Miconazole Nitrate

Product NDC
0472-1738
11-digit product format
004721738
Labeler code
0472
Product ID
0472-1738_bb1aad58-4ca7-4be9-8649-0f29e22b81f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
SUPPOSITORY
Route
VAGINAL
Labeler
Actavis Pharma, Inc.
Application
ANDA073508
Marketing category
ANDA
Marketing start
1995-01-18
Substance
MICONAZOLE NITRATE
Active strength
200 mg/1
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 NITRATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui992765

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
0472-1738-03Miconazole Nitrate3 in 1 CARTONSUPPOSITORY310

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-1738-03EA - Each0472-1738aa030346-83b0-418d-9fed-f9c9e2faae1f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KMICONAZOLE NITRATE SUPPOSITORY [ACTAVIS MID ATLANTIC LLC]2
MICONAZOLEACTIVE MOIETY7NNO0D7S5MMICONAZOLE NITRATE SUPPOSITORY [ACTAVIS MID ATLANTIC LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0472-1738MICONAZOLE NITRATE SUPPOSITORY [ACTAVIS PHARMA, INC.]10Current NDC, Legacy NDC, 1 package rows20201022_aa9e250b-f317-42cb-b8d2-e85de56f4ef7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992765miconazole nitrate 200 MG Vaginal InsertPSNaa9e250b-f317-42cb-b8d2-e85de56f4ef710
992765miconazole nitrate 200 MG Vaginal InsertSCDaa9e250b-f317-42cb-b8d2-e85de56f4ef710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0472-1738-03004721738033 SUPPOSITORY in 1 CARTON (0472-1738-03) 3 suppository1995-01-180000-00-00NoNoCurrent