Prescription drug · ANDA
Caspofungin Acetate NDC 0781-3421
Caspofungin acetate 5 mg/mL · Injection, Powder, Lyophilized, For solution · Intravenous · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-3421-94 | 0078134219400781342194 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3421-94) / 10.8 mL in 1 VIAL, SINGLE-DOSE (0781-3421-01)Marketed from Sep 4, 2018 |
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)
- Caspofungin Acetate
- Generic name (nonproprietary)
- caspofungin acetate
- Active ingredients
- Caspofungin acetate — 5 mg/mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Sandoz IncNDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200833
- Marketing start
- Listing expires
- Other FDA classes
- Lipopeptides (Chemical structure)
- Identifiers
- Product ID 0781-3421_d70d52c0-6601-f632-e053-2995a90a9291SPL ID d70d52c0-6601-f632-e053-2995a90a9291SPL set ID 722facc6-d4ea-4975-b83e-3ae63df69ed2RxCUI 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
N400781342194followed by a unit qualifier and the quantityPackage 00781-3421-94. 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 infecti…
Excerpt only. Read the full label for complete information.
About NDC 0781-3421
- What is NDC 0781-3421?
- 0781-3421 is the product NDC for Caspofungin Acetate, Caspofungin acetate 5 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Caspofungin Acetate.
- What is the active ingredient?
- Caspofungin acetate.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Caspofungin Acetate?
- 11 other product NDCs are listed under this name. See all Caspofungin Acetate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Caspofungin Acetate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Caspofungin Acetate | Caspofungin acetate 7 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | 65897-0004 | 65897-0004-01 |
| Caspofungin Acetate | Caspofungin acetate 5 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | 65897-0002 | 65897-0002-01 |
| Caspofungin Acetate | Caspofungin acetate 5 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Sagent Pharmaceuticals | 25021-194 | 25021-0194-10 |
| Caspofungin Acetate | Caspofungin acetate 7 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Sagent Pharmaceuticals | 25021-195 | 25021-0195-10 |
| Caspofungin Acetate | Caspofungin acetate 5 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Fosun Pharma USA Inc. | 72266-106 | 72266-0106-01 |
| Caspofungin Acetate | Caspofungin acetate 7 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Fosun Pharma USA Inc. | 72266-107 | 72266-0107-01 |
| Caspofungin Acetate | Caspofungin acetate 7 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Sandoz Inc | 0781-3423 | 00781-3423-94 |
| Caspofungin Acetate | Caspofungin acetate 5 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Gland Pharma Limited | 68083-158 | 68083-0158-01 |
| Caspofungin Acetate | Caspofungin acetate 7 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Gland Pharma Limited | 68083-159 | 68083-0159-01 |
| Caspofungin Acetate | Caspofungin acetate 5 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Fresenius Kabi USA, LLC | 63323-356 | 63323-0356-10 |
Other NDCs under ANDA 200833
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 7 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Sandoz Inc | 0781-3423 |