FDA.reportPublic FDA data

Vagistat-3

Product NDC
76413-352
11-digit product format
764130352
Labeler code
76413
Product ID
76413-352_939ce2ff-51df-4785-a7aa-5291916e59e6
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
KIT
Labeler
Central Texas Community Health Centers
Application
ANDA075329
Marketing category
ANDA
Marketing start
2000-02-25
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
76413-352-032020-01-31C16284748780-19d75b9d0-e764-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76413-352-03Vagistat-31 in 1 CARTONKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76413-352VAGISTAT-3 (MICONAZOLE NITRATE) KIT [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]3Legacy NDC, 1 package rows20181010_b5998ee2-d22b-4f3f-adf6-99482b1f7946.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992792{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream [Vagistat]) / 3 (miconazole nitrate 200 MG Vaginal Insert [Vagistat]) } Pack [Vagistat 3 Day Combination Pack]BPCKb5998ee2-d22b-4f3f-adf6-99482b1f79463
992766{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (miconazole nitrate 200 MG Vaginal Insert) } PackGPCKb5998ee2-d22b-4f3f-adf6-99482b1f79463
998540miconazole nitrate 2 % Vaginal CreamPSNb5998ee2-d22b-4f3f-adf6-99482b1f79463
992765miconazole nitrate 200 MG Vaginal InsertPSNb5998ee2-d22b-4f3f-adf6-99482b1f79463
992766miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) PackPSNb5998ee2-d22b-4f3f-adf6-99482b1f79463
1359442Vagistat 2 % Vaginal CreamPSNb5998ee2-d22b-4f3f-adf6-99482b1f79463
992792Vagistat 3 Combination PackPSNb5998ee2-d22b-4f3f-adf6-99482b1f79463
992791Vagistat-3 200 MG Vaginal InsertPSNb5998ee2-d22b-4f3f-adf6-99482b1f79463
1359442miconazole nitrate 20 MG/ML Vaginal Cream [Vagistat]SBDb5998ee2-d22b-4f3f-adf6-99482b1f79463
992791miconazole nitrate 200 MG Vaginal Insert [Vagistat]SBDb5998ee2-d22b-4f3f-adf6-99482b1f79463
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDb5998ee2-d22b-4f3f-adf6-99482b1f79463
992765miconazole nitrate 200 MG Vaginal InsertSCDb5998ee2-d22b-4f3f-adf6-99482b1f79463
992766miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)SYb5998ee2-d22b-4f3f-adf6-99482b1f79463
992766miconazole 3 Day Vaginal Insert Combination PackSYb5998ee2-d22b-4f3f-adf6-99482b1f79463
998540miconazole nitrate 2 % Vaginal CreamSYb5998ee2-d22b-4f3f-adf6-99482b1f79463
1359442Vagistat 2 % Vaginal CreamSYb5998ee2-d22b-4f3f-adf6-99482b1f79463
992791Vagistat 200 MG Vaginal InsertSYb5998ee2-d22b-4f3f-adf6-99482b1f79463
992792Vagistat 3 Combination PackSYb5998ee2-d22b-4f3f-adf6-99482b1f79463
1359442Vagistat-3 2 % Vaginal CreamSYb5998ee2-d22b-4f3f-adf6-99482b1f79463
992791Vagistat-3 200 MG Vaginal InsertSYb5998ee2-d22b-4f3f-adf6-99482b1f79463

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76413-352-03764130352031 in 1 CARTONHistorical