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
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Heparin Sodium Injection, USP (porcine), preservative free , is available as follows: Product Code Unit of Sale Strength Each 27602 NDC 63323-276-02 Unit of 25 2,000 USP units per 2 mL (1,000 USP units per mL) NDC 63323-276-01 2 mL single-dose, flip-top vial 504313 NDC 63323-543-13 Unit of 25 5,000 USP units per 0.5 mL NDC 63323-543-03 0.5 mL fill in a 2 mL single-dose, flip-top 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 with natural rubber latex. Discard unused portion. Heparin Sodium Injection, USP (porcine) contains benzyl alcohol and is available as follows: Product Code Unit of Sale Strength Each 4710 NDC 63323-047-10 Unit of 25 50,000 USP units per 10 mL (5,000 USP units per mL) NDC 63323-047-01 10 mL multiple-dose, flip-top vial 504514 NDC 63323-459-14 Unit of 25 40,000 USP units per 4 mL (10,000 USP units per mL) NDC 63323-459-04 4 mL fill in a 5 mL multiple-dose, flip-top 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 with natural rubber latex. Heparin Sodium Injection, USP (porcine) contains parabens and is available as follows: Product Code Unit of Sale Strength Each 504013 NDC 63323-540-13 Unit of 25 1,000 USP units per mL NDC 63323-540-03 1 mL fill in a 2 mL multiple-dose, flip-top vial 504015 NDC 63323-540-15 Unit of 25 10,000 USP units per 10 mL (1,000 USP units per mL) NDC 63323-540-05 10 mL multiple-dose, flip-top vial RF504015 NDC 65219-066-10 Unit of 25 10,000 USP units per 10 mL (1,000 USP units per mL) NDC 65219-066-01 10 mL multiple-dose, flip-top vial This product contains an RFID 504036 NDC 63323-540-36 Unit of 25 30,000 USP units per 30 mL (1,000 USP units per mL) NDC 63323-540-33 30 mL multiple-dose, flip-top vial 926206 NDC 63323-262-06 Unit of 25 5,000 USP units per mL NDC 63323-262-03 1 mL fill in a 2 mL multiple-dose, flip-top vial 504213 NDC 63323-542-13 Unit of 25 10,000 USP units per mL NDC 63323-542-09 1 mL fill in a 2 mL multiple-dose, flip-top vial 504214 NDC 63323-542-14 Unit of 25 50,000 USP units per 5 mL (10,000 USP units per mL) NDC 63323-542-04 5 mL fill in a 10 mL multiple-dose, flip-top vial 915513 NDC 63323-915-13 Unit of 25 20,000 USP units per mL NDC 63323-915-03 1 mL fill in a 2 mL multiple-dose, flip-top 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 with natural rubber latex. STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 1 mL Multiple Dose Vial Label Not for Lock Flush NDC 63323-540-03 504013 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 Multiple Dose Vial Tray Label NDC 63323-540-13 504013 Heparin Sodium Injection, USP 1,000 USP units per mL For intravenous or subcutaneous use 1 mL 25 Vials PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 1 mL Multiple Dose Vial Label Not for Lock Flush NDC 63323-262-03 926206 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 Multiple Dose Vial Tray Label NDC 63323-262-06 926206 Heparin Sodium Injection, USP 5,000 USP units per mL For intravenous or subcutaneous use 1 mL 25 Vials PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 1 mL Multiple Dose Vial Label Not for Lock Flush NDC 63323-542-09 504213 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 Multiple Dose Vial Tray Label NDC 63323-542-13 504213 Heparin Sodium Injection, USP 10,000 USP units per mL For intravenous or subcutaneous use 1 mL 25 Vials PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 1 mL Multiple Dose Vial Label Not for Lock Flush NDC 63323-915-03 915513 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 Multiple Dose Vial Tray Label NDC 63323-915-13 915513 Heparin Sodium Injection, USP 20,000 USP units per mL For intravenous or subcutaneous use 1 mL 25 Vials PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 0.5 mL Single Dose Vial Label Not for Lock Flush NDC 63323-543-03 504313 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 63323-543-13 504313 Heparin Sodium Injection, USP 5,000 USP units per 0.5 mL For intravenous or subcutaneous use Preservative Free 25 Vials hepar-label-01.jpg hepar-label-02.jpg hepar-label-03.jpg hepar-label-04.jpg hepar-label-05.jpg hepar-label-06.jpg hepar-label-07.jpg hepar-label-08.jpg hepar-label-09.jpg hepar-label-10.jpg
  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 10 mL Multiple Dose Vial Label NDC 63323-540-05 504015 Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For intravenous or subcutaneous use hepar-label-11.jpg
  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 10 mL Multiple Dose Vial Tray Label NDC 63323-540-15 504015 Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For intravenous or subcutaneous use 25 Vials hepar-label-12.jpg
  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 30 mL Multiple Dose Vial Label NDC 63323-540-33 504036 Heparin Sodium Injection, USP 30,000 USP units per 30 mL (1,000 USP units per mL) For intravenous or subcutaneous use hepar-label-13.jpg
  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 30 mL Multiple Dose Vial Tray Label NDC 63323-540-36 504036 Heparin Sodium Injection, USP 30,000 USP units per 30 mL (1,000 USP units per mL) For intravenous or subcutaneous use 25 Vials hepar-label-14.jpg
  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 5 mL Multiple Dose Vial Label NDC 63323-542-04 504214 Heparin Sodium Injection, USP 50,000 USP units per 5 mL (10,000 USP units per mL) For intravenous or subcutaneous use hepar-label-15.jpg
  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Heparin 5 mL Multiple Dose Vial Tray Label NDC 63323-542-14 504214 Heparin Sodium Injection, USP 50,000 USP units per 5 mL (10,000 USP units per mL) For intravenous or subcutaneous use 25 Vials hepar-label-16.jpg
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"}