FDA.reportPublic FDA data

VAGISTAT 3

Product NDC
11509-0081
11-digit product format
115090081
Labeler code
11509
Product ID
11509-0081_9181ac4a-a921-4c23-a199-eb62910b33f5
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
KIT
Labeler
Combe Incorporated
Application
ANDA075329
Marketing category
ANDA
Marketing start
2018-03-27
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VAGISTAT 3
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui992765, 992766, 992791, 992792, 998540, 1359442

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
11509-0081-1VAGISTAT 31 in 1 CARTONKIT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11509-0081-1EA - Each11509-00815a7d0ca1-e852-4798-a695-a980af9e4ae312019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11509-0081VAGISTAT 3 (MICONAZOLE NITRATE) KIT [COMBE INCORPORATED]5Current NDC, Legacy NDC, 1 package rows20250507_e15a28cd-9e64-4e9e-8df9-829d84f1816c.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]BPCKe15a28cd-9e64-4e9e-8df9-829d84f1816c6
992766{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (miconazole nitrate 200 MG Vaginal Insert) } PackGPCKe15a28cd-9e64-4e9e-8df9-829d84f1816c6
998540miconazole nitrate 2 % Vaginal CreamPSNe15a28cd-9e64-4e9e-8df9-829d84f1816c6
992765miconazole nitrate 200 MG Vaginal InsertPSNe15a28cd-9e64-4e9e-8df9-829d84f1816c6
992766miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) PackPSNe15a28cd-9e64-4e9e-8df9-829d84f1816c6
1359442Vagistat 2 % Vaginal CreamPSNe15a28cd-9e64-4e9e-8df9-829d84f1816c6
992792Vagistat 3 Combination PackPSNe15a28cd-9e64-4e9e-8df9-829d84f1816c6
992791Vagistat-3 200 MG Vaginal InsertPSNe15a28cd-9e64-4e9e-8df9-829d84f1816c6
1359442miconazole nitrate 20 MG/ML Vaginal Cream [Vagistat]SBDe15a28cd-9e64-4e9e-8df9-829d84f1816c6
992791miconazole nitrate 200 MG Vaginal Insert [Vagistat]SBDe15a28cd-9e64-4e9e-8df9-829d84f1816c6
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDe15a28cd-9e64-4e9e-8df9-829d84f1816c6
992765miconazole nitrate 200 MG Vaginal InsertSCDe15a28cd-9e64-4e9e-8df9-829d84f1816c6
992766miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)SYe15a28cd-9e64-4e9e-8df9-829d84f1816c6
992766miconazole 3 Day Vaginal Insert Combination PackSYe15a28cd-9e64-4e9e-8df9-829d84f1816c6
998540miconazole nitrate 2 % Vaginal CreamSYe15a28cd-9e64-4e9e-8df9-829d84f1816c6
1359442Vagistat 2 % Vaginal CreamSYe15a28cd-9e64-4e9e-8df9-829d84f1816c6
992791Vagistat 200 MG Vaginal InsertSYe15a28cd-9e64-4e9e-8df9-829d84f1816c6
992792Vagistat 3 Combination PackSYe15a28cd-9e64-4e9e-8df9-829d84f1816c6
1359442Vagistat-3 2 % Vaginal CreamSYe15a28cd-9e64-4e9e-8df9-829d84f1816c6
992791Vagistat-3 200 MG Vaginal InsertSYe15a28cd-9e64-4e9e-8df9-829d84f1816c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11509-0081-1115090081011 KIT in 1 CARTON (11509-0081-1) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE1 kit2018-03-270000-00-00NoNoCurrent