miconazole 1

Product NDC
37808-199
11-digit product format
378080199
Labeler code
37808
Product ID
37808-199_a4b8e7c8-3d3e-4560-bf58-3acfe1266790
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
KIT
Labeler
H E B
Application
ANDA079114
Marketing category
ANDA
Marketing start
2010-06-07
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
miconazole 1
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui992774, 992775, 998483, 998540

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
37808-199-00miconazole 11 in 1 CARTONKIT16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KMICONAZOLE 1 (MICONAZOLE NITRATE) KIT [H E B]2
MICONAZOLEACTIVE MOIETY7NNO0D7S5MMICONAZOLE 1 (MICONAZOLE NITRATE) KIT [H E B]2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMMICONAZOLE 1 (MICONAZOLE NITRATE) KIT [H E B]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UMICONAZOLE 1 (MICONAZOLE NITRATE) KIT [H E B]2
GELATININACTIVE INGREDIENT2G86QN327LMICONAZOLE 1 (MICONAZOLE NITRATE) KIT [H E B]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMICONAZOLE 1 (MICONAZOLE NITRATE) KIT [H E B]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [H E B]2
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPMICONAZOLE 1 (MICONAZOLE NITRATE) KIT [H E B]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UMICONAZOLE 1 (MICONAZOLE NITRATE) KIT [H E B]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMICONAZOLE 1 (MICONAZOLE NITRATE) KIT [H E B]2
PEG-5 OLEATEINACTIVE INGREDIENT0240V77G50MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [H E B]2
PEGOXOL 7 STEARATEINACTIVE INGREDIENT3EW5AXE5X5MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [H E B]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UMICONAZOLE 1 (MICONAZOLE NITRATE) KIT [H E B]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMICONAZOLE 1 (MICONAZOLE NITRATE) KIT [H E B]2
WATERINACTIVE INGREDIENT059QF0KO0RMICONAZOLE 1 (MICONAZOLE NITRATE) KIT [H E B]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-199MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [H E B]6Current NDC, Legacy NDC, 1 package rows20221115_40cc911b-2c35-4382-a979-fb1a165049db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992775{1 (miconazole nitrate 1200 MG Vaginal Insert) / 1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) } PackGPCK40cc911b-2c35-4382-a979-fb1a165049db6
992775miconazole 1 day - (1200 MG insert / 2 % cream 9 GM) PackPSN40cc911b-2c35-4382-a979-fb1a165049db6
992774miconazole nitrate 1200 MG Vaginal InsertPSN40cc911b-2c35-4382-a979-fb1a165049db6
998483miconazole nitrate 2 % Topical CreamPSN40cc911b-2c35-4382-a979-fb1a165049db6
998540miconazole nitrate 2 % Vaginal CreamPSN40cc911b-2c35-4382-a979-fb1a165049db6
992774miconazole nitrate 1200 MG Vaginal InsertSCD40cc911b-2c35-4382-a979-fb1a165049db6
998483miconazole nitrate 20 MG/ML Topical CreamSCD40cc911b-2c35-4382-a979-fb1a165049db6
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD40cc911b-2c35-4382-a979-fb1a165049db6
992774miconazole nitrate 1.2 GM Vaginal InsertSY40cc911b-2c35-4382-a979-fb1a165049db6
998483miconazole nitrate 2 % Topical CreamSY40cc911b-2c35-4382-a979-fb1a165049db6
998540miconazole nitrate 2 % Vaginal CreamSY40cc911b-2c35-4382-a979-fb1a165049db6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-199-00378080199001 KIT in 1 CARTON (37808-199-00) * 1 SUPPOSITORY in 1 POUCH * 9 g in 1 TUBE1 kit2010-06-070000-00-00NoNoCurrent