FDA.reportPublic FDA data

Alclometasone Dipropionate

Product NDC
68462-299
11-digit product format
684620299
Labeler code
68462
Product ID
68462-299_098145f1-cb92-4222-8069-72fbf92fce9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alclometasone Dipropionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA079227
Marketing category
ANDA
Marketing start
2009-07-30
Substance
ALCLOMETASONE DIPROPIONATE
Active strength
.5 mg/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
Alclometasone Dipropionate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCLOMETASONE DIPROPIONATE.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS56PQL4N1V
Rxcui855474, 855480

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
f918e05b-8992-05ee-78d7-3c419fb21558Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-299-17Alclometasone Dipropionate15 g in 1 TUBEOINTMENT1515
68462-299-47Alclometasone Dipropionate45 g in 1 TUBEOINTMENT4515
68462-299-65Alclometasone Dipropionate60 g in 1 TUBEOINTMENT6015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-299-17GM - Gram68462-2992a908872-dd99-442a-8eb9-1fde1c9c63fc12013-07-02
68462-299-47GM - Gram68462-2995b5d6890-0798-4bd4-8547-bab3115e07b712013-07-02
68462-299-65GM - Gram68462-2999f8bcb27-e928-4461-a035-fed1aee16c3812013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCLOMETASONE DIPROPIONATEACTIVE INGREDIENTS56PQL4N1VALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]8
ALCLOMETASONEACTIVE MOIETY136H45TB7BALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]8
CETETH-20INACTIVE INGREDIENTI835H2IHHXALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]8
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]8
CHLOROCRESOLINACTIVE INGREDIENT36W53O7109ALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]8
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4ALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]8
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]8
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]8
PEG-25 PROPYLENE GLYCOL STEARATEINACTIVE INGREDIENTX21KPH4633ALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]8
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]8
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]8
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]8
WATERINACTIVE INGREDIENT059QF0KO0RALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]8
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-299ALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]15Current NDC, Legacy NDC, 3 package rows20240118_63e635e0-65d8-4b30-9f2a-ab16deba90bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855474alclometasone dipropionate 0.05 % Topical CreamPSN63e635e0-65d8-4b30-9f2a-ab16deba90bd15
855480alclometasone dipropionate 0.05 % Topical OintmentPSN63e635e0-65d8-4b30-9f2a-ab16deba90bd15
855480alclometasone dipropionate 0.0005 MG/MG Topical OintmentSCD63e635e0-65d8-4b30-9f2a-ab16deba90bd15
855474alclometasone dipropionate 0.5 MG/ML Topical CreamSCD63e635e0-65d8-4b30-9f2a-ab16deba90bd15
855474alclometasone dipropionate 0.05 % Topical CreamSY63e635e0-65d8-4b30-9f2a-ab16deba90bd15
855480alclometasone dipropionate 0.05 % Topical OintmentSY63e635e0-65d8-4b30-9f2a-ab16deba90bd15
855480alclometasone dipropionate 0.5 MG/GM Topical OintmentSY63e635e0-65d8-4b30-9f2a-ab16deba90bd15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-299-176846202991715 g in 1 TUBE (68462-299-17) 15 g2009-07-300000-00-00NoNoCurrent
68462-299-476846202994745 g in 1 TUBE (68462-299-47) 45 g2009-07-300000-00-00NoNoCurrent
68462-299-656846202996560 g in 1 TUBE (68462-299-65) 60 g2009-07-300000-00-00NoNoCurrent