Prescription drug · ANDA
Micafungin (Micafungin sodium) NDC 63323-729
Micafungin sodium 100 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-729-10 | 63323072910 | 10 CARTON in 1 CARTON (63323-729-10) / 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-729-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from May 8, 2020 |
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)
- Micafungin
- Generic name (nonproprietary)
- micafungin sodium
- Active ingredients
- Micafungin sodium — 100 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207344
- Marketing start
- Listing expires
- Other FDA classes
- Lipopeptides (Chemical structure)
- Identifiers
- Product ID 63323-729_e9aa7e59-831f-4994-802b-b62221fdfca3SPL ID e9aa7e59-831f-4994-802b-b62221fdfca3SPL set ID dc5241be-4b85-4f04-8553-9819603373b8RxCUI 861379, 861383UNII IS1UP79R56
- 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
N463323072910followed by a unit qualifier and the quantityPackage 63323-0729-10. 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)
Micafungin for Injection is indicated for: • Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies ( 14.1 ) and Use in Specific Populations ( 8.4 )] . • Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see Use in Specific Populations ( 8.4 )] . • Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies ( 14.2 )] . • Prophylaxis of Candida Infections in adult and pediatric…
Excerpt only. Read the full label for complete information.
About NDC 63323-729
- What is NDC 63323-729?
- 63323-729 is the product NDC for Micafungin (micafungin sodium), Micafungin sodium 100 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Micafungin (Micafungin Sodium).
- What is the active ingredient?
- Micafungin 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 Micafungin?
- 19 other product NDCs are listed under this name. See all Micafungin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Micafungin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Micafungin | Micafungin sodium 50 mg/1 | Injection, Powder, For solutionIntravenous | Hisun Pharmaceuticals USA, Inc. | 42658-022 | 42658-0022-0142658-0022-02 |
| Micafungin | Micafungin sodium 100 mg/1 | Injection, Powder, For solutionIntravenous | Hisun Pharmaceuticals USA, Inc. | 42658-023 | 42658-0023-0142658-0023-02 |
| Micafungin | Micafungin 10 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Glenmark Pharmaceuticals Inc., USA | 68462-771 | 68462-0771-0168462-0771-10 |
| Micafungin | Micafungin 20 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Glenmark Pharmaceuticals Inc., USA | 68462-772 | 68462-0772-0168462-0772-10 |
| Micafungin | Micafungin sodium 10 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Biocon Pharma Inc. | 70377-075 | 70377-0075-91 |
| Micafungin | Micafungin sodium 20 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Biocon Pharma Inc. | 70377-076 | 70377-0076-91 |
| Micafungin | Micafungin 10 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Qilu Pharmaceutical Co., Ltd | 67184-0589 | 67184-0589-0167184-0589-02 |
| Micafungin | Micafungin 20 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Qilu Pharmaceutical Co., Ltd | 67184-0590 | 67184-0590-0167184-0590-02 |
| Micafungin | Micafungin sodium 10 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Zydus Pharmaceuticals USA Inc. | 70710-1724 | 70710-1724-0170710-1724-06 |
| Micafungin | Micafungin sodium 20 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Zydus Pharmaceuticals USA Inc. | 70710-1725 | 70710-1725-0170710-1725-06 |
Other NDCs under ANDA 207344
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 |
|---|---|---|---|---|
| Micafunginmicafungin sodium | Micafungin sodium 50 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Fresenius Kabi USA, LLC | 63323-728 |