Miconazole 3 Combination Pack

Product NDC
59726-989
11-digit product format
597260989
Labeler code
59726
Product ID
59726-989_6f8b9402-06d9-4860-8d2a-aaa6fab730a8
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
KIT
Labeler
P & L Development, LLC
Application
ANDA074926
Marketing category
ANDA
Marketing start
2021-06-25
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
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui992765, 992766, 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59726-989-032023-04-20C16284748780-1f386c64a-1fa7-0266-e053-dadaa90a7c1aMiconazole 3 Combination Pack
59726-989-032023-01-30C16284748780-1f386c64a-1fa7-0266-e053-dadaa90a7c1aMiconazole 3 Combination Pack

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59726-989-03Miconazole 3 Combination Pack1 in 1 PACKAGE, COMBINATIONKIT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-989MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [P & L DEVELOPMENT, LLC]5Current NDC, Legacy NDC, 1 package rows20241106_a61ee45f-d2e0-4ac1-871d-fa1b3096e89b.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) } PackGPCKa61ee45f-d2e0-4ac1-871d-fa1b3096e89b5
998540miconazole nitrate 2 % Vaginal CreamPSNa61ee45f-d2e0-4ac1-871d-fa1b3096e89b5
992765miconazole nitrate 200 MG Vaginal InsertPSNa61ee45f-d2e0-4ac1-871d-fa1b3096e89b5
992766miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) PackPSNa61ee45f-d2e0-4ac1-871d-fa1b3096e89b5
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDa61ee45f-d2e0-4ac1-871d-fa1b3096e89b5
992765miconazole nitrate 200 MG Vaginal InsertSCDa61ee45f-d2e0-4ac1-871d-fa1b3096e89b5
992766miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)SYa61ee45f-d2e0-4ac1-871d-fa1b3096e89b5
992766miconazole 3 Day Vaginal Insert Combination PackSYa61ee45f-d2e0-4ac1-871d-fa1b3096e89b5
998540miconazole nitrate 2 % Vaginal CreamSYa61ee45f-d2e0-4ac1-871d-fa1b3096e89b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59726-989-03597260989031 KIT in 1 PACKAGE, COMBINATION (59726-989-03) * 9 g in 1 TUBE * 3 SUPPOSITORY in 1 BLISTER PACK1 kit2021-06-250000-00-00NoNoCurrent