FDA.reportPublic FDA data

Micafungin

Product NDC
70771-1684
11-digit product format
707711684
Labeler code
70771
Product ID
70771-1684_6d0bfa2b-cc2e-4759-988c-543631badfa4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Micafungin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Zydus Lifesciences Limited
Application
ANDA215241
Marketing category
ANDA
Marketing start
2023-04-10
Substance
MICAFUNGIN SODIUM
Active strength
20 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
IngredientStrength
MICAFUNGIN SODIUM20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIS1UP79R56
Rxcui861379, 861383

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04f262d4-f446-4cf7-b4fa-28b038cd7ee4Product name720260113
9c331f34-aa42-465c-8abd-4e929fba4e94Product name120250625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1684-1Micafungin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,13
70771-1684-1Micafungin5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,53
70771-1684-6Micafungin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,103
70771-1684-6Micafungin5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1684MICAFUNGIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS LIFESCIENCES LIMITED]2Current NDC, 4 package rows20240918_72bc5dd6-6052-4483-9b13-afdeaaa8cc69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861383micafungin sodium 100 MG InjectionPSN72bc5dd6-6052-4483-9b13-afdeaaa8cc693
861379micafungin sodium 50 MG InjectionPSN72bc5dd6-6052-4483-9b13-afdeaaa8cc693
861383micafungin 100 MG InjectionSCD72bc5dd6-6052-4483-9b13-afdeaaa8cc693
861379micafungin 50 MG InjectionSCD72bc5dd6-6052-4483-9b13-afdeaaa8cc693
861383micafungin 100 MG (equivalent to micafungin sodium 101.73 MG) InjectionSY72bc5dd6-6052-4483-9b13-afdeaaa8cc693
861379micafungin 50 MG (equivalent to micafungin sodium 50.86 MG) InjectionSY72bc5dd6-6052-4483-9b13-afdeaaa8cc693

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1684-1707711684011 VIAL in 1 CARTON (70771-1684-1) / 5 mL in 1 VIAL1 vial2024-08-20NoNoHistorical
70771-1684-67077116840610 VIAL in 1 CARTON (70771-1684-6) / 5 mL in 1 VIAL10 vial2023-04-10NoNoHistorical