FDA.reportPublic FDA data

Rugby Miconazole 3

Product NDC
0536-1425
11-digit product format
005361425
Labeler code
0536
Product ID
0536-1425_1ce3070d-0513-43e8-99f9-c582bb707f51
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
KIT
Labeler
Rugby Laboratories
Application
ANDA076357
Marketing category
ANDA
Marketing start
2024-04-23
Marketing end
2027-06-30
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rugby Miconazole 3

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui992816, 998540, 998544

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
0113-7198-00Rugby Miconazole 31 in 1 POUCHCREAM4 g in 100g3
0113-7198-00Rugby Miconazole 35 g in 1 APPLICATORCREAM15 g4 g in 100g3
0113-8123-00Rugby Miconazole 39 g in 1 TUBECREAM9 g2 g in 100g3
0113-8123-00Rugby Miconazole 31 in 1 CARTONCREAM2 g in 100g3
0536-1425-41Rugby Miconazole 31 in 1 CARTONKIT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1425-41GM - Gram0536-14254574ac33-ddef-4442-89b3-fc862943b3d912024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1425RUGBY MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [RUGBY LABORATORIES]1Current NDC, 5 package rows20240711_2d7035fa-9695-4d66-89f5-bd26420450ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992816{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (5000 MG) (miconazole nitrate 40 MG/ML Vaginal Cream) } PackGPCK2d7035fa-9695-4d66-89f5-bd26420450ef3
992816miconazole 3 Day - (4 % applicator 5 GM / 2 % cream 9 GM) PackPSN2d7035fa-9695-4d66-89f5-bd26420450ef3
998540miconazole nitrate 2 % Vaginal CreamPSN2d7035fa-9695-4d66-89f5-bd26420450ef3
998544miconazole nitrate 4 % Vaginal CreamPSN2d7035fa-9695-4d66-89f5-bd26420450ef3
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD2d7035fa-9695-4d66-89f5-bd26420450ef3
998544miconazole nitrate 40 MG/ML Vaginal CreamSCD2d7035fa-9695-4d66-89f5-bd26420450ef3
992816{3 (5 GM miconazole nitrate 200 MG (4 % ) Prefilled Applicator) / 1 (9 GM miconazole nitrate 2 % Vaginal Cream) } PackSY2d7035fa-9695-4d66-89f5-bd26420450ef3
992816{3 (5000 MG miconazole nitrate 4 % Prefilled Applicator) / 1 (0.32 OZ miconazole nitrate 2 % Vaginal Cream) } PackSY2d7035fa-9695-4d66-89f5-bd26420450ef3
992816Miconazole 3 Day Prefilled Applicator Combination PackSY2d7035fa-9695-4d66-89f5-bd26420450ef3
998540miconazole nitrate 2 % Vaginal CreamSY2d7035fa-9695-4d66-89f5-bd26420450ef3
998544miconazole nitrate 4 % Vaginal CreamSY2d7035fa-9695-4d66-89f5-bd26420450ef3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-7198-00001137198001 in 1 POUCHHistorical
0113-8123-00001138123009 g in 1 TUBE9 gHistorical
0536-1425-41005361425411 KIT in 1 CARTON (0536-1425-41) * 1 APPLICATOR in 1 POUCH (0113-7198-00) / 5 g in 1 APPLICATOR * 1 TUBE in 1 CARTON (0113-8123-00) / 9 g in 1 TUBE1 kit2024-04-232027-06-30NoNoHistorical