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

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
A079227-001ALCLOMETASONE DIPROPIONATEALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICAL2009-07-30

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICAL2009-07-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICAL2009-07-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICAL2009-07-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-303f01610625f2…
2019-09-15 20:21 UTC2019-09A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079227-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALAB2009-07-30cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079227-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079227-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079227-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079227-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079227-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079227-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079227-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079227-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079227-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079227-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079227-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079227-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079227-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079227-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079227-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079227-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079227-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079227-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A079227-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079227-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079227-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079227-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A079227-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A079227-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079227-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079227-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079227-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079227-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079227-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079227-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079227-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A079227-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A079227-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079227-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079227-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079227-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079227-001AB1cb3db0bc1861…

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 DIPROPIONATEGlenmark Pharmaceuticals Inc., USA63e635e0-65d8-4b30-9f2a-ab16deba90bd2021-04-05Adverse reactionsExact identifier
application applno (ANDA): 079227
application number: ANDA079227
ndc (product): 68462-299

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855474Internal RxNorm lookup
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
63e635e0-65d8-4b30-9f2a-ab16deba90bdAvailable on FDA.report

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