Baza Antifungal

Product NDC
11701-045
11-digit product format
117010045
Labeler code
11701
Product ID
11701-045_1b6f34e8-44ed-435a-9741-fc4d859b541f
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Coloplast Corp
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-06-15
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Baza Antifungal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998483, 998493

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11701-045-14Baza Antifungal142 g in 1 TUBECREAM14210
11701-045-22Baza Antifungal4 g in 1 PACKETCREAM410
11701-045-23Baza Antifungal57 g in 1 TUBECREAM5710

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11701-045-14GM - Gram11701-045387f5d9c-bbfa-4572-ada8-b8a1a27de39e12012-07-24
11701-045-22GM - Gram11701-04587ac6440-1bb9-4939-a96d-a0ca5057468312012-07-24
11701-045-23GM - Gram11701-045d3131d7f-0c66-4363-b855-b69f1a2f6caa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KBAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
MICONAZOLEACTIVE MOIETY7NNO0D7S5MBAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4NBAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KBAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
CETEARETH-6INACTIVE INGREDIENT2RJS3559D3BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNBAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
COD LIVER OILINACTIVE INGREDIENTBBL281NWFGBAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
LANOLININACTIVE INGREDIENT7EV65EAW6HBAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RBAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YBAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RBAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZBAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11701-045BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]7Current NDC, Legacy NDC, 3 package rows20241228_75182cb7-840a-423a-9c20-10840d6e1d65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998493Baza Antifungal 2 % Topical CreamPSN75182cb7-840a-423a-9c20-10840d6e1d6510
998483miconazole nitrate 2 % Topical CreamPSN75182cb7-840a-423a-9c20-10840d6e1d6510
998493miconazole nitrate 20 MG/ML Topical Cream [Baza]SBD75182cb7-840a-423a-9c20-10840d6e1d6510
998483miconazole nitrate 20 MG/ML Topical CreamSCD75182cb7-840a-423a-9c20-10840d6e1d6510
998493BAZA 20 MG/ML Topical CreamSY75182cb7-840a-423a-9c20-10840d6e1d6510
998493Baza Antifungal 2 % Topical CreamSY75182cb7-840a-423a-9c20-10840d6e1d6510
998483miconazole nitrate 2 % Topical CreamSY75182cb7-840a-423a-9c20-10840d6e1d6510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11701-045-1411701004514142 g in 1 TUBE (11701-045-14) 142 g2009-06-150000-00-00NoNoCurrent
11701-045-22117010045224 g in 1 PACKET (11701-045-22) 4 g2009-06-150000-00-00NoNoCurrent
11701-045-231170100452357 g in 1 TUBE (11701-045-23) 57 g2009-06-150000-00-00NoNoCurrent