Prescription drug · NDA AUTHORIZED GENERIC
Enoxaparin Sodium NDC 63323-609
Enoxaparin sodium 120 mg/.8mL · Injection · Subcutaneous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-609-98 | 63323060998 | 10 CELLO PACK in 1 CARTON (63323-609-98) / 1 SYRINGE in 1 CELLO PACK (63323-609-08) / .8 mL in 1 SYRINGEMarketed from Jun 18, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Enoxaparin Sodium
- Generic name (nonproprietary)
- enoxaparin sodium
- Active ingredients
- Enoxaparin sodium — 120 mg/.8mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020164
- Marketing start
- Listing expires
- Other FDA classes
- Low-Molecular-Weight (Chemical structure)
- Identifiers
- Product ID 63323-609_a12d41f8-475d-4932-9aa0-73180eb1fd60SPL ID a12d41f8-475d-4932-9aa0-73180eb1fd60SPL set ID 066f27ec-352c-4051-ba29-248e292690dbRxCUI 854228, 854235, 854238, 854241, 854245, 854248, 854252, 854255UNII 8NZ41MIK1O
- Pharmacologic class
- Low Molecular Weight 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
N463323060998followed by a unit qualifier and the quantityPackage 63323-0609-98. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Enoxaparin sodium is a low molecular weight heparin (LMWH) indicated for: Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness ( 1.1 ) Inpatient treatment of acute DVT with or without pulmonary embolism ( 1.2 ) Outpatient treatment of acute DVT without pulmonary embolism ( 1.2 ) Prophylaxis of ischemic complications of unstable angina and non–Q-wave myocardial infarction (MI) ( 1.3 ) Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) ( 1.4 ) 1.1 Prophylaxis of D…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020164
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 |
|---|---|---|---|---|
| Lovenoxenoxaparin sodium | Enoxaparin sodium 150 mg/mL | InjectionSubcutaneous | Sanofi-Aventis U.S. LLC | 0075-2915 |
| Enoxaparin sodium | Enoxaparin sodium 100 mg/mL | InjectionSubcutaneous | Sanofi-Aventis U.S. LLC | 0955-1010 |
| Enoxaparin Sodium | Enoxaparin sodium 100 mg/mL | InjectionSubcutaneous | Fresenius Kabi USA, LLC | 63323-605 |
| Lovenoxenoxaparin sodium | Enoxaparin sodium 80 mg/.8mL | InjectionSubcutaneous | Sanofi-Aventis U.S. LLC | 0075-0622 |
| Enoxaparin Sodium | Enoxaparin sodium 100 mg/mL | InjectionSubcutaneous | Fresenius Kabi USA, LLC | 63323-605 |
| Enoxaparin Sodium | Enoxaparin sodium 60 mg/.6mL | InjectionSubcutaneous | Fresenius Kabi USA, LLC | 63323-607 |
| Enoxaparin Sodium | Enoxaparin sodium 60 mg/.6mL | InjectionSubcutaneous | Fresenius Kabi USA, LLC | 63323-607 |
| Enoxaparin sodium | Enoxaparin sodium 40 mg/.4mL | InjectionSubcutaneous | Sanofi-Aventis U.S. LLC | 0955-1004 |
| Lovenoxenoxaparin sodium | Enoxaparin sodium 40 mg/.4mL | InjectionSubcutaneous | Sanofi-Aventis U.S. LLC | 0075-8014 |
| Enoxaparin sodium | Enoxaparin sodium 60 mg/.6mL | InjectionSubcutaneous | Sanofi-Aventis U.S. LLC | 0955-1006 |
| Enoxaparin sodium | Enoxaparin sodium 80 mg/.8mL | InjectionSubcutaneous | Sanofi-Aventis U.S. LLC | 0955-1008 |
| Lovenoxenoxaparin sodium | Enoxaparin sodium 40 mg/.4mL | InjectionSubcutaneous | Sanofi-Aventis U.S. LLC | 0075-0620 |
| Lovenoxenoxaparin sodium | Enoxaparin sodium 40 mg/.4mL | InjectionSubcutaneous | Cardinal Health 107, LLC | 55154-4028 |
| Enoxaparin sodium | Enoxaparin sodium 120 mg/.8mL | InjectionSubcutaneous | Sanofi-Aventis U.S. LLC | 0955-1012 |
| Lovenoxenoxaparin sodium | Enoxaparin sodium 150 mg/mL | InjectionSubcutaneous | Sanofi-Aventis U.S. LLC | 0075-8025 |
| Enoxaparin sodium | Enoxaparin sodium 150 mg/mL | InjectionSubcutaneous | Sanofi-Aventis U.S. LLC | 0955-1015 |
| Enoxaparin sodium | Enoxaparin sodium 300 mg/3mL | InjectionSubcutaneous | Sanofi-Aventis U.S. LLC | 0955-1016 |
| Lovenoxenoxaparin sodium | Enoxaparin sodium 300 mg/3mL | InjectionIntravenous, Subcutaneous | Sanofi-Aventis U.S. LLC | 0075-0626 |
| Lovenoxenoxaparin sodium | Enoxaparin sodium 100 mg/mL | InjectionSubcutaneous | Sanofi-Aventis U.S. LLC | 0075-8020 |
| Lovenoxenoxaparin sodium | Enoxaparin sodium 100 mg/mL | InjectionSubcutaneous | Sanofi-Aventis U.S. LLC | 0075-0623 |
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