Prescription drug · ANDA
Micafungin (Micafungin sodium) NDC 71288-028
Micafungin sodium 50 mg/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Meitheal Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71288-028-11 | 7128800281171288002811 | 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-028-11) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-028-10)Marketed from Sep 28, 2022 | |
| 71288-028-12 | 7128800281271288002812 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-028-12) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-028-10)Marketed from Nov 1, 2024 |
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 — 50 mg/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Meitheal Pharmaceuticals Inc.NDC labeler code 71288
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215381
- Marketing start
- Listing expires
- Other FDA classes
- Lipopeptides (Chemical structure)
- Identifiers
- Product ID 71288-028_9571440f-2c9b-4281-b907-0d53408d744eSPL ID 9571440f-2c9b-4281-b907-0d53408d744eSPL set ID 579ff093-0359-4e0e-a6ea-2b6adac80bf0RxCUI 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
N471288002811followed by a unit qualifier and the quantityPackage 71288-0028-11. 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 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 patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies ( 14.3 )]. Micafungin for Injection is an echinocandin indicated in adult and pediatric patients for ( 1 ): Treatment of Candidemia, Acute Diss…
Excerpt only. Read the full label for complete information.
About NDC 71288-028
- What is NDC 71288-028?
- 71288-028 is the product NDC for Micafungin (micafungin sodium), Micafungin sodium 50 mg/5mL injection, powder, lyophilized, for solution, listed with the FDA by Meitheal Pharmaceuticals Inc.. It has 2 package NDCs, 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?
- Meitheal Pharmaceuticals Inc., NDC labeler code 71288. 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 215381
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 100 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-029 |