MICAFUNGIN
- Product NDC
- 67184-0589
- 11-digit product format
- 671840589
- Labeler code
- 67184
- Product ID
- 67184-0589_0f106cca-1588-4f13-a833-662676fc85c8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Micafungin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Qilu Pharmaceutical Co., Ltd
- Application
- ANDA219273
- Marketing category
- ANDA
- Marketing start
- 2025-04-03
- Substance
- MICAFUNGIN
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Echinocandin Antifungal [EPC], Lipopeptides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MICAFUNGIN
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MICAFUNGIN | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R10H71BSWG |
| Rxcui | 861379, 861383 |
DailyMed Product Concepts#
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67184-0589-1 | 67184058901 | 1 VIAL in 1 CARTON (67184-0589-1) / 5 mL in 1 VIAL | 1 vial | 2025-04-03 | No | No | Historical |
| 67184-0589-2 | 67184058902 | 10 VIAL in 1 CARTON (67184-0589-2) / 5 mL in 1 VIAL | 10 vial | 2025-04-03 | No | No | Historical |