Dynarex Antifungal Powder

Product NDC
67777-316
11-digit product format
677770316
Labeler code
67777
Product ID
67777-316_eea010c2-1949-029c-e053-2a95a90ad4cf
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole
Dosage form
POWDER
Route
TOPICAL
Labeler
Dynarex Corporation
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-05-19
Marketing end
0000-00-00
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-316-01Dynarex Antifungal Powder85 g in 1 BOTTLE, PLASTICPOWDER854
67777-316-02Dynarex Antifungal Powder24 in 1 CASEPOWDER244

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-316-01GM - Gram67777-316db071d52-757d-4998-92af-29bc292f9f3c12023-08-08
67777-316-02GM - Gram67777-316a8c09071-27c4-490e-8bcc-707949709a4512023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-316DYNAREX ANTIFUNGAL POWDER (MICONAZOLE) POWDER [DYNAREX CORPORATION]4Legacy NDC, 2 package rows20241122_1e335cf8-eb08-40b4-abad-7a71bd2283d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSN1e335cf8-eb08-40b4-abad-7a71bd2283d74
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD1e335cf8-eb08-40b4-abad-7a71bd2283d74
998461miconazole nitrate 2 % Topical PowderSY1e335cf8-eb08-40b4-abad-7a71bd2283d74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-316-016777703160185 g in 1 BOTTLE, PLASTIC (67777-316-01) 85 g2016-05-190000-00-00NoNoCurrent
67777-316-026777703160224 BOTTLE, PLASTIC in 1 CASE (67777-316-02) > 85 g in 1 BOTTLE, PLASTIC (67777-316-01) 2016-05-190000-00-00NoNoCurrent