FDA.reportPublic FDA data

Micafungin

Product NDC
42658-022
Requested package NDC
42658-022-01
11-digit product format
426580022
Labeler code
42658
Product ID
42658-022_4f4d74bd-7d4e-0340-e063-6394a90aee8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Micafungin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hisun Pharmaceuticals USA, Inc.
Application
ANDA219712
Marketing category
ANDA
Marketing start
2026-04-01
Substance
MICAFUNGIN SODIUM
Active strength
50 mg/1
Pharmacologic classes
Echinocandin Antifungal [EPC], Lipopeptides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219712-001MICAFUNGIN SODIUMMICAFUNGIN SODIUMEQ 50MG BASE/VIALINJECTABLE / INTRAVENOUSAP2026-01-21
A219712-002MICAFUNGIN SODIUMMICAFUNGIN SODIUMEQ 100MG BASE/VIALINJECTABLE / INTRAVENOUSAP2026-01-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A219712-001AP
A219712-002AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A219712-001MICAFUNGIN SODIUMEQ 50MG BASE/VIALINJECTABLE / INTRAVENOUSAP2026-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219712-002MICAFUNGIN SODIUMEQ 100MG BASE/VIALINJECTABLE / INTRAVENOUSAP2026-01-21011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219712-001MICAFUNGIN SODIUMEQ 50MG BASE/VIALINJECTABLE / INTRAVENOUSAP2026-01-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219712-002MICAFUNGIN SODIUMEQ 100MG BASE/VIALINJECTABLE / INTRAVENOUSAP2026-01-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A219712-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219712-002AP1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219712-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219712-002AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Micafungin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICAFUNGIN SODIUM50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IS1UP79R56Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
861379Internal RxNorm lookup
861383Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
230fcff4-ad4b-ea25-e063-6394a90a1fabAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04f262d4-f446-4cf7-b4fa-28b038cd7ee4Product name720260113
9c331f34-aa42-465c-8abd-4e929fba4e94Product name120250625
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42658-022-01Micafungin1 in 1 BOXINJECTION, POWDER, FOR SOLUTION16
42658-022-01Micafungin1 in 1 VIALINJECTION, POWDER, FOR SOLUTION16
42658-022-02Micafungin10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION106
42658-022-02Micafungin1 in 1 BOXINJECTION, POWDER, FOR SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42658-022-01EA - Each42658-022d4a25724-e95f-4bf3-90fe-8d74d76aaf0b12026-04-20
42658-022-02EA - Each42658-0224ec27adc-6103-4198-9260-10bb77441b7112026-04-20

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MicafunginMICAFUNGINHisun Pharmaceuticals USA, Inc.230fcff4-ad4b-ea25-e063-6394a90a1fab2026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219712
application number: ANDA219712
ndc (package): 42658-022-01
ndc (product): 42658-022
ndc11 (package): 42658002201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861383micafungin sodium 100 MG InjectionPSN230fcff4-ad4b-ea25-e063-6394a90a1fab6
861379micafungin sodium 50 MG InjectionPSN230fcff4-ad4b-ea25-e063-6394a90a1fab6
861383micafungin 100 MG InjectionSCD230fcff4-ad4b-ea25-e063-6394a90a1fab6
861379micafungin 50 MG InjectionSCD230fcff4-ad4b-ea25-e063-6394a90a1fab6
861383micafungin 100 MG (equivalent to micafungin sodium 101.73 MG) InjectionSY230fcff4-ad4b-ea25-e063-6394a90a1fab6
861379micafungin 50 MG (equivalent to micafungin sodium 50.86 MG) InjectionSY230fcff4-ad4b-ea25-e063-6394a90a1fab6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42658-022-01426580022011 VIAL in 1 BOX (42658-022-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL1 vial2026-04-01NoNoCurrent