HERS Miconazole 3

Product NDC
71730-070
11-digit product format
717300070
Labeler code
71730
Product ID
71730-070_b2c480f5-6156-4aba-b6aa-7e74dd6b783a
Type
HUMAN OTC DRUG
Nonproprietary name
miconazole nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
Hims Inc
Application
ANDA091366
Marketing category
ANDA
Marketing start
2019-01-14
Substance
MICONAZOLE NITRATE
Active strength
40 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
HERS Miconazole 3
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE40 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998544, 2288429

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
71730-070-14HERS Miconazole 35 g in 1 APPLICATORCREAM53
71730-070-14HERS Miconazole 33 in 1 CARTONCREAM33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71730-070HERS MICONAZOLE 3 (MICONAZOLE NITRATE) CREAM [HIMS INC]3Current NDC, Legacy NDC, 2 package rows20210307_1b2a36fb-48dd-451e-a804-c864be4e5326.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2288429{3 (5000 MG) (miconazole nitrate 40 MG/ML Vaginal Cream) } PackGPCK1b2a36fb-48dd-451e-a804-c864be4e53263
2288429miconazole 4 % Vaginal Cream 3-Day Applicator PackPSN1b2a36fb-48dd-451e-a804-c864be4e53263
998544miconazole nitrate 4 % Vaginal CreamPSN1b2a36fb-48dd-451e-a804-c864be4e53263
998544miconazole nitrate 40 MG/ML Vaginal CreamSCD1b2a36fb-48dd-451e-a804-c864be4e53263
2288429miconazole 4 % 3-Day Prefilled Applicator PackSY1b2a36fb-48dd-451e-a804-c864be4e53263
998544miconazole nitrate 4 % Vaginal CreamSY1b2a36fb-48dd-451e-a804-c864be4e53263

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71730-070-14717300070143 APPLICATOR in 1 CARTON (71730-070-14) / 5 g in 1 APPLICATOR3 applicator2019-01-140000-00-00NoNoCurrent