FDA.reportPublic FDA data

Leader Miconazole 3

Product NDC
70000-0669
11-digit product format
700000669
Labeler code
70000
Product ID
70000-0669_1c6314df-4429-4d58-bdc2-12830d55f036
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
KIT
Labeler
Cardinal Health 110, LLC. dba Leader
Application
ANDA076357
Marketing category
ANDA
Marketing start
2024-06-27
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Leader Miconazole 3
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui992816, 998540, 998544

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-7198-00Leader Miconazole 35 g in 1 APPLICATORCREAM15 g4 g in 100g2
0113-7198-00Leader Miconazole 31 in 1 POUCHCREAM4 g in 100g2
0113-8123-00Leader Miconazole 31 in 1 CARTONCREAM2 g in 100g2
0113-8123-00Leader Miconazole 39 g in 1 TUBECREAM9 g2 g in 100g2
70000-0669-1Leader Miconazole 31 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0669LEADER MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [CARDINAL HEALTH 110, LLC. DBA LEADER]1Current NDC, 5 package rows20240711_7f6df893-f404-4b2d-ab2b-696c8a2d36fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992816{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (5000 MG) (miconazole nitrate 40 MG/ML Vaginal Cream) } PackGPCK7f6df893-f404-4b2d-ab2b-696c8a2d36fa2
992816miconazole 3 Day - (4 % applicator 5 GM / 2 % cream 9 GM) PackPSN7f6df893-f404-4b2d-ab2b-696c8a2d36fa2
998540miconazole nitrate 2 % Vaginal CreamPSN7f6df893-f404-4b2d-ab2b-696c8a2d36fa2
998544miconazole nitrate 4 % Vaginal CreamPSN7f6df893-f404-4b2d-ab2b-696c8a2d36fa2
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD7f6df893-f404-4b2d-ab2b-696c8a2d36fa2
998544miconazole nitrate 40 MG/ML Vaginal CreamSCD7f6df893-f404-4b2d-ab2b-696c8a2d36fa2
992816{3 (5 GM miconazole nitrate 200 MG (4 % ) Prefilled Applicator) / 1 (9 GM miconazole nitrate 2 % Vaginal Cream) } PackSY7f6df893-f404-4b2d-ab2b-696c8a2d36fa2
992816{3 (5000 MG miconazole nitrate 4 % Prefilled Applicator) / 1 (0.32 OZ miconazole nitrate 2 % Vaginal Cream) } PackSY7f6df893-f404-4b2d-ab2b-696c8a2d36fa2
992816Miconazole 3 Day Prefilled Applicator Combination PackSY7f6df893-f404-4b2d-ab2b-696c8a2d36fa2
998540miconazole nitrate 2 % Vaginal CreamSY7f6df893-f404-4b2d-ab2b-696c8a2d36fa2
998544miconazole nitrate 4 % Vaginal CreamSY7f6df893-f404-4b2d-ab2b-696c8a2d36fa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0113-7198-00001137198005 g in 1 APPLICATOR5 gHistorical
0113-8123-00001138123001 in 1 CARTONHistorical
70000-0669-1700000669011 KIT in 1 CARTON (70000-0669-1) * 1 APPLICATOR in 1 POUCH (0113-7198-00) / 5 g in 1 APPLICATOR * 1 TUBE in 1 CARTON (0113-8123-00) / 9 g in 1 TUBE1 kit2024-06-27NoNoHistorical