FDA.reportPublic FDA data

Clotrimazole

Product NDC
61269-220
11-digit product format
612690220
Labeler code
61269
Product ID
61269-220_1e5b4178-017f-429d-b0d9-bc11863cd67e
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
VAGINAL
Labeler
H2-Pharma, LLC
Application
ANDA074165
Marketing category
ANDA
Marketing start
2021-06-29
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65
Rxcui309368

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61269-220-41Clotrimazole1 in 1 CARTONCREAM12
61269-220-41Clotrimazole45 g in 1 TUBE, WITH APPLICATORCREAM452
61269-220-63Clotrimazole1 in 1 CARTONCREAM12
61269-220-63Clotrimazole45 g in 1 TUBE, WITH APPLICATORCREAM452

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61269-220-41GM - Gram61269-2200830b94c-a7bf-4be1-b0d0-c463f1cc444612021-07-15
61269-220-63GM - Gram61269-220fb2d6f46-aa3c-4840-9e8c-75f28d27d9ac12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61269-220CLOTRIMAZOLE CREAM [H2-PHARMA, LLC]2Current NDC, Legacy NDC, 4 package rows20230112_388f7e35-efbe-496b-a8d6-518caa22328d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309368clotrimazole 1 % Vaginal CreamPSN80d67df3-843d-47bb-85a2-d2f26a8243364
309368clotrimazole 1 % Vaginal CreamPSNfd010006-f646-46ed-841a-9f247b19e3974
309368clotrimazole 10 MG/ML Vaginal CreamSCD80d67df3-843d-47bb-85a2-d2f26a8243364
309368clotrimazole 10 MG/ML Vaginal CreamSCDfd010006-f646-46ed-841a-9f247b19e3974
309368clotrimazole 1 % Vaginal CreamSY80d67df3-843d-47bb-85a2-d2f26a8243364
309368clotrimazole 1 % Vaginal CreamSYfd010006-f646-46ed-841a-9f247b19e3974
309368clotrimazole 1 % Vaginal CreamPSN388f7e35-efbe-496b-a8d6-518caa22328d2
309368clotrimazole 10 MG/ML Vaginal CreamSCD388f7e35-efbe-496b-a8d6-518caa22328d2
309368clotrimazole 1 % Vaginal CreamSY388f7e35-efbe-496b-a8d6-518caa22328d2
309368clotrimazole 1 % Vaginal CreamPSN6b908538-d9ff-41d0-909c-01e1d1b21a391
309368clotrimazole 1 % Vaginal CreamPSNd505c338-ddbe-26eb-e053-2a95a90a02611
309368clotrimazole 10 MG/ML Vaginal CreamSCD6b908538-d9ff-41d0-909c-01e1d1b21a391
309368clotrimazole 10 MG/ML Vaginal CreamSCDd505c338-ddbe-26eb-e053-2a95a90a02611
309368clotrimazole 1 % Vaginal CreamSY6b908538-d9ff-41d0-909c-01e1d1b21a391
309368clotrimazole 1 % Vaginal CreamSYd505c338-ddbe-26eb-e053-2a95a90a02611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61269-220-41612690220411 TUBE, WITH APPLICATOR in 1 CARTON (61269-220-41) / 45 g in 1 TUBE, WITH APPLICATOR2021-06-290000-00-00NoNoCurrent
61269-220-63612690220631 TUBE, WITH APPLICATOR in 1 CARTON (61269-220-63) / 45 g in 1 TUBE, WITH APPLICATOR2021-06-290000-00-00NoNoCurrent