PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 1 mL Multi-Dose Vial Label Not for Lock Flush Heparin Sodium Injection, USP 10,000 USP units per mL For intravenous or subcutaneous use 1 mL PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 1 mL Multi-Dose Vial Tray Label NDC 63323-542-01 Heparin Sodium Injection, USP 10,000 USP units per mL For intravenous or subcutaneous use 1 mL PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 4 mL Multi-Dose Vial Label Heparin Sodium Injection, USP 40,000 USP units per 4 mL (10,000 USP units per mL) For intravenous or subcutaneous use PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 4 mL Multi-Dose Vial Tray Label NDC 63323-459-09 Heparin Sodium Injection, USP 40,000 USP units per 4 mL (10,000 USP units per mL) For intravenous or subcutaneous use PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 1 mL Multi-Dose Vial Label Not for Lock Flush Heparin Sodium Injection, USP 20,000 USP units per mL For intravenous or subcutaneous use 1 mL PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 1 mL Multi-Dose Vial Tray Label NDC 63323-915-01 Heparin Sodium Injection, USP 20,000 USP units per mL For intravenous or subcutaneous use 1 mL PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 2 mL Single Dose Vial Label Not for Lock Flush NDC 63323-276-01 27602 Heparin Sodium Injection, USP 2,000 USP units per 2 mL (1,000 USP units per mL) For IV or SC use Preservative Free PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 2 mL Single Dose Vial Tray Label NDC 63323-276-02 27602 Heparin Sodium Injection, USP 2,000 USP units per 2 mL (1,000 USP units per mL) For IV or SC use Preservative Free 25 Vials PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 10 mL Multi-Dose Vial Label NDC 63323-047-01 4710 Heparin Sodium Injection, USP 50,000 USP units per 10 mL (5,000 USP units per mL) For intravenous or subcutaneous use PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 10 mL Multi-Dose Tray Label NDC 63323-047-10 4710 Heparin Sodium Injection, USP 50,000 USP units per 10 mL (5,000 USP units per mL) For intravenous or subcutaneous use 25 Vials PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 0.5 mL Single Dose Vial Label Not for Lock Flush Heparin Sodium Injection, USP 5,000 USP units per 0.5 mL For IV or SC use Preservative Free PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 0.5 mL Single Dose Vial Tray Label NDC 63323-543-02 Heparin Sodium Injection, USP 5,000 USP units per 0.5 mL For intravenous or subcutaneous use Preservative Free 504001 504001 926201 926201 504201 504201 504509 504509 915501 915501 27602 27602 4710 4710 504302 504302
source: label

Packages (0)

No package records.

Ingredients (1)

heparin sodium (5000 [USP'U]/.5mL)

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": "529104c9-6154-4428-953d-5546875f32e5", "openfda": {"upc": ["0363323276010", "0363323047016", "0363323543020"], "unii": ["ZZ45AB24CA"], "rxcui": ["1361226", "1361574", "1361615", "1362831", "1658634", "1658647"], "spl_set_id": ["d55b4a63-0c04-4874-b74f-9e9b9e8b008c"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Heparin Sodium", "product_id": "63323-543_529104c9-6154-4428-953d-5546875f32e5", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anti-coagulant [EPC]", "Heparin [CS]", "Unfractionated Heparin [EPC]"], "product_ndc": "63323-543", "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]/.5mL"}], "application_number": "NDA017029", "marketing_category": "NDA", "marketing_start_date": "19720222", "listing_expiration_date": "20261231"}