Miconazole 3

Product NDC
0363-5203
11-digit product format
003635203
Labeler code
0363
Product ID
0363-5203_d536a071-d970-4dca-86d0-669dcc421ae6
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
KIT
Route
VAGINAL
Labeler
WALGREEN COMPANY
Application
NDA020670
Marketing category
NDA
Marketing start
2016-04-18
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Miconazole 3
Brand name suffix
Walgreen Company
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-5203-012026-01-20C16284748780-1f386c649-b8f1-0266-e053-dadaa90a7c1aMiconazole 3 Combination Pack
0363-5203-012023-01-30C16284748780-1f386c649-b8f1-0266-e053-dadaa90a7c1aMiconazole 3 Combination Pack

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-5203-01Miconazole 3Walgreen Company1 in 1 PACKAGE, COMBINATIONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-5203MICONAZOLE 3 WALGREEN COMPANY (MICONAZOLE NITRATE) KIT [WALGREEN COMPANY]1Current NDC, Legacy NDC, 1 package rows20211110_32b373be-9c8e-49b0-a796-8d87f6a20cef.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) } PackGPCK32b373be-9c8e-49b0-a796-8d87f6a20cef2
998540miconazole nitrate 2 % Vaginal CreamPSN32b373be-9c8e-49b0-a796-8d87f6a20cef2
992765miconazole nitrate 200 MG Vaginal InsertPSN32b373be-9c8e-49b0-a796-8d87f6a20cef2
992766miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) PackPSN32b373be-9c8e-49b0-a796-8d87f6a20cef2
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD32b373be-9c8e-49b0-a796-8d87f6a20cef2
992765miconazole nitrate 200 MG Vaginal InsertSCD32b373be-9c8e-49b0-a796-8d87f6a20cef2
992766miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)SY32b373be-9c8e-49b0-a796-8d87f6a20cef2
992766miconazole 3 Day Vaginal Insert Combination PackSY32b373be-9c8e-49b0-a796-8d87f6a20cef2
998540miconazole nitrate 2 % Vaginal CreamSY32b373be-9c8e-49b0-a796-8d87f6a20cef2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-5203-01003635203011 KIT in 1 PACKAGE, COMBINATION (0363-5203-01) * 1 APPLICATOR in 1 PACKAGE / 1 SUPPOSITORY in 1 APPLICATOR * 9 g in 1 TUBE1 kit2016-04-180000-00-00NoNoCurrent