FDA.reportPublic FDA data

Alclometasone Dipropionate

Product NDC
0168-0264
Requested package NDC
0168-0264-15
11-digit product format
001680264
Labeler code
0168
Product ID
0168-0264_f4b24fb7-96bb-4c9a-b1a0-e66f909553f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alclometasone dipropionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application
ANDA076884
Marketing category
ANDA
Marketing start
2005-07-18
Marketing end
0000-00-00
Substance
ALCLOMETASONE DIPROPIONATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0168-02640168-0264-15DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076884-001ALCLOMETASONE DIPROPIONATEALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALABRS2005-07-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A076884-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A076884-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALABRS2005-07-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076884-001AB1a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0168-0264-152020-09-03C16284748780-1ab0e2407-33ee-f274-e053-dbdaa90a6471ALCLOMETASONE DIPROPIONATE OINTMENT USP, 0.05%
0168-0264-452020-09-03C16284748780-1ab0e2407-33ee-f274-e053-dbdaa90a6471ALCLOMETASONE DIPROPIONATE OINTMENT USP, 0.05%
0168-0264-602020-09-03C16284748780-1ab0e2407-33ee-f274-e053-dbdaa90a6471ALCLOMETASONE DIPROPIONATE OINTMENT USP, 0.05%
0168-0264-152020-07-22C16284748780-1ab0e2407-33ee-f274-e053-dbdaa90a6471ALCLOMETASONE DIPROPIONATE OINTMENT USP, 0.05%
0168-0264-452020-07-22C16284748780-1ab0e2407-33ee-f274-e053-dbdaa90a6471ALCLOMETASONE DIPROPIONATE OINTMENT USP, 0.05%
0168-0264-602020-07-22C16284748780-1ab0e2407-33ee-f274-e053-dbdaa90a6471ALCLOMETASONE DIPROPIONATE OINTMENT USP, 0.05%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0264-15GM - Gram0168-0264c868d18c-8e0b-4d16-8720-f445fd71777912012-07-24
0168-0264-45GM - Gram0168-026449347979-d920-4b48-975b-079e0aa5804012012-07-24
0168-0264-60GM - Gram0168-026428d32605-d36f-4633-bd3f-eadb7c3bc6c512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCLOMETASONE DIPROPIONATEACTIVE INGREDIENTS56PQL4N1VALCLOMETASONE DIPROPIONATE OINTMENT [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
ALCLOMETASONEACTIVE MOIETY136H45TB7BALCLOMETASONE DIPROPIONATE OINTMENT [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JALCLOMETASONE DIPROPIONATE OINTMENT [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UALCLOMETASONE DIPROPIONATE OINTMENT [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
PROPYLENE GLYCOL STEARATEINACTIVE INGREDIENTMZM1I680W0ALCLOMETASONE DIPROPIONATE OINTMENT [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FALCLOMETASONE DIPROPIONATE OINTMENT [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0264-15001680264151 TUBE in 1 CARTON (0168-0264-15) > 15 g in 1 TUBE1 tube2005-07-180000-00-00NoNoCurrent