Mycamine
- Product NDC
- 0469-3211
- 11-digit product format
- 004693211
- Labeler code
- 0469
- Product ID
- 0469-3211_493fca15-59d0-4944-b204-f5978895e182
- 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
- 2014-12-01
- Marketing end
- 2023-01-31
- Substance
- MICAFUNGIN SODIUM
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Echinocandin Antifungal [EPC], Lipopeptides [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0469-3211-10 | Mycamine | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 10 | | 19 |
| 0469-3211-10 | 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 |
|---|
| 0469-3211 | MYCAMINE (MICAFUNGIN SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTELLAS PHARMA US, INC.] | 18 | 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 |
|---|
| 0469-3211-10 | 00469321110 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0469-3211-10) > 10 mL in 1 VIAL, SINGLE-DOSE | 2006-06-27 | 0000-00-00 | No | No | Current |
| 0469-3211-99 | 00469321199 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0469-3211-99) > 10 mL in 1 VIAL, SINGLE-DOSE | 2014-12-01 | 0000-00-00 | No | No | Current |