Miconazole 7

Product NDC
49035-347
11-digit product format
490350347
Labeler code
49035
Product ID
49035-347_f69514e9-6424-4254-9aca-4dcfb1ba3eff
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Application
ANDA074164
Marketing category
ANDA
Marketing start
2020-05-01
Substance
MICONAZOLE NITRATE
Active strength
100 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 7
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE100 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-347-07Miconazole 745 g in 1 TUBE, WITH APPLICATORCREAM455
49035-347-07Miconazole 77 in 1 CARTONCREAM75

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-347-07GM - Gram49035-34763c07312-0484-40b0-813b-ac3e35cf74b412024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-347MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)]5Current NDC, Legacy NDC, 2 package rows20240912_0cef9212-201d-4fd2-8afb-ae06ea6b6ee4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998540miconazole nitrate 2 % Vaginal CreamPSN0cef9212-201d-4fd2-8afb-ae06ea6b6ee45
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD0cef9212-201d-4fd2-8afb-ae06ea6b6ee45
998540miconazole nitrate 2 % Vaginal CreamSY0cef9212-201d-4fd2-8afb-ae06ea6b6ee45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49035-347-07490350347077 TUBE, WITH APPLICATOR in 1 CARTON (49035-347-07) / 45 g in 1 TUBE, WITH APPLICATOR2020-05-010000-00-00NoNoCurrent