FDA.reportPublic FDA data

Alclometasone Dipropionate

Product NDC
51672-1316
11-digit product format
516721316
Labeler code
51672
Product ID
51672-1316_3c44a51b-8abe-ceae-e063-6294a90a482c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alclometasone dipropionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA076730
Marketing category
ANDA
Marketing start
2004-07-29
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
Rxcui855480

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f918e05b-8992-05ee-78d7-3c419fb21558Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1316-1Alclometasone Dipropionate15 g in 1 TUBEOINTMENT156
51672-1316-1Alclometasone Dipropionate1 in 1 CARTONOINTMENT16
51672-1316-3Alclometasone Dipropionate60 g in 1 TUBEOINTMENT606
51672-1316-3Alclometasone Dipropionate1 in 1 CARTONOINTMENT16
51672-1316-5Alclometasone Dipropionate5 g in 1 TUBEOINTMENT56
51672-1316-6Alclometasone Dipropionate45 g in 1 TUBEOINTMENT456
51672-1316-6Alclometasone Dipropionate1 in 1 CARTONOINTMENT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1316-1GM - Gram51672-1316e1f2381a-616f-4b9d-95db-c95793d07b1c12012-07-24
51672-1316-3GM - Gram51672-1316f55a994a-f1ed-4b3c-8a65-bc03913f385212012-07-24
51672-1316-6GM - Gram51672-1316e5eb658f-bc10-4590-9ebd-4d373c3c1b1912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Alclometasone dipropionateACTIVE INGREDIENTS56PQL4N1VALCLOMETASONE DIPROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
AlclometasoneACTIVE MOIETY136H45TB7BALCLOMETASONE DIPROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
hexylene glycolINACTIVE INGREDIENTKEH0A3F75JALCLOMETASONE DIPROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
petrolatumINACTIVE INGREDIENT4T6H12BN9UALCLOMETASONE DIPROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene glycol monostearateINACTIVE INGREDIENTF76354LMGRALCLOMETASONE DIPROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
white waxINACTIVE INGREDIENT7G1J5DA97FALCLOMETASONE DIPROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1316ALCLOMETASONE DIPROPIONATE OINTMENT [SUN PHARMACEUTICAL INDUSTRIES, INC.]4Current NDC, Legacy NDC, 7 package rows20250406_3b0dccd6-dee1-49dd-8c6d-82df5c7ee36c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855480alclometasone dipropionate 0.05 % Topical OintmentPSN3b0dccd6-dee1-49dd-8c6d-82df5c7ee36c6
855480alclometasone dipropionate 0.0005 MG/MG Topical OintmentSCD3b0dccd6-dee1-49dd-8c6d-82df5c7ee36c6
855480alclometasone dipropionate 0.05 % Topical OintmentSY3b0dccd6-dee1-49dd-8c6d-82df5c7ee36c6
855480alclometasone dipropionate 0.5 MG/GM Topical OintmentSY3b0dccd6-dee1-49dd-8c6d-82df5c7ee36c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1316-1516721316011 TUBE in 1 CARTON (51672-1316-1) / 15 g in 1 TUBE1 tube2004-07-290000-00-00NoNoCurrent
51672-1316-3516721316031 TUBE in 1 CARTON (51672-1316-3) / 60 g in 1 TUBE1 tube2004-07-290000-00-00NoNoCurrent
51672-1316-5516721316055 g in 1 TUBE (51672-1316-5) 5 g2004-07-290000-00-00NoNoCurrent
51672-1316-6516721316061 TUBE in 1 CARTON (51672-1316-6) / 45 g in 1 TUBE1 tube2004-07-290000-00-00NoNoCurrent