Miconazole 3

Product NDC
59779-839
11-digit product format
597790839
Labeler code
59779
Product ID
59779-839_5f3e63c7-0aaa-4dbf-950b-5d11793f6577
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
KIT
Labeler
CVS Pharmacy
Application
ANDA076357
Marketing category
ANDA
Marketing start
2014-02-28
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui992816, 998483, 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
59779-839-00Miconazole 31 in 1 CARTONKIT17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-839-00GM - Gram59779-8393d579a53-ce8c-4c17-8cf1-fb970cc1a0f412017-10-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]2
MICONAZOLEACTIVE MOIETY7NNO0D7S5MMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]2
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]2
PEG-5 OLEATEINACTIVE INGREDIENT0240V77G50MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]2
PEGOXOL 7 STEARATEINACTIVE INGREDIENT3EW5AXE5X5MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]2
WATERINACTIVE INGREDIENT059QF0KO0RMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-839MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]7Current NDC, Legacy NDC, 1 package rows20250430_9f506f59-e435-465d-90c7-9b0edc44160d.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) } PackGPCK9f506f59-e435-465d-90c7-9b0edc44160d7
992816miconazole 3 Day - (4 % applicator 5 GM / 2 % cream 9 GM) PackPSN9f506f59-e435-465d-90c7-9b0edc44160d7
998483miconazole nitrate 2 % Topical CreamPSN9f506f59-e435-465d-90c7-9b0edc44160d7
998540miconazole nitrate 2 % Vaginal CreamPSN9f506f59-e435-465d-90c7-9b0edc44160d7
998544miconazole nitrate 4 % Vaginal CreamPSN9f506f59-e435-465d-90c7-9b0edc44160d7
998483miconazole nitrate 20 MG/ML Topical CreamSCD9f506f59-e435-465d-90c7-9b0edc44160d7
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD9f506f59-e435-465d-90c7-9b0edc44160d7
998544miconazole nitrate 40 MG/ML Vaginal CreamSCD9f506f59-e435-465d-90c7-9b0edc44160d7
992816{3 (5 GM miconazole nitrate 200 MG (4 % ) Prefilled Applicator) / 1 (9 GM miconazole nitrate 2 % Vaginal Cream) } PackSY9f506f59-e435-465d-90c7-9b0edc44160d7
992816{3 (5000 MG miconazole nitrate 4 % Prefilled Applicator) / 1 (0.32 OZ miconazole nitrate 2 % Vaginal Cream) } PackSY9f506f59-e435-465d-90c7-9b0edc44160d7
992816Miconazole 3 Day Prefilled Applicator Combination PackSY9f506f59-e435-465d-90c7-9b0edc44160d7
998483miconazole nitrate 2 % Topical CreamSY9f506f59-e435-465d-90c7-9b0edc44160d7
998540miconazole nitrate 2 % Vaginal CreamSY9f506f59-e435-465d-90c7-9b0edc44160d7
998544miconazole nitrate 4 % Vaginal CreamSY9f506f59-e435-465d-90c7-9b0edc44160d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-839-00597790839001 KIT in 1 CARTON (59779-839-00) * 1 APPLICATOR in 1 POUCH / 5 g in 1 APPLICATOR * 1 TUBE in 1 CARTON / 9 g in 1 TUBE1 kit2014-02-280000-00-00NoNoCurrent