FDA.reportPublic FDA data

Miconazole Nitrate

Product NDC
51672-2035
11-digit product format
516722035
Labeler code
51672
Product ID
51672-2035_362a2e22-e1bb-aae7-e063-6394a90a33f0
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA074444
Marketing category
ANDA
Marketing start
1997-01-13
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
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 Nitrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51672-2035-62020-02-03C16284748780-19d75b9d0-036a-f424-e053-dadaa90a57ceMiconazole Nitrate
51672-2035-72020-02-03C16284748780-19d75b9d0-036a-f424-e053-dadaa90a57ceMiconazole Nitrate
51672-2035-62020-01-31C16284748780-19d75b9d0-036a-f424-e053-dadaa90a57ceMiconazole Nitrate
51672-2035-72020-01-31C16284748780-19d75b9d0-036a-f424-e053-dadaa90a57ceMiconazole Nitrate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2035-6Miconazole Nitrate45 g in 1 TUBE, WITH APPLICATORCREAM454
51672-2035-6Miconazole Nitrate1 in 1 CARTONCREAM14
51672-2035-7Miconazole Nitrate1 in 1 CARTONCREAM14
51672-2035-7Miconazole Nitrate45 g in 1 TUBE, WITH APPLICATORCREAM454

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2035-6GM - Gram51672-2035ca7f881d-7207-42aa-a3d7-8fd4ebfcb0a412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1KMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
MiconazoleACTIVE MOIETY7NNO0D7S5MMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
Benzoic AcidINACTIVE INGREDIENT8SKN0B0MIMMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
Butylated HydroxytolueneINACTIVE INGREDIENT1P9D0Z171KMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
Mineral OilINACTIVE INGREDIENTT5L8T28FGPMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2035MICONAZOLE NITRATE CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.]4Current NDC, Legacy NDC, 4 package rows20250529_6b34d0be-4bcd-4dff-b732-7fbd46765019.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998540miconazole nitrate 2 % Vaginal CreamPSNa32fc37b-bcad-4f56-8dc6-cf36a67161969
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDa32fc37b-bcad-4f56-8dc6-cf36a67161969
998540miconazole nitrate 2 % Vaginal CreamSYa32fc37b-bcad-4f56-8dc6-cf36a67161969
998540miconazole nitrate 2 % Vaginal CreamPSN6b34d0be-4bcd-4dff-b732-7fbd467650194
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD6b34d0be-4bcd-4dff-b732-7fbd467650194
998540miconazole nitrate 2 % Vaginal CreamSY6b34d0be-4bcd-4dff-b732-7fbd467650194
998540miconazole nitrate 2 % Vaginal CreamPSNf562b57d-65a8-93fa-e053-2995a90ae3e01
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDf562b57d-65a8-93fa-e053-2995a90ae3e01
998540miconazole nitrate 2 % Vaginal CreamSYf562b57d-65a8-93fa-e053-2995a90ae3e01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51672-2035-6516722035061 TUBE, WITH APPLICATOR in 1 CARTON (51672-2035-6) / 45 g in 1 TUBE, WITH APPLICATOR1997-01-130000-00-00NoNoCurrent
51672-2035-7516722035071 TUBE, WITH APPLICATOR in 1 CARTON (51672-2035-7) / 45 g in 1 TUBE, WITH APPLICATOR1997-01-130000-00-00NoNoCurrent