NDC 63323-543

Heparin Sodium

Heparin Sodium

Heparin Sodium is a Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Heparin Sodium.

• Product ID: 63323-543_2f22758f-1fa9-450c-bee9-568f12a1997f
• NDC: 63323-543
• Product Type: Human Prescription Drug
• Proprietary Name: Heparin Sodium
• Generic Name: Heparin Sodium
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS; SUBCUTANEOUS
• Marketing Start Date: 2019-11-04
• Marketing Category: NDA / NDA
• Application Number: NDA017029
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: HEPARIN SODIUM
• Active Ingredient Strength: 5000 [USP'U]/.5mL
• Pharm Classes: Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 63323-543-13

25 VIAL in 1 TRAY (63323-543-13) > .5 mL in 1 VIAL (63323-543-03)

• Marketing Start Date: 2019-11-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-543-02 [63323054302]

Heparin Sodium INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017029
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-11-22

NDC 63323-543-13 [63323054313]

Heparin Sodium INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017029
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-11-04

NDC 63323-543-03 [63323054303]

Heparin Sodium INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017029
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-11-04

Drug Details

Active Ingredients

Ingredient	Strength
HEPARIN SODIUM	5000 [USP'U]/.5mL

OpenFDA Data

• SPL SET ID: d55b4a63-0c04-4874-b74f-9e9b9e8b008c
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • ZZ45AB24CA
• RxNorm Concept Unique ID - RxCUI:
  • 1361615
  • 1361226
  • 1361574
  • 1658647
  • 1362831
  • 1658634
• UPC Code:
  • 0363323543020
  • 0363323276027

Pharmacological Class

• Anti-coagulant [EPC]
• Heparin [CS]
• Unfractionated Heparin [EPC]

NDC Crossover Matching brand name "Heparin Sodium" or generic name "Heparin Sodium"

NDC	Brand Name	Generic Name
0069-0043	Heparin Sodium	Heparin Sodium
0069-0058	Heparin Sodium	Heparin Sodium
0069-0059	Heparin Sodium	Heparin Sodium
0069-0062	Heparin Sodium	Heparin Sodium
0069-0137	Heparin Sodium	Heparin Sodium
0264-5705	Heparin Sodium	Heparin Sodium
0409-7651	Heparin Sodium	Heparin Sodium
0409-7620	Heparin Sodium	Heparin Sodium
0409-7650	Heparin Sodium	Heparin Sodium
68083-136	Heparin Sodium	Heparin Sodium
76045-108	Heparin Sodium	Heparin Sodium
0641-0410	Heparin Sodium	Heparin Sodium
0641-0391	Heparin Sodium	Heparin Sodium
0641-0400	Heparin Sodium	Heparin Sodium
0641-2460	Heparin Sodium	Heparin Sodium
0641-2450	Heparin Sodium	Heparin Sodium
0781-3327	Heparin Sodium	Heparin Sodium
25021-403	Heparin Sodium	Heparin Sodium
25021-402	Heparin Sodium	Heparin Sodium
25021-400	Heparin Sodium	Heparin Sodium
25021-401	Heparin Sodium	Heparin Sodium
25021-404	Heparin Sodium	Heparin Sodium
48433-329	Heparin Sodium	Heparin Sodium
48433-330	Heparin Sodium	Heparin Sodium
52533-104	Heparin Sodium	Heparin Sodium
52533-125	Heparin Sodium	Heparin Sodium
52533-142	Heparin Sodium	Heparin Sodium
52533-148	Heparin Sodium	Heparin Sodium
52533-211	Heparin Sodium	Heparin Sodium
52533-096	Heparin Sodium	Heparin Sodium
52533-029	Heparin Sodium	Heparin Sodium
52584-540	Heparin Sodium	Heparin Sodium
52533-098	Heparin Sodium	Heparin Sodium
52533-215	Heparin Sodium	Heparin Sodium
52533-097	Heparin Sodium	Heparin Sodium
52533-100	Heparin Sodium	Heparin Sodium
52533-138	Heparin Sodium	Heparin Sodium
52533-106	Heparin Sodium	Heparin Sodium
52533-179	Heparin Sodium	Heparin Sodium
52533-216	Heparin Sodium	Heparin Sodium
52584-400	HEPARIN SODIUM	HEPARIN SODIUM
52584-262	Heparin Sodium	Heparin Sodium
52584-402	Heparin Sodium	Heparin Sodium
52584-542	Heparin Sodium	Heparin Sodium
55154-4749	Heparin Sodium	Heparin Sodium
55154-9354	Heparin Sodium	Heparin Sodium
55154-2827	Heparin Sodium	Heparin Sodium
0338-0424	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM
0338-0428	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM
0338-0431	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM