Micafungin
- Product NDC
- 63323-729
- 11-digit product format
- 633230729
- Labeler code
- 63323
- Product ID
- 63323-729_e8fcf6a2-1a58-4a13-9290-1fc0d4fecfd1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Micafungin Sodium
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA207344
- Marketing category
- ANDA
- Marketing start
- 2020-05-08
- Substance
- MICAFUNGIN SODIUM
- Active strength
- 100 mg/1
- 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IS1UP79R56 |
| Rxcui | 861383 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-729-01 | Micafungin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 7 |
| 63323-729-01 | Micafungin | 1 in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 7 |
| 63323-729-10 | Micafungin | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 7 |
| 63323-729-02 | Micafungin | 1 in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
| 63323-729-02 | Micafungin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
| 63323-729-12 | Micafungin | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-729 | MICAFUNGIN (MICAFUNGIN SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 6 | Current NDC, Legacy NDC, 3 package rows | 20241022_dc5241be-4b85-4f04-8553-9819603373b8.zip |
| 63323-729 | MICAFUNGIN (MICAFUNGIN SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 2 | Current NDC, Legacy NDC, 3 package rows | 20241022_f8198836-4011-40b9-af25-466ae08727f8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63323-729-01 | 63323072901 | 1 in 1 CARTON | | | | | | Historical |
| 63323-729-02 | 63323072902 | 1 in 1 VIAL, SINGLE-DOSE | | | | | | Historical |
| 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-DOSE | 10 carton | 2020-05-08 | 0000-00-00 | No | No | Current |
| 63323-729-12 | 63323072912 | 10 CARTON in 1 CARTON (63323-729-12) / 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-729-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE | 10 carton | 2020-05-08 | 0000-00-00 | No | No | Current |