FDA.reportPublic FDA data

Alclometasone Dipropionate

Product NDC
0168-0263
11-digit product format
001680263
Labeler code
0168
Product ID
0168-0263_901e10b7-2784-49c4-8e56-1c461aaad927
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alclometasone dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application
ANDA076973
Marketing category
ANDA
Marketing start
2005-07-12
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

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
A076973-001ALCLOMETASONE DIPROPIONATEALCLOMETASONE DIPROPIONATE0.05%CREAM / TOPICALABRS2005-07-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076973-001AB

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 22:54:322026-06A076973-001ALCLOMETASONE DIPROPIONATE0.05%CREAM / TOPICALABRS2005-07-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076973-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alclometasone DipropionateALCLOMETASONE DIPROPIONATEE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.6aacce3f-aa2f-4f2c-a5bd-8cff157a3dab2025-07-09Adverse reactionsExact identifier
application applno (ANDA): 076973
application number: ANDA076973
ndc (product): 0168-0263

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S56PQL4N1VInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855474Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6aacce3f-aa2f-4f2c-a5bd-8cff157a3dabAvailable on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0168-0263-152025-08-11C16284748780-1ab0e2407-2f06-f274-e053-dbdaa90a6471ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05%
0168-0263-452025-08-11C16284748780-1ab0e2407-2f06-f274-e053-dbdaa90a6471ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05%
0168-0263-602025-08-11C16284748780-1ab0e2407-2f06-f274-e053-dbdaa90a6471ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05%
0168-0263-152025-07-29C16284748780-1ab0e2407-2f06-f274-e053-dbdaa90a6471ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05%
0168-0263-452025-07-29C16284748780-1ab0e2407-2f06-f274-e053-dbdaa90a6471ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05%
0168-0263-602025-07-29C16284748780-1ab0e2407-2f06-f274-e053-dbdaa90a6471ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05%
0168-0263-152020-09-16C16284748780-1ab0e2407-2f06-f274-e053-dbdaa90a6471ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05%
0168-0263-452020-09-16C16284748780-1ab0e2407-2f06-f274-e053-dbdaa90a6471ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05%
0168-0263-602020-09-16C16284748780-1ab0e2407-2f06-f274-e053-dbdaa90a6471ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05%
0168-0263-152020-07-22C16284748780-1ab0e2407-2f06-f274-e053-dbdaa90a6471ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05%
0168-0263-452020-07-22C16284748780-1ab0e2407-2f06-f274-e053-dbdaa90a6471ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05%
0168-0263-602020-07-22C16284748780-1ab0e2407-2f06-f274-e053-dbdaa90a6471ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0168-0263-15Alclometasone Dipropionate15 g in 1 TUBECREAM158
0168-0263-45Alclometasone Dipropionate45 g in 1 TUBECREAM458
0168-0263-60Alclometasone Dipropionate60 g in 1 TUBECREAM608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0263-15GM - Gram0168-02636494524e-6114-4653-a9e4-145fb8e36d7712012-07-24
0168-0263-45GM - Gram0168-02631d28335c-8e5c-4383-b317-cb9f4943cd7e12012-07-24
0168-0263-60GM - Gram0168-0263c5fbb46d-368e-4704-8f0b-a5dc89306cac12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCLOMETASONE DIPROPIONATEACTIVE INGREDIENTS56PQL4N1VALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
ALCLOMETASONEACTIVE MOIETY136H45TB7BALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
CETETH-20INACTIVE INGREDIENTI835H2IHHXALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
CHLOROCRESOLINACTIVE INGREDIENT36W53O7109ALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4ALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
POLYETHYLENE GLYCOL 4500INACTIVE INGREDIENTTVH7653921ALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0263ALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 3 package rows20200917_6aacce3f-aa2f-4f2c-a5bd-8cff157a3dab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855474alclometasone dipropionate 0.05 % Topical CreamPSN6aacce3f-aa2f-4f2c-a5bd-8cff157a3dab8
855474alclometasone dipropionate 0.5 MG/ML Topical CreamSCD6aacce3f-aa2f-4f2c-a5bd-8cff157a3dab8
855474alclometasone dipropionate 0.05 % Topical CreamSY6aacce3f-aa2f-4f2c-a5bd-8cff157a3dab8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0263-150016802631515 g in 1 TUBE (0168-0263-15) 15 g2005-07-120000-00-00NoNoCurrent
0168-0263-450016802634545 g in 1 TUBE (0168-0263-45) 45 g2005-07-120000-00-00NoNoCurrent
0168-0263-600016802636060 g in 1 TUBE (0168-0263-60) 60 g2005-07-120000-00-00NoNoCurrent