clocortolone pivalate

Product NDC
43598-341
11-digit product format
435980341
Labeler code
43598
Product ID
43598-341_c476d39c-4622-e3bf-d781-a880816c4cbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clocortolone pivalate
Dosage form
CREAM
Route
TOPICAL
Labeler
Dr. Reddy's Laboratories Inc
Application
NDA017765
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-02-17
Marketing end
0000-00-00
Substance
CLOCORTOLONE PIVALATE
Active strength
0 g/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43598-341IInactivated by FDA2026-08-03
excluded packagepackage43598-34143598-341-45IInactivated by FDA2026-08-03
excluded packagepackage43598-34143598-341-75IInactivated by FDA2026-08-03
excluded packagepackage43598-34143598-341-90IInactivated by FDA2026-08-03

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43598-341-45IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43598-341-75IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43598-341-90IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43598-341-45IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43598-341-75IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43598-341-90IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43598-341-45IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43598-341-75IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43598-341-90IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43598-341-45IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43598-341-75IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43598-341-90IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43598-341-45IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43598-341-75IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43598-341-90IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43598-341-45IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43598-341-75IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43598-341-90IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43598-341-75UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43598-341-90UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43598-341-45UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43598-341-75UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43598-341-90UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43598-341-45UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43598-341-75UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43598-341-90UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43598-341-45UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
N017765-001CLODERMCLOCORTOLONE PIVALATE0.1%CREAM / TOPICALABRLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N017765-001AB

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 UTC2026-02N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017765-001CLODERM0.1%CREAM / TOPICALRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017765-001CLODERM0.1%CREAM / TOPICALRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017765-001CLODERM0.1%CREAM / TOPICALRLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N017765-001CLODERM0.1%CREAM / TOPICALRLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017765-001CLODERM0.1%CREAM / TOPICALRLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017765-001CLODERM0.1%CREAM / TOPICALRLD, RS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N017765-001CLODERM0.1%CREAM / TOPICALRLD, RS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N017765-001CLODERM0.1%CREAM / TOPICALRLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017765-001CLODERM0.1%CREAM / TOPICALABRLD, RS, Approved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N017765-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017765-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017765-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017765-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017765-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017765-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017765-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017765-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017765-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017765-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017765-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017765-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017765-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017765-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017765-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017765-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017765-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N017765-001AB1bb7c543d1eb4…
2020-11-12 02:37 UTC2020-11N017765-001AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017765-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017765-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017765-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017765-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017765-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017765-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017765-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N017765-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N017765-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017765-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017765-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017765-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017765-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017765-001AB1a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5b4db253-13f4-a186-daf6-9b4e39d96457Product name220200729

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-341-45clocortolone pivalate1 in 1 CARTONCREAM15
43598-341-45clocortolone pivalate45 g in 1 TUBECREAM455
43598-341-75clocortolone pivalate1 in 1 CARTONCREAM15
43598-341-75clocortolone pivalate75 g in 1 BOTTLE, PUMPCREAM755
43598-341-90clocortolone pivalate90 g in 1 TUBECREAM905
43598-341-90clocortolone pivalate1 in 1 CARTONCREAM15

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-341CLOCORTOLONE PIVALATE CREAM [DR. REDDY'S LABORATORIES INC]5Legacy NDC, 6 package rows20190913_1eae193c-5cfd-5db1-344a-c951e2c9eff8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197520clocortolone (as clocortolone pivalate) 0.1 % Topical CreamPSN1eae193c-5cfd-5db1-344a-c951e2c9eff85
197520clocortolone 1 MG/ML Topical CreamSCD1eae193c-5cfd-5db1-344a-c951e2c9eff85
197520clocortolone (as clocortolone pivalate) 0.1 % Topical CreamSY1eae193c-5cfd-5db1-344a-c951e2c9eff85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-341-45435980341451 TUBE in 1 CARTON (43598-341-45) > 45 g in 1 TUBE1 tube2014-02-170000-00-00NoNoCurrent
43598-341-75435980341751 BOTTLE, PUMP in 1 CARTON (43598-341-75) > 75 g in 1 BOTTLE, PUMP2014-02-170000-00-00NoNoCurrent
43598-341-90435980341901 TUBE in 1 CARTON (43598-341-90) > 90 g in 1 TUBE1 tube2014-02-170000-00-00NoNoCurrent