Clotrimazole

Product NDC
70677-1262
11-digit product format
706771262
Labeler code
70677
Product ID
70677-1262_3a767c0f-29db-c885-e063-6394a90aae7a
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
VAGINAL
Labeler
STRATEGIC SOURCING SERVICES LLC
Application
ANDA072641
Marketing category
ANDA
Marketing start
2024-11-07
Substance
CLOTRIMAZOLE
Active strength
1 g/100g
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
CLOTRIMAZOLE1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65
Rxcui309368

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1262-1Clotrimazole45 g in 1 TUBECREAM453
70677-1262-1Clotrimazole1 in 1 CARTONCREAM13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1262-1GM - Gram70677-12624223c97b-743a-4b2c-ba87-e1f879427a2612025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1262CLOTRIMAZOLE CREAM [STRATEGIC SOURCING SERVICES LLC]2Current NDC, 2 package rows20241116_8c7cc657-28a1-4720-97ce-098207bfc470.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309368clotrimazole 1 % Vaginal CreamPSN8c7cc657-28a1-4720-97ce-098207bfc4703
309368clotrimazole 10 MG/ML Vaginal CreamSCD8c7cc657-28a1-4720-97ce-098207bfc4703
309368clotrimazole 1 % Vaginal CreamSY8c7cc657-28a1-4720-97ce-098207bfc4703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1262-1706771262011 TUBE in 1 CARTON (70677-1262-1) / 45 g in 1 TUBE1 tube2024-11-07NoNoHistorical