Prescription drug · ANDA
Caspofungin Acetate NDC 68083-158
Caspofungin acetate 5 mg/mL · Injection, Powder, Lyophilized, For solution · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-158-01 | 68083015801 | 1 VIAL in 1 CARTON (68083-158-01) / 10 mL in 1 VIALMarketed from Oct 29, 2017 |
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)
- Caspofungin Acetate
- Generic name (nonproprietary)
- caspofungin acetate
- Active ingredients
- Caspofungin acetate — 5 mg/mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Gland Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207092
- Marketing start
- Listing expires
- Other FDA classes
- Lipopeptides (Chemical structure)
- Identifiers
- Product ID 68083-158_0ebc13ad-ba33-408f-8af3-cf995efc4df2SPL ID 0ebc13ad-ba33-408f-8af3-cf995efc4df2SPL set ID 29da357e-e7fc-46af-bf20-806a1e4b5391RxCUI 828539, 828755UNII VUW370O5QE
- Pharmacologic class
- Echinocandin Antifungal
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
N468083015801followed by a unit qualifier and the quantityPackage 68083-0158-01. 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)
Caspofungin acetate for injection is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for: • Empirical therapy for presumed fungal infections in febrile, neutropenic patients. ( 1 ) • Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. ( 1 ) • Treatment of esophageal candidiasis. ( 1 ) • Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies. ( 1 ) 1.1 Empirical Therapy for Presumed Fungal Infections in Febrile, Neutropenic Patients Caspofungin acetate for injection is indicated as empirical therapy for presumed fungal…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207092
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 |
|---|---|---|---|---|
| Caspofungin Acetate | Caspofungin acetate 5 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Sagent Pharmaceuticals | 25021-194 |
| Caspofungin Acetate | Caspofungin acetate 7 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Sagent Pharmaceuticals | 25021-195 |
| Caspofungin Acetate | Caspofungin acetate 5 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Fosun Pharma USA Inc. | 72266-106 |
| Caspofungin Acetate | Caspofungin acetate 7 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Fosun Pharma USA Inc. | 72266-107 |
| Caspofungin Acetate | Caspofungin acetate 7 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Gland Pharma Limited | 68083-159 |