FDA.reportPublic FDA data

miconazole 3

Product NDC
37808-242
11-digit product format
378080242
Labeler code
37808
Product ID
37808-242_5a63c87d-9f46-4ddc-b662-a0ec944d7798
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
KIT
Labeler
H E B
Application
ANDA075329
Marketing category
ANDA
Marketing start
2006-03-14
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
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
37808-242-00miconazole 31 in 1 CARTONKIT15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [H E B]1
MICONAZOLEACTIVE MOIETY7NNO0D7S5MMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [H E B]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [H E B]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [H E B]1
COTTONSEED OILINACTIVE INGREDIENTH3E878020NMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [H E B]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [H E B]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [H E B]1
PEG-5 OLEATEINACTIVE INGREDIENT0240V77G50MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [H E B]1
PEGOXOL 7 STEARATEINACTIVE INGREDIENT3EW5AXE5X5MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [H E B]1
WATERINACTIVE INGREDIENT059QF0KO0RMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [H E B]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-242MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [H E B]4Current NDC, Legacy NDC, 1 package rows20210424_f24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa6.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) } PackGPCKf24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa65
998483miconazole nitrate 2 % Topical CreamPSNf24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa65
998540miconazole nitrate 2 % Vaginal CreamPSNf24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa65
992765miconazole nitrate 200 MG Vaginal InsertPSNf24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa65
992766miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) PackPSNf24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa65
998483miconazole nitrate 20 MG/ML Topical CreamSCDf24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa65
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDf24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa65
992765miconazole nitrate 200 MG Vaginal InsertSCDf24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa65
992766miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)SYf24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa65
992766miconazole 3 Day Vaginal Insert Combination PackSYf24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa65
998483miconazole nitrate 2 % Topical CreamSYf24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa65
998540miconazole nitrate 2 % Vaginal CreamSYf24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-242-00378080242001 KIT in 1 CARTON (37808-242-00) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE1 kit2006-03-140000-00-00NoNoCurrent