Clocortolone Pivalate

Product NDC
51672-4166
11-digit product format
516724166
Labeler code
51672
Product ID
51672-4166_0b06ddbb-6100-464f-9266-ace704fe8a40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clocortolone Pivalate
Dosage form
CREAM
Route
TOPICAL
Labeler
Taro Pharmaceuticals U.S.A., inc.
Application
ANDA206370
Marketing category
ANDA
Marketing start
2020-04-21
Substance
CLOCORTOLONE PIVALATE
Active strength
.001 g/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOCORTOLONE PIVALATE.001 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQBL8IZH14X
Rxcui197520

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5b4db253-13f4-a186-daf6-9b4e39d96457Product name220200729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4166-6Clocortolone Pivalate1 in 1 CARTONCREAM12
51672-4166-6Clocortolone Pivalate45 g in 1 TUBECREAM452
51672-4166-8Clocortolone Pivalate90 g in 1 TUBECREAM902
51672-4166-8Clocortolone Pivalate1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4166CLOCORTOLONE PIVALATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2Current NDC, Legacy NDC, 4 package rows20220617_88d9a7cf-31b5-4b85-9827-0ecce328e6a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197520clocortolone (as clocortolone pivalate) 0.1 % Topical CreamPSN88d9a7cf-31b5-4b85-9827-0ecce328e6a02
197520clocortolone 1 MG/ML Topical CreamSCD88d9a7cf-31b5-4b85-9827-0ecce328e6a02
197520clocortolone (as clocortolone pivalate) 0.1 % Topical CreamSY88d9a7cf-31b5-4b85-9827-0ecce328e6a02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4166-6516724166061 TUBE in 1 CARTON (51672-4166-6) / 45 g in 1 TUBE1 tube2020-04-210000-00-00NoNoCurrent
51672-4166-8516724166081 TUBE in 1 CARTON (51672-4166-8) / 90 g in 1 TUBE1 tube2020-04-210000-00-00NoNoCurrent