MICAFUNGIN
- Product NDC
- 68462-772
- 11-digit product format
- 684620772
- Labeler code
- 68462
- Product ID
- 68462-772_31e74606-bccd-4276-bb20-a1933ce4ca25
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Micafungin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA219273
- Marketing category
- ANDA
- Marketing start
- 2025-06-30
- Substance
- MICAFUNGIN
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Echinocandin Antifungal [EPC], Lipopeptides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MICAFUNGIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MICAFUNGIN | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R10H71BSWG |
| Rxcui | 861379, 861383 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-772-01 | MICAFUNGIN | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 1 |
| 68462-772-01 | MICAFUNGIN | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | | 1 |
| 68462-772-10 | MICAFUNGIN | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 1 |
| 68462-772-10 | MICAFUNGIN | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68462-772-01 | 68462077201 | 1 VIAL in 1 CARTON (68462-772-01) / 5 mL in 1 VIAL | 1 vial | 2025-06-30 | No | No | Current |
| 68462-772-10 | 68462077210 | 10 VIAL in 1 CARTON (68462-772-10) / 5 mL in 1 VIAL | 10 vial | 2025-06-30 | No | No | Current |