FDA.reportPublic FDA data

miconazole 7

Product NDC
37808-825
11-digit product format
378080825
Labeler code
37808
Product ID
37808-825_154b2a8e-966f-4dd9-8ce8-30a5adb3aab5
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
H E B
Application
ANDA074760
Marketing category
ANDA
Marketing start
2006-01-09
Substance
MICONAZOLE NITRATE
Active strength
2 g/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
miconazole 7
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE2 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998540

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
37808-825-26miconazole 71 in 1 CARTONCREAM15
37808-825-26miconazole 745 g in 1 TUBE, WITH APPLICATORCREAM455

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37808-825-29GM - Gram37808-825c860757d-cb8b-4b03-b616-3e242a90b33712022-06-06

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-825MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [H E B]5Current NDC, Legacy NDC, 2 package rows20231114_9741b8c0-716a-4c54-9793-387866faf766.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998540miconazole nitrate 2 % Vaginal CreamPSN9741b8c0-716a-4c54-9793-387866faf7665
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD9741b8c0-716a-4c54-9793-387866faf7665
998540miconazole nitrate 2 % Vaginal CreamSY9741b8c0-716a-4c54-9793-387866faf7665

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37808-825-26378080825261 TUBE, WITH APPLICATOR in 1 CARTON (37808-825-26) / 45 g in 1 TUBE, WITH APPLICATOR2006-01-09NoNoCurrent
37808-825-29378080825291 TUBE, WITH APPLICATOR in 1 CARTON (37808-825-29) > 45 g in 1 TUBE, WITH APPLICATOR2006-01-090000-00-00NoNoCurrent