Prescription drug · NDA
Heparin Sodium NDC 63323-459
Heparin sodium 10000 [USP'U]/mL · Injection, Solution · Intravenous, Subcutaneous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Heparin Sodium
- Generic name (nonproprietary)
- heparin sodium
- Active ingredients
- Heparin sodium — 10000 [USP'U]/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous, Subcutaneous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017029
- Marketing start
- Listing expires
- Other FDA classes
- Heparin (Chemical structure)
- Identifiers
- Product ID 63323-459_529104c9-6154-4428-953d-5546875f32e5SPL ID 529104c9-6154-4428-953d-5546875f32e5SPL set ID d55b4a63-0c04-4874-b74f-9e9b9e8b008cRxCUI 1361226, 1361574, 1361615, 1362831, 1658634, 1658647UNII ZZ45AB24CAUPC 0363323276010, 0363323047016, 0363323543020
- Pharmacologic class
- Anti-coagulant; Unfractionated Heparin
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Heparin Sodium Injection is indicated for: Anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension; Low-dose regimen for prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease (see DOSAGE AND ADMINISTRATION ); Prophylaxis and treatment of pulmonary embolism; Atrial fibrillation with embolization; Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); Prevention of clotting in arterial and cardiac surgery; Prophylaxis and treatment of peripheral a…
Excerpt only. Read the full label for complete information.
About NDC 63323-459
- What is NDC 63323-459?
- 63323-459 is the product NDC for Heparin Sodium, Heparin sodium 10000 [USP'U]/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC.
- What drug is associated with this NDC?
- Heparin Sodium.
- What is the active ingredient?
- Heparin sodium.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Heparin Sodium?
- 118 other product NDCs are listed under this name. See all Heparin Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Heparin Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Heparin Sodium | Heparin sodium 5000 [USP'U]/.5mL | Injection, SolutionIntravenous, Subcutaneous | Cardinal Health 107, LLC | 55154-9589 | 55154-9589-05 |
| Heparin Sodium | Heparin sodium 5000 [USP'U]/mL | InjectionIntravenous, Subcutaneous | REMEDYREPACK INC. | 70518-4547 | 70518-4547-00 |
| Heparin Sodium | Heparin sodium 10000 [USP'U]/mL | InjectionIntravenous, Subcutaneous | Meitheal Pharmaceuticals Inc. | 71288-451 | 71288-0451-02 |
| Heparin Sodium | Heparin sodium 1000 [USP'U]/mL | InjectionIntravenous, Subcutaneous | Meitheal Pharmaceuticals Inc. | 71288-449 | 71288-0449-02 |
| Heparin Sodium | Heparin sodium 5000 [USP'U]/mL | InjectionIntravenous, Subcutaneous | Meitheal Pharmaceuticals Inc. | 71288-450 | 71288-0450-02 |
| Heparin Sodium | Heparin sodium 2000 [USP'U]/2mL | InjectionIntravenous, Subcutaneous | NorthStar RxLLC | 72603-336 | 72603-0336-25 |
| Heparin Sodium | Heparin sodium 5000 [USP'U]/mL | InjectionIntravenous, Subcutaneous | NorthStar RxLLC | 72603-412 | 72603-0412-25 |
| Heparin Sodium | Heparin sodium 10000 [USP'U]/mL | InjectionIntravenous, Subcutaneous | NorthStar RxLLC | 72603-501 | 72603-0501-25 |
| Heparin Sodium | Heparin sodium 1000 [USP'U]/mL | InjectionIntravenous, Subcutaneous | Medical Purchasing Solutions, LLC. | 71872-7351 | 71872-7351-01 |
| Heparin Sodium | Heparin sodium 1000 [USP'U]/mL | InjectionIntravenous, Subcutaneous | Medical Purchasing Solutions, LLC | 71872-7352 | 71872-7352-01 |
Other NDCs under NDA 017029
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Heparin Sodium | Heparin sodium 1000 [USP'U]/mL | Injection, SolutionIntravenous, Subcutaneous | Henry Schein, Inc. | 0404-9979 |
| Heparin Sodium | Heparin sodium 10000 [USP'U]/mL | Injection, SolutionIntravenous, Subcutaneous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1409 |
| Heparin Sodium | Heparin sodium 1000 [USP'U]/mL | Injection, SolutionIntravenous, Subcutaneous | Cardinal Health 107, LLC | 55154-9583 |
| Heparin Sodium | Heparin sodium 5000 [USP'U]/mL | Injection, SolutionIntravenous, Subcutaneous | Cardinal Health 107, LLC | 55154-9585 |
| Heparin Sodium | Heparin sodium 5000 [USP'U]/.5mL | Injection, SolutionIntravenous, Subcutaneous | Cardinal Health 107, LLC | 55154-9589 |
| Heparin Sodium | Heparin sodium 5000 [USP'U]/.5mL | Injection, SolutionIntravenous, Subcutaneous | Fresenius Kabi USA, LLC | 63323-118 |
| Heparin Sodium | Heparin sodium 5000 [USP'U]/mL | Injection, SolutionIntravenous, Subcutaneous | Fresenius Kabi USA, LLC | 63323-262 |
| Heparin Sodium | Heparin sodium 1000 [USP'U]/mL | Injection, SolutionIntravenous, Subcutaneous | Fresenius Kabi USA, LLC | 63323-276 |
| Heparin Sodium | Heparin sodium 10000 [USP'U]/100mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-517 |
| Heparin Sodium | Heparin sodium 5000 [USP'U]/100mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-518 |
| Heparin Sodium | Heparin sodium 5000 [USP'U]/100mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-522 |
| Heparin Sodium | Heparin sodium 10000 [USP'U]/100mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-523 |
| Heparin Sodium | Heparin sodium 1000 [USP'U]/mL | Injection, SolutionIntravenous, Subcutaneous | Fresenius Kabi USA, LLC | 63323-540 |
| Heparin Sodium | Heparin sodium 10000 [USP'U]/mL | Injection, SolutionIntravenous, Subcutaneous | Fresenius Kabi USA, LLC | 63323-542 |
| Heparin Sodium | Heparin sodium 5000 [USP'U]/.5mL | Injection, SolutionIntravenous, Subcutaneous | Fresenius Kabi USA, LLC | 63323-543 |
| Heparin Sodium | Heparin sodium 20000 [USP'U]/mL | Injection, SolutionIntravenous, Subcutaneous | Fresenius Kabi USA, LLC | 63323-915 |
| Heparin Sodium | Heparin sodium 1000 [USP'U]/mL | Injection, SolutionIntravenous, Subcutaneous | Fresenius Kabi USA, LLC | 65219-066 |
| Heparin Sodium | Heparin sodium 1000 [USP'U]/mL | Injection, SolutionIntravenous, Subcutaneous | Phlow Corporation | 81565-203 |
| Heparin Sodium In Sodium Chloride | Heparin sodium 10000 [USP'U]/100mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1578 |