FDA.reportPublic FDA data

Monistat 3 Combination Pack

Product NDC
57501-006
11-digit product format
575010006
Labeler code
57501
Product ID
57501-006_bde53bec-6b4a-4fdd-9499-9306b04ce4d2
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
KIT
Labeler
Apex International Mfg., Inc.
Application
NDA020670
Marketing category
NDA
Marketing start
2020-06-11
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
57501-006-012022-01-28C16284748780-1d6a99b39-425b-a426-e053-dadaa90af4c2MONISTAT 3 Combination Pack - prefilled app and cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57501-006-01Monistat 3 Combination Pack1 in 1 PACKAGE, COMBINATIONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57501-006MONISTAT 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [APEX INTERNATIONAL MFG., INC.]2Legacy NDC, 1 package rows20200714_02c497e9-3b72-4dd2-83eb-a62b2eba1a9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992771{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]) / 3 (miconazole nitrate 200 MG Vaginal Insert [Monistat]) } Pack [Monistat 3 Day Ovule Combination Pack]BPCK02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
992766{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (miconazole nitrate 200 MG Vaginal Insert) } PackGPCK02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
998540miconazole nitrate 2 % Vaginal CreamPSN02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
992765miconazole nitrate 200 MG Vaginal InsertPSN02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
992766miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) PackPSN02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
998544miconazole nitrate 4 % Vaginal CreamPSN02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
998541Monistat 2 % Vaginal CreamPSN02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
992770Monistat 3 200 MG Vaginal InsertPSN02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
998546MONISTAT 3 4 % Vaginal CreamPSN02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
992771Monistat 3 Day Ovule Combination PackPSN02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
998541miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]SBD02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
992770miconazole nitrate 200 MG Vaginal Insert [Monistat]SBD02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
998546miconazole nitrate 40 MG/ML Vaginal Cream [Monistat]SBD02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
992765miconazole nitrate 200 MG Vaginal InsertSCD02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
998544miconazole nitrate 40 MG/ML Vaginal CreamSCD02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
992771{1 (0.32 OZ) (miconazole nitrate 2 % Vaginal Cream [Monistat]) / 3 (miconazole nitrate 200 MG Vaginal Insert [Monistat]) } Pack [Monistat 3 Day Ovule Combination Pack]SY02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
992766miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)SY02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
992766miconazole 3 Day Vaginal Insert Combination PackSY02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
998540miconazole nitrate 2 % Vaginal CreamSY02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
998544miconazole nitrate 4 % Vaginal CreamSY02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
998541Monistat 20 MG/ML Vaginal CreamSY02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
992770Monistat 200 MG Vaginal InsertSY02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
992771Monistat 3 Day Ovule Combination PackSY02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
998546Monistat 4 % Vaginal CreamSY02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2
998546Monistat 40 MG/ML Vaginal CreamSY02c497e9-3b72-4dd2-83eb-a62b2eba1a9f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57501-006-01575010006011 KIT in 1 PACKAGE, COMBINATION (57501-006-01) * 5 g in 1 APPLICATOR * 9 g in 1 TUBE1 kit2020-06-110000-00-00NoNoCurrent