Clobetasol Propionate

Product NDC
51672-4193
11-digit product format
516724193
Labeler code
51672
Product ID
51672-4193_28793ebc-59fc-55da-e063-6394a90ac651
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA208779
Marketing category
ANDA
Marketing start
2018-10-04
Substance
CLOBETASOL PROPIONATE
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 42.

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
A208779-001CLOBETASOL PROPIONATECLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB1RS2018-10-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208779-001AB1

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB1RS2018-10-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB1RS2018-10-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB1RS2018-10-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB1RS2018-10-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB1RS2018-10-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB1RS2018-10-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB1RS2018-10-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB1RS2018-10-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB1RS2018-10-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB1RS2018-10-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB1RS2018-10-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB1RS2018-10-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB1RS2018-10-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB1RS2018-10-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB1RS2018-10-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12018-10-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12018-10-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12018-10-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12018-10-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12018-10-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12018-10-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12018-10-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12018-10-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12018-10-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12018-10-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12018-10-043f01610625f2…
2019-09-15 20:21 UTC2019-09A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12018-10-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12018-10-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB1RS2018-10-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB1RS2018-10-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB1RS2018-10-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12018-10-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12018-10-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12018-10-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12018-10-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12018-10-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12018-10-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12018-10-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12018-10-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208779-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12018-10-04e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A208779-001AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208779-001AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208779-001AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208779-001AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208779-001AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208779-001AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208779-001AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208779-001AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208779-001AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208779-001AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208779-001AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208779-001AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208779-001AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208779-001AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208779-001AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208779-001AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208779-001AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208779-001AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208779-001AB1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208779-001AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208779-001AB11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208779-001AB1187673890dc5c…
2021-03-12 10:30 UTC2021-03A208779-001AB115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208779-001AB118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208779-001AB11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208779-001AB113f01610625f2…
2019-09-15 20:21 UTC2019-09A208779-001AB11b00525d2431f…
2019-07-19 19:46 UTC2019-07A208779-001AB11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208779-001AB116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208779-001AB111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208779-001AB11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208779-001AB11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208779-001AB119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208779-001AB11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208779-001AB113f0d92c62455…
2023-05-13 08:27 UTC2023-05A208779-001AB11053a50430f4f…
2023-01-26 05:58 UTC2023-01A208779-001AB113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208779-001AB113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208779-001AB11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208779-001AB11e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Clobetasol Propionate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOBETASOL PROPIONATE.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
779619577MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
861353Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d8f560c8-e223-46f0-8afb-b418f2b6399cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
20abe2c3-3e80-d2b2-39eb-3156e4af4799Product name320250124
45ad92f8-d116-4c0c-851c-2e740b7d8e6fProduct name120250122
42be0ad5-6fd7-4f1b-8108-6d9dd7d571dfProduct name720250107
3813b789-94b9-edd6-f010-6b926dd462e5Product name520230113
30eee8a1-850e-41ed-b5ab-761301aeab49Product name620221206
18e5b6f7-c414-b1f1-b684-17fdd02c215eProduct name420210927
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
1c87bbde-dd91-a122-db33-67ae814cb645Product name720210510
519b5875-7d7d-4aa6-9d3d-470fa1376595Product name420200227
98669154-3e9c-47da-8a2c-656ab71848beProduct name220180607
8d4f8539-436f-453b-8b76-5322d403fc8eProduct name120180131
837ac3c6-ee71-c5a6-6eba-c4065f37e9f5Product name220171010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4193-3Clobetasol Propionate1 in 1 CARTONAEROSOL, FOAM13
51672-4193-3Clobetasol Propionate50 g in 1 CANAEROSOL, FOAM503
51672-4193-7Clobetasol Propionate1 in 1 CARTONAEROSOL, FOAM13
51672-4193-7Clobetasol Propionate100 g in 1 CANAEROSOL, FOAM1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4193-3GM - Gram51672-419383aa371a-7021-44e6-80f6-93bd6fee46d112018-11-06
51672-4193-7GM - Gram51672-41930f1df028-e357-4d58-b8c8-6f67e84f889912018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4193CLOBETASOL PROPIONATE AEROSOL, FOAM [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 4 package rows20241207_d8f560c8-e223-46f0-8afb-b418f2b6399c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clobetasol PropionateCLOBETASOL PROPIONATESun Pharmaceutical Industries, Inc.d8f560c8-e223-46f0-8afb-b418f2b6399c2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208779
application number: ANDA208779
ndc (product): 51672-4193

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861353clobetasol propionate 0.05 % Topical FoamPSNd8f560c8-e223-46f0-8afb-b418f2b6399c3
861353clobetasol propionate 0.5 MG/ML Topical FoamSCDd8f560c8-e223-46f0-8afb-b418f2b6399c3
861353clobetasol propionate 0.05 % Topical FoamSYd8f560c8-e223-46f0-8afb-b418f2b6399c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4193-3516724193031 CAN in 1 CARTON (51672-4193-3) / 50 g in 1 CAN1 can2018-10-040000-00-00NoNoCurrent
51672-4193-7516724193071 CAN in 1 CARTON (51672-4193-7) / 100 g in 1 CAN1 can2018-10-040000-00-00NoNoCurrent