MICAFUNGIN
- Product NDC
- 70377-075
- 11-digit product format
- 703770075
- Labeler code
- 70377
- Product ID
- 70377-075_94972438-1ece-f99c-c2a5-e29821e7e9d4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- micafungin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Biocon Pharma Inc.
- Application
- ANDA216438
- Marketing category
- ANDA
- Marketing start
- 2025-06-01
- Substance
- MICAFUNGIN SODIUM
- Active strength
- 10 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 SODIUM | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IS1UP79R56 |
| Rxcui | 861379, 861383 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70377-075-91 | MICAFUNGIN | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 5 |
| 70377-075-91 | MICAFUNGIN | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 5 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70377-075 | MICAFUNGIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BIOCON PHARMA INC.] | 4 | Current NDC, 2 package rows | 20241102_5a74d7e9-1ca2-37dd-cbcf-d7fde1f5a606.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70377-075-91 | 70377007591 | 10 VIAL, SINGLE-DOSE in 1 CARTON (70377-075-91) / 5 mL in 1 VIAL, SINGLE-DOSE | 2025-06-01 | No | No | Historical |