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

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
A076730-001ALCLOMETASONE DIPROPIONATEALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2004-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076730-001AB

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 22:54:322026-06A076730-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2004-07-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076730-001AB1a50c72e98297…

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 DIPROPIONATESun Pharmaceutical Industries, Inc.3b0dccd6-dee1-49dd-8c6d-82df5c7ee36c2025-08-13Adverse reactionsExact identifier
application applno (ANDA): 076730
application number: ANDA076730
ndc (product): 51672-1316

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
855480Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3b0dccd6-dee1-49dd-8c6d-82df5c7ee36cAvailable on FDA.report

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