FDA.reportPublic FDA data

miconazole 3

Product NDC
41250-081
11-digit product format
412500081
Labeler code
41250
Product ID
41250-081_5adbd32a-cb43-4619-a78d-aa1a99771ef5
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
KIT
Labeler
Meijer Distribution Inc
Application
ANDA075329
Marketing category
ANDA
Marketing start
2000-02-04
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
Rxcui992765, 992766, 998483, 998540

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
41250-081-00miconazole 31 in 1 CARTONKIT17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]2
MICONAZOLEACTIVE MOIETY7NNO0D7S5MMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]2
COTTONSEED OILINACTIVE INGREDIENTH3E878020NMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]2
WATERINACTIVE INGREDIENT059QF0KO0RMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-081MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [MEIJER DISTRIBUTION INC]6Current NDC, Legacy NDC, 1 package rows20211106_feaa0d07-013e-433f-8db4-550dc9ff737e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992766{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (miconazole nitrate 200 MG Vaginal Insert) } PackGPCKfeaa0d07-013e-433f-8db4-550dc9ff737e7
998483miconazole nitrate 2 % Topical CreamPSNfeaa0d07-013e-433f-8db4-550dc9ff737e7
998540miconazole nitrate 2 % Vaginal CreamPSNfeaa0d07-013e-433f-8db4-550dc9ff737e7
992765miconazole nitrate 200 MG Vaginal InsertPSNfeaa0d07-013e-433f-8db4-550dc9ff737e7
992766miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) PackPSNfeaa0d07-013e-433f-8db4-550dc9ff737e7
998483miconazole nitrate 20 MG/ML Topical CreamSCDfeaa0d07-013e-433f-8db4-550dc9ff737e7
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDfeaa0d07-013e-433f-8db4-550dc9ff737e7
992765miconazole nitrate 200 MG Vaginal InsertSCDfeaa0d07-013e-433f-8db4-550dc9ff737e7
992766miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)SYfeaa0d07-013e-433f-8db4-550dc9ff737e7
992766miconazole 3 Day Vaginal Insert Combination PackSYfeaa0d07-013e-433f-8db4-550dc9ff737e7
998483miconazole nitrate 2 % Topical CreamSYfeaa0d07-013e-433f-8db4-550dc9ff737e7
998540miconazole nitrate 2 % Vaginal CreamSYfeaa0d07-013e-433f-8db4-550dc9ff737e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-081-00412500081001 KIT in 1 CARTON (41250-081-00) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE1 kit2000-02-040000-00-00NoNoCurrent