MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit

Product NDC
0713-0593
11-digit product format
007130593
Labeler code
0713
Product ID
0713-0593_2b1109b2-d1c4-6d16-e063-6394a90a5df5
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
KIT
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA074926
Marketing category
ANDA
Marketing start
2025-01-03
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui992765, 992766, 998483, 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0713-0593-77MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit1 in 1 CARTONKIT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0593-77EA - Each0713-059368ee4744-c012-4920-ab23-b3d35d8cde8012025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0593MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT (MICONAZOLE NITRATE) KIT [COSETTE PHARMACEUTICALS, INC.]2Current NDC, 1 package rows20250108_eed88487-a7ba-4853-8519-13f92ed5539f.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) } PackGPCKeed88487-a7ba-4853-8519-13f92ed5539f2
998483miconazole nitrate 2 % Topical CreamPSNeed88487-a7ba-4853-8519-13f92ed5539f2
998540miconazole nitrate 2 % Vaginal CreamPSNeed88487-a7ba-4853-8519-13f92ed5539f2
992765miconazole nitrate 200 MG Vaginal InsertPSNeed88487-a7ba-4853-8519-13f92ed5539f2
992766miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) PackPSNeed88487-a7ba-4853-8519-13f92ed5539f2
998483miconazole nitrate 20 MG/ML Topical CreamSCDeed88487-a7ba-4853-8519-13f92ed5539f2
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDeed88487-a7ba-4853-8519-13f92ed5539f2
992765miconazole nitrate 200 MG Vaginal InsertSCDeed88487-a7ba-4853-8519-13f92ed5539f2
992766miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)SYeed88487-a7ba-4853-8519-13f92ed5539f2
992766miconazole 3 Day Vaginal Insert Combination PackSYeed88487-a7ba-4853-8519-13f92ed5539f2
998483miconazole nitrate 2 % Topical CreamSYeed88487-a7ba-4853-8519-13f92ed5539f2
998540miconazole nitrate 2 % Vaginal CreamSYeed88487-a7ba-4853-8519-13f92ed5539f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0713-0593-77007130593771 KIT in 1 CARTON (0713-0593-77) * 9 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE1 kit2025-01-03NoNoCurrent