clobetasol propionate

Product NDC
0781-7137
Requested package NDC
0781-7137-04
11-digit product format
007817137
Labeler code
0781
Product ID
0781-7137_dc343075-10a8-439d-9eb2-a2e760b402a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobetasol propionate
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Sandoz Inc.
Application
NDA021644
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2011-12-22
Marketing end
2022-04-30
Substance
CLOBETASOL PROPIONATE
Active strength
0 g/100mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0781-71370781-7137-04DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
N021644-001CLOBEXCLOBETASOL PROPIONATE0.05%SHAMPOO / TOPICALABRLD, RS2004-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021644-001AB

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.

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 UTC2026-02N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-0587673890dc5c…
2021-03-12 10:30 UTC2021-03N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-053f01610625f2…
2019-09-15 20:21 UTC2019-09N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-05b00525d2431f…
2019-07-19 19:46 UTC2019-07N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-053f0d92c62455…
2023-05-13 08:27 UTC2023-05N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-05053a50430f4f…
2023-01-26 05:58 UTC2023-01N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021644-001CLOBEX0.05%SHAMPOO / TOPICALABRLD, RS2004-02-05cb3db0bc1861…

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 UTC2026-02N021644-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021644-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021644-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021644-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021644-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021644-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021644-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021644-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021644-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021644-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021644-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021644-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021644-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021644-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021644-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021644-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021644-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021644-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021644-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021644-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021644-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021644-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021644-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021644-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021644-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021644-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021644-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021644-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021644-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021644-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021644-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021644-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021644-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021644-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021644-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021644-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021644-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021644-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021644-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021644-001AB1cb3db0bc1861…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021644-00177000812022-01-03U-10445c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021644-00177000812022-01-03U-10445d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021644-00177000812022-01-03U-10444b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021644-00173168102019-06-17Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021644-00180669752019-06-17Drug product2011-12-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021644-00180669762019-06-17Drug product2011-12-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021644-00177000812022-01-03U-104474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021644-00177000812022-01-03U-1044bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021644-00177000812022-01-03U-1044782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021644-00177000812022-01-03U-104487673890dc5c…
2021-03-12 10:30 UTC2021-03N021644-00177000812022-01-03U-10445aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021644-00177000812022-01-03U-10448869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021644-00177000812022-01-03U-1044c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021644-00173168102019-06-17Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021644-00180669752019-06-17Drug product2011-12-053f01610625f2…
2019-12-14 00:12 UTC2019-12N021644-00180669762019-06-17Drug product2011-12-053f01610625f2…
2019-12-14 00:12 UTC2019-12N021644-00177000812022-01-03U-10443f01610625f2…
2019-09-15 20:21 UTC2019-09N021644-00173168102019-06-17Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021644-00180669752019-06-17Drug product2011-12-05b00525d2431f…
2019-09-15 20:21 UTC2019-09N021644-00180669762019-06-17Drug product2011-12-05b00525d2431f…
2019-09-15 20:21 UTC2019-09N021644-00177000812022-01-03U-1044b00525d2431f…
2019-07-19 19:46 UTC2019-07N021644-00173168102019-06-17Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021644-00180669752019-06-17Drug product2011-12-05ea99ee380514…
2019-07-19 19:46 UTC2019-07N021644-00180669762019-06-17Drug product2011-12-05ea99ee380514…
2019-07-19 19:46 UTC2019-07N021644-00177000812022-01-03U-1044ea99ee380514…
2023-01-26 05:58 UTC2023-01N021644-00177000812022-01-03U-10443bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021644-00177000812022-01-03U-10443a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021644-00177000812022-01-03U-1044f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021644-00177000812022-01-03U-1044e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021644-00177000812022-01-03U-1044cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-7137-04ML - Milliliter0781-713708d0f3c8-1ad5-4dd9-b1c8-7c5c624a361f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOBETASOL PROPIONATEACTIVE INGREDIENT779619577MCLOBETASOL PROPIONATE SHAMPOO [SANDOZ INC.]4
CLOBETASOLACTIVE MOIETYADN79D536HCLOBETASOL PROPIONATE SHAMPOO [SANDOZ INC.]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MCLOBETASOL PROPIONATE SHAMPOO [SANDOZ INC.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCLOBETASOL PROPIONATE SHAMPOO [SANDOZ INC.]4
COCO-BETAINEINACTIVE INGREDIENT03DH2IZ3FYCLOBETASOL PROPIONATE SHAMPOO [SANDOZ INC.]4
POLYQUATERNIUM-10 (400 MPA.S AT 2%)INACTIVE INGREDIENTHB1401PQFSCLOBETASOL PROPIONATE SHAMPOO [SANDOZ INC.]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCLOBETASOL PROPIONATE SHAMPOO [SANDOZ INC.]4
SODIUM LAURETH-3 SULFATEINACTIVE INGREDIENTBPV390UAP0CLOBETASOL PROPIONATE SHAMPOO [SANDOZ INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RCLOBETASOL PROPIONATE SHAMPOO [SANDOZ INC.]4

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 PROPIONATEMayne Pharma Inc.524397b3-84c4-49d7-af5e-bb229dfee68b2023-08-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 021644
application number: NDA021644

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-7137-04007817137041 BOTTLE in 1 CARTON (0781-7137-04) > 118 mL in 1 BOTTLE1 bottle2012-01-042022-04-30NoNoCurrent