Mycamine
- Product NDC
- 0469-3250
- 11-digit product format
- 004693250
- Labeler code
- 0469
- Product ID
- 0469-3250_9c5e9ccb-1ded-4c6a-8781-4d25e6f41299
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Micafungin sodium
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Astellas Pharma US, Inc.
- Application
- NDA021506
- Marketing category
- NDA
- Marketing start
- 2005-03-16
- Marketing end
- 2026-09-30
- Substance
- MICAFUNGIN SODIUM
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Echinocandin Antifungal [EPC], Lipopeptides [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mycamine
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MICAFUNGIN SODIUM | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IS1UP79R56 |
| Rxcui | 861379, 861381, 861383, 861385 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0469-3250-10 | Mycamine | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 5 | | 19 |
| 0469-3250-10 | Mycamine | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 19 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MICAFUNGIN SODIUM | ACTIVE INGREDIENT | IS1UP79R56 | MYCAMINE (MICAFUNGIN SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTELLAS PHARMA US, INC.] | 9 | |
| MICAFUNGIN | ACTIVE MOIETY | R10H71BSWG | MYCAMINE (MICAFUNGIN SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTELLAS PHARMA US, INC.] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0469-3250 | MYCAMINE (MICAFUNGIN SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTELLAS PHARMA US, INC.] | 18 | Current NDC, Legacy NDC, 2 package rows | 20250101_a064c4a7-25ec-4a2c-afc2-703491a4a38b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0469-3250-10 | 00469325010 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0469-3250-10) / 5 mL in 1 VIAL, SINGLE-DOSE | 2005-03-16 | 2026-09-30 | No | No | Current |
| 0469-3250-50 | 00469325050 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0469-3250-50) > 5 mL in 1 VIAL, SINGLE-DOSE | 2014-12-01 | 0000-00-00 | No | No | Current |