FDA.reportPublic FDA data

Astonea Miconazole nitrate

Product NDC
77338-165
Requested package NDC
77338-165-03
11-digit product format
773380165
Labeler code
77338
Product ID
77338-165_e69cd379-fdb4-b737-e053-2995a90aba3e
Type
HUMAN OTC DRUG
Nonproprietary name
Antifungal
Dosage form
POWDER
Route
TOPICAL
Labeler
ASTONEA LABS PRIVATE LIMITED
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-08-19
Marketing end
0000-00-00
Substance
MICONAZOLE NITRATE
Active strength
2 g/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage77338-16577338-165-03IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage77338-16577338-165-03IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage77338-16577338-165-03IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage77338-16577338-165-03IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77338-165-032024-06-25C16284748780-11030e365-6771-111a-e063-dadaa90a10e2Astonea Anti-Fungal Powder Talc
77338-165-032024-01-30C16284748780-11030e365-6771-111a-e063-dadaa90a10e2Astonea Anti-Fungal Powder Talc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-165-03Astonea Miconazole nitrate85 g in 1 BOTTLE, PLASTICPOWDER852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-165ASTONEA MICONAZOLE NITRATE (ANTIFUNGAL) POWDER [ASTONEA LABS PRIVATE LIMITED]2Legacy NDC, 1 package rows20240627_e69cd379-fdb2-b737-e053-2995a90aba3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSNe69cd379-fdb2-b737-e053-2995a90aba3e2
998461miconazole nitrate 0.02 MG/MG Topical PowderSCDe69cd379-fdb2-b737-e053-2995a90aba3e2
998461miconazole nitrate 2 % Topical PowderSYe69cd379-fdb2-b737-e053-2995a90aba3e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77338-165-037733801650385 g in 1 BOTTLE, PLASTIC (77338-165-03) 85 g2022-08-190000-00-00NoNoCurrent