Clobetasol Propionate

Product NDC
45802-437
11-digit product format
458020437
Labeler code
45802
Product ID
45802-437_b6daaa57-be91-4dc3-9cc4-aeb6402241ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol propionate
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA077763
Marketing category
ANDA
Marketing start
2008-03-20
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 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
A077763-001CLOBETASOL PROPIONATECLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077763-001AB1

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 · 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 UTC2026-02A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-103f01610625f2…
2019-09-15 20:21 UTC2019-09A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077763-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB12008-03-10cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077763-001AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077763-001AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077763-001AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077763-001AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077763-001AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077763-001AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077763-001AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077763-001AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077763-001AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077763-001AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077763-001AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077763-001AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077763-001AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077763-001AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077763-001AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077763-001AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077763-001AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077763-001AB1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077763-001AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077763-001AB11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077763-001AB1187673890dc5c…
2021-03-12 10:30 UTC2021-03A077763-001AB115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077763-001AB118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077763-001AB11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077763-001AB113f01610625f2…
2019-09-15 20:21 UTC2019-09A077763-001AB11b00525d2431f…
2019-07-19 19:46 UTC2019-07A077763-001AB11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077763-001AB116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077763-001AB111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077763-001AB11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077763-001AB11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077763-001AB119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077763-001AB11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077763-001AB113f0d92c62455…
2023-05-13 08:27 UTC2023-05A077763-001AB11053a50430f4f…
2023-01-26 05:58 UTC2023-01A077763-001AB113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077763-001AB113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077763-001AB11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077763-001AB11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077763-001AB11cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Clobetasol Propionate
Listing expiration
2026-12-31

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
3f75880b-9ead-4c6e-b999-3bd7e1643ce5Available 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
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
45802-437-32Clobetasol Propionate50 g in 1 CANAEROSOL, FOAM507
45802-437-32Clobetasol Propionate1 in 1 CARTONAEROSOL, FOAM17
45802-437-33Clobetasol Propionate100 g in 1 CANAEROSOL, FOAM1007
45802-437-33Clobetasol Propionate1 in 1 CARTONAEROSOL, FOAM17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-437-32GM - Gram45802-437be16bf5a-de20-40e6-a709-38da4c1be6ca12012-07-24
45802-437-33GM - Gram45802-43733b18ba7-fb51-4916-9622-d2ea1d49dca212012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-437CLOBETASOL PROPIONATE AEROSOL, FOAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]7Current NDC, Legacy NDC, 4 package rows20230301_3f75880b-9ead-4c6e-b999-3bd7e1643ce5.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clobetasol PropionateCLOBETASOL PROPIONATEBryant Ranch Prepacka178bb79-c0dc-4561-93df-8f7bd9d57bae2024-01-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077763
application number: ANDA077763
Clobetasol PropionateCLOBETASOL PROPIONATEPadagis Israel Pharmaceuticals Ltd3f75880b-9ead-4c6e-b999-3bd7e1643ce52022-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077763
application number: ANDA077763
ndc (product): 45802-437

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861353clobetasol propionate 0.05 % Topical FoamPSNa178bb79-c0dc-4561-93df-8f7bd9d57bae101
861353clobetasol propionate 0.5 MG/ML Topical FoamSCDa178bb79-c0dc-4561-93df-8f7bd9d57bae101
861353clobetasol propionate 0.05 % Topical FoamSYa178bb79-c0dc-4561-93df-8f7bd9d57bae101
861353clobetasol propionate 0.05 % Topical FoamPSN3f75880b-9ead-4c6e-b999-3bd7e1643ce57
861353clobetasol propionate 0.5 MG/ML Topical FoamSCD3f75880b-9ead-4c6e-b999-3bd7e1643ce57
861353clobetasol propionate 0.05 % Topical FoamSY3f75880b-9ead-4c6e-b999-3bd7e1643ce57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-437-32458020437321 CAN in 1 CARTON (45802-437-32) / 50 g in 1 CAN1 can2008-03-200000-00-00NoNoCurrent
45802-437-33458020437331 CAN in 1 CARTON (45802-437-33) / 100 g in 1 CAN1 can2008-03-200000-00-00NoNoCurrent