CLOTRIMAZOLE

Product NDC
82568-0036
11-digit product format
825680036
Labeler code
82568
Product ID
82568-0036_4bd825f4-f5e3-aab7-e063-6394a90ad6a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOTRIMAZOLE
Dosage form
SPRAY
Route
TOPICAL
Labeler
AARNA USA INC
Application
ANDA216569
Marketing category
ANDA
Marketing start
2023-10-16
Substance
CLOTRIMAZOLE
Active strength
10 mg/mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CLOTRIMAZOLE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65
Rxcui358371

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
82568-0036-1CLOTRIMAZOLE10 mL in 1 BOTTLESPRAY101
82568-0036-1CLOTRIMAZOLE1 in 1 CARTONSPRAY11
82568-0036-3CLOTRIMAZOLE30 mL in 1 BOTTLESPRAY301
82568-0036-3CLOTRIMAZOLE1 in 1 CARTONSPRAY11
82568-0036-6CLOTRIMAZOLE2 in 1 CARTONSPRAY21
82568-0036-6CLOTRIMAZOLE30 mL in 1 BOTTLESPRAY301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82568-0036-6ML - Milliliter82568-0036ad6f4143-a749-4041-8d85-45d80620561e12026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
358371clotrimazole 1 % Topical SprayPSN4bd825f4-f5e2-aab7-e063-6394a90ad6a41
358371clotrimazole 10 MG/ML Topical SpraySCD4bd825f4-f5e2-aab7-e063-6394a90ad6a41
358371clotrimazole 1 % Topical SpraySY4bd825f4-f5e2-aab7-e063-6394a90ad6a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82568-0036-1825680036011 BOTTLE in 1 CARTON (82568-0036-1) / 10 mL in 1 BOTTLE1 bottle2023-10-16NoNoHistorical
82568-0036-3825680036031 BOTTLE in 1 CARTON (82568-0036-3) / 30 mL in 1 BOTTLE1 bottle2023-10-16NoNoHistorical
82568-0036-6825680036062 BOTTLE in 1 CARTON (82568-0036-6) / 30 mL in 1 BOTTLE2 bottle2024-03-09NoNoHistorical