FDA.reportPublic FDA data

MONISTAT 3

Product NDC
63736-017
11-digit product format
637360017
Labeler code
63736
Product ID
63736-017_dd4127f7-4f74-41fa-b170-d28fe5639cf5
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
KIT
Labeler
Insight Pharmaceuticals LLC
Application
NDA020670
Marketing category
NDA
Marketing start
1996-04-16
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui992765, 992766, 992770, 992771, 998540, 998541

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
63736-017-03MONISTAT 31 in 1 PACKAGE, COMBINATIONKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-017MONISTAT 3 (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 1 package rows20240322_674f2e66-e7e3-40ff-aa21-adaf5d55dcda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992771{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]) / 3 (miconazole nitrate 200 MG Vaginal Insert [Monistat]) } Pack [Monistat 3 Day Ovule Combination Pack]BPCK674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
992766{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (miconazole nitrate 200 MG Vaginal Insert) } PackGPCK674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
998540miconazole nitrate 2 % Vaginal CreamPSN674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
992765miconazole nitrate 200 MG Vaginal InsertPSN674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
992766miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) PackPSN674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
998541Monistat 2 % Vaginal CreamPSN674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
992770Monistat 3 200 MG Vaginal InsertPSN674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
992771Monistat 3 Day Ovule Combination PackPSN674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
998541miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]SBD674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
992770miconazole nitrate 200 MG Vaginal Insert [Monistat]SBD674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
992765miconazole nitrate 200 MG Vaginal InsertSCD674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
992771{1 (0.32 OZ) (miconazole nitrate 2 % Vaginal Cream [Monistat]) / 3 (miconazole nitrate 200 MG Vaginal Insert [Monistat]) } Pack [Monistat 3 Day Ovule Combination Pack]SY674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
992766miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)SY674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
992766miconazole 3 Day Vaginal Insert Combination PackSY674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
998540miconazole nitrate 2 % Vaginal CreamSY674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
998541Monistat 20 MG/ML Vaginal CreamSY674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
992770Monistat 200 MG Vaginal InsertSY674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
992771Monistat 3 Day Ovule Combination PackSY674f2e66-e7e3-40ff-aa21-adaf5d55dcda3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63736-017-03637360017031 KIT in 1 PACKAGE, COMBINATION (63736-017-03) * 3 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE1 kit1996-04-160000-00-00NoNoCurrent