FDA.reportPublic FDA data

Miconazole 3 Combination Pack

Product NDC
68016-731
11-digit product format
680160731
Labeler code
68016
Product ID
68016-731_0c7a9e1a-ac2f-4faa-afbf-b2d19287b897
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
KIT
Labeler
Chain Drug Consortium, LLC
Application
ANDA074926
Marketing category
ANDA
Marketing start
2003-09-11
Marketing end
2026-12-31
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Miconazole 3 Combination Pack

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui992765, 992766, 998540

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
68016-731-04Miconazole 3 Combination Pack1 in 1 PACKAGE, COMBINATIONKIT115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-731-04EA - Each68016-73137e52d7f-d9d3-425f-aa74-7faa7210a75d12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CHAIN DRUG CONSORTIUM, LLC]5
MICONAZOLEACTIVE MOIETY7NNO0D7S5MMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CHAIN DRUG CONSORTIUM, LLC]5
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CHAIN DRUG CONSORTIUM, LLC]5
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CHAIN DRUG CONSORTIUM, LLC]5
HYDROGENATED PALM KERNEL OILINACTIVE INGREDIENTFM8D1RE2VPMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CHAIN DRUG CONSORTIUM, LLC]5
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CHAIN DRUG CONSORTIUM, LLC]5
PEG-5 OLEATEINACTIVE INGREDIENT0240V77G50MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CHAIN DRUG CONSORTIUM, LLC]5
PEGOXOL 7 STEARATEINACTIVE INGREDIENT3EW5AXE5X5MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CHAIN DRUG CONSORTIUM, LLC]5
WATERINACTIVE INGREDIENT059QF0KO0RMICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CHAIN DRUG CONSORTIUM, LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-731MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CHAIN DRUG CONSORTIUM, LLC]13Current NDC, Legacy NDC, 1 package rows20221122_d01f7ef9-4f04-4874-a625-0335f6392b73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992766{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (miconazole nitrate 200 MG Vaginal Insert) } PackGPCKd01f7ef9-4f04-4874-a625-0335f6392b7315
998540miconazole nitrate 2 % Vaginal CreamPSNd01f7ef9-4f04-4874-a625-0335f6392b7315
992765miconazole nitrate 200 MG Vaginal InsertPSNd01f7ef9-4f04-4874-a625-0335f6392b7315
992766miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) PackPSNd01f7ef9-4f04-4874-a625-0335f6392b7315
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDd01f7ef9-4f04-4874-a625-0335f6392b7315
992765miconazole nitrate 200 MG Vaginal InsertSCDd01f7ef9-4f04-4874-a625-0335f6392b7315
992766miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)SYd01f7ef9-4f04-4874-a625-0335f6392b7315
992766miconazole 3 Day Vaginal Insert Combination PackSYd01f7ef9-4f04-4874-a625-0335f6392b7315
998540miconazole nitrate 2 % Vaginal CreamSYd01f7ef9-4f04-4874-a625-0335f6392b7315

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-731-04680160731041 KIT in 1 PACKAGE, COMBINATION (68016-731-04) * 3 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE1 kit2003-09-112026-12-31NoNoCurrent