Prescription drug · NDA
Heparin Sodium NDC 0641-6199
Heparin sodium 5000 [USP'U]/mL · Injection · Intravenous, Subcutaneous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0641-6199-10 | 0064161991000641619910 | 10 SYRINGE, GLASS in 1 CARTON (0641-6199-10) / 1 mL in 1 SYRINGE, GLASS (0641-6199-01)Marketed from May 19, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Heparin Sodium
- Generic name (nonproprietary)
- heparin sodium
- Active ingredients
- Heparin sodium — 5000 [USP'U]/mL
- Dosage form
- Injection
- Route
- Intravenous, Subcutaneous
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0641
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017037
- Marketing start
- Listing expires
- Other FDA classes
- Heparin (Chemical structure)
- Identifiers
- Product ID 0641-6199_3d3993a7-2f8d-4124-9065-1759b0d98aafSPL ID 3d3993a7-2f8d-4124-9065-1759b0d98aafSPL set ID 7014808d-cec9-4b2c-8eb5-940493e356abRxCUI 1361226, 1361615, 1362831, 1659263, 1798389, 2121591UNII ZZ45AB24CA
- 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.
- NDC on a medical claim
N400641619910followed by a unit qualifier and the quantityPackage 00641-6199-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Heparin Sodium Injection is indicated for: Prophylaxis and treatment of venous thrombosis and pulmonary embolism; 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; 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 arterial embolism. Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. HEPARIN SODIUM INJECTION is an an…
Excerpt only. Read the full label for complete information.
About NDC 0641-6199
- What is NDC 0641-6199?
- 0641-6199 is the product NDC for Heparin Sodium, Heparin sodium 5000 [USP'U]/mL injection, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Heparin Sodium.
- What is the active ingredient?
- Heparin sodium.
- Who is the labeler?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0641. 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 017037
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 | InjectionIntravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0641-0391 |
| Heparin Sodium | Heparin sodium 5000 [USP'U]/mL | InjectionIntravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0641-0400 |
| Heparin Sodium | Heparin sodium 10000 [USP'U]/mL | InjectionIntravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0641-0410 |
| Heparin Sodium | Heparin sodium 5000 [USP'U]/.5mL | InjectionIntravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0641-6204 |
| Heparin Sodium | Heparin sodium 5000 [USP'U]/mL | InjectionIntravenous, Subcutaneous | Cardinal Health 107, LLC | 55154-5130 |
| Heparin Sodium | Heparin sodium 5000 [USP'U]/mL | InjectionIntravenous, Subcutaneous | REMEDYREPACK INC. | 70518-4547 |
| Heparin Sodium | Heparin sodium 1000 [USP'U]/mL | InjectionIntravenous, Subcutaneous | Civica, Inc. | 72572-250 |
| Heparin Sodium | Heparin sodium 5000 [USP'U]/mL | InjectionIntravenous, Subcutaneous | Civica, Inc. | 72572-255 |