Miconazole 7

Product NDC
49348-833
11-digit product format
493480833
Labeler code
49348
Product ID
49348-833_274e7b2b-9aaa-4b8e-8cc0-a88ca1cbecde
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
SUPPOSITORY
Route
VAGINAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA073507
Marketing category
ANDA
Marketing start
2011-12-09
Marketing end
2026-12-09
Substance
MICONAZOLE NITRATE
Active strength
100 mg/1
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Miconazole 7

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui992780

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-833-61Miconazole 77 in 1 APPLICATORSUPPOSITORY714

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-833-61EA - Each49348-83391bde22e-afb4-40cf-9552-9e3aeca0a3db12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KMICONAZOLE 7 (MICONAZOLE NITRATE) SUPPOSITORY [MCKESSON]3
MICONAZOLEACTIVE MOIETY7NNO0D7S5MMICONAZOLE 7 (MICONAZOLE NITRATE) SUPPOSITORY [MCKESSON]3
HYDROGENATED PALM KERNEL OILINACTIVE INGREDIENTFM8D1RE2VPMICONAZOLE 7 (MICONAZOLE NITRATE) SUPPOSITORY [MCKESSON]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-833MICONAZOLE 7 (MICONAZOLE NITRATE) SUPPOSITORY [STRATEGIC SOURCING SERVICES LLC]12Current NDC, Legacy NDC, 1 package rows20241122_89132802-beb1-42f4-8da4-39918fc5c4dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992780miconazole nitrate 100 MG Vaginal InsertPSN89132802-beb1-42f4-8da4-39918fc5c4dd14
992780miconazole nitrate 100 MG Vaginal InsertSCD89132802-beb1-42f4-8da4-39918fc5c4dd14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-833-61493480833617 SUPPOSITORY in 1 APPLICATOR (49348-833-61) 7 suppository2011-12-092026-12-09NoNoCurrent