FDA.reportPublic FDA data

Xeglyze

Product NDC
43598-921
11-digit product format
435980921
Labeler code
43598
Product ID
43598-921_79de62dc-8192-24c3-df79-2e75a4b6c85b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
abametapir
Dosage form
LOTION
Route
TOPICAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
NDA206966
Marketing category
NDA
Marketing start
2021-01-29
Marketing end
0000-00-00
Substance
ABAMETAPIR
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43598-921IInactivated by FDA2026-08-03
excluded packagepackage43598-92143598-921-11IInactivated 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct43598-921IInactivated by FDAexcluded / ndc_excluded.zip8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage43598-92143598-921-11IInactivated by FDAexcluded / ndc_excluded.zip8dfbde2a14a4…c9ff85d89658…

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
N206966-001XEGLYZEABAMETAPIR0.74%LOTION / TOPICALRLD2020-07-24

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N206966-00178121632026-10-28U-2863Drug product2020-07-31
N206966-001102923892034-12-17U-2863Drug product2020-07-31

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-244b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-2487673890dc5c…
2021-03-12 10:30 UTC2021-03N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N206966-001XEGLYZE0.74%LOTION / TOPICALRLD, RS2020-07-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11N206966-001XEGLYZE0.74%LOTION / TOPICALRLD, RS2020-07-24c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-243f0d92c62455…
2023-05-13 08:27 UTC2023-05N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-24053a50430f4f…
2023-01-26 05:58 UTC2023-01N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-24cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N206966-001XEGLYZE0.74%LOTION / TOPICALRLD2020-07-24a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 5 · 167 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N206966-00178121632026-10-28U-2863Drug product2020-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206966-001102923892034-12-17U-2863Drug product2020-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206966-00178121632026-10-28U-2863Drug product2020-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206966-001102923892034-12-17U-2863Drug product2020-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N206966-00178121632026-10-28U-2863Drug product2020-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206966-001102923892034-12-17U-2863Drug product2020-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206966-00178121632026-10-28U-2863Drug product2020-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206966-001102923892034-12-17U-2863Drug product2020-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206966-00178121632026-10-28U-2863Drug product2020-07-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206966-001102923892034-12-17U-2863Drug product2020-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206966-00182120382024-07-16U-2863Drug product2020-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206966-00193577832024-07-16Drug product2020-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206966-00198396312024-07-16U-2863Drug substance, Drug product2020-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206966-00178121632026-10-28U-2863Drug product2020-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206966-001102923892034-12-17U-2863Drug product2020-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206966-00182120382024-07-16U-2863Drug product2020-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206966-00193577832024-07-16Drug product2020-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206966-00198396312024-07-16U-2863Drug substance, Drug product2020-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206966-00178121632026-10-28U-2863Drug product2020-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206966-001102923892034-12-17U-2863Drug product2020-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206966-00182120382024-07-16U-2863Drug product2020-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206966-00193577832024-07-16Drug product2020-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206966-00198396312024-07-16U-2863Drug substance, Drug product2020-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206966-00178121632026-10-28U-2863Drug product2020-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206966-001102923892034-12-17U-2863Drug product2020-07-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206966-00182120382024-07-16U-2863Drug product2020-07-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206966-00193577832024-07-16Drug product2020-07-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206966-00198396312024-07-16U-2863Drug substance, Drug product2020-07-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206966-00178121632026-10-28U-2863Drug product2020-07-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206966-001102923892034-12-17U-2863Drug product2020-07-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N206966-00182120382024-07-16U-2863Drug product2020-07-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N206966-00193577832024-07-16Drug product2020-07-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N206966-00198396312024-07-16U-2863Drug substance, Drug product2020-07-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N206966-00178121632026-10-28U-2863Drug product2020-07-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N206966-001102923892034-12-17U-2863Drug product2020-07-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206966-00182120382024-07-16U-2863Drug product2020-07-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206966-00193577832024-07-16Drug product2020-07-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206966-00198396312024-07-16U-2863Drug substance, Drug product2020-07-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206966-00178121632026-10-28U-2863Drug product2020-07-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206966-001102923892034-12-17U-2863Drug product2020-07-3179d66fd596c7…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206966-001NCE2025-07-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N206966-001NCE2025-07-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206966-001NCE2025-07-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206966-001NCE2025-07-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206966-001NCE2025-07-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206966-001NCE2025-07-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206966-001NCE2025-07-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206966-001NCE2025-07-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N206966-001NCE2025-07-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206966-001NCE2025-07-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206966-001NCE2025-07-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206966-001NCE2025-07-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N206966-001NCE2025-07-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206966-001NCE2025-07-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N206966-001NCE2025-07-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N206966-001NCE2025-07-244b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N206966-001NCE2025-07-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N206966-001NCE2025-07-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N206966-001NCE2025-07-2487673890dc5c…
2021-03-12 10:30 UTC2021-03N206966-001NCE2025-07-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N206966-001NCE2025-07-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11N206966-001NCE2025-07-31c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N206966-001NCE2025-07-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N206966-001NCE2025-07-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12N206966-001NCE2025-07-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N206966-001NCE2025-07-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N206966-001NCE2025-07-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N206966-001NCE2025-07-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N206966-001NCE2025-07-243f0d92c62455…
2023-05-13 08:27 UTC2023-05N206966-001NCE2025-07-24053a50430f4f…
2023-01-26 05:58 UTC2023-01N206966-001NCE2025-07-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N206966-001NCE2025-07-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N206966-001NCE2025-07-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N206966-001NCE2025-07-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N206966-001NCE2025-07-24cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83a78647-0546-4abc-9ca2-e99aaa264f72Product name120210204

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43598-921-112022-01-30C16284748780-1c7ccaba7-2aab-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use XEGLYZE TM safely and effectively. See full prescribing information for XEGLYZE. XEGLYZE (abametapir) lotion, for topical use Initial U.S. Approval: 2020
43598-921-112021-07-23C16284748780-1c7ccaba7-2aab-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use XEGLYZE TM safely and effectively. See full prescribing information for XEGLYZE. XEGLYZE (abametapir) lotion, for topical use Initial U.S. Approval: 2020

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-921-11Xeglyze1 in 1 CARTONLOTION14
43598-921-11Xeglyze200 g in 1 BOTTLELOTION2004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-921XEGLYZE (ABAMETAPIR ) LOTION [DR. REDDY'S LABORATORIES INC.]4Legacy NDC, 2 package rows20240731_4fe38e95-8738-a28f-4079-43eff7318cb9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2475536abametapir 0.74 % Topical LotionPSN4fe38e95-8738-a28f-4079-43eff7318cb94
2475541Xeglyze 0.74 % Topical LotionPSN4fe38e95-8738-a28f-4079-43eff7318cb94
2475541abametapir 7.4 MG/ML Topical Lotion [Xeglyze]SBD4fe38e95-8738-a28f-4079-43eff7318cb94
2475536abametapir 7.4 MG/ML Topical LotionSCD4fe38e95-8738-a28f-4079-43eff7318cb94
2475536abametapir 0.74 % Topical LotionSY4fe38e95-8738-a28f-4079-43eff7318cb94
2475541Xeglyze 0.74 % Topical LotionSY4fe38e95-8738-a28f-4079-43eff7318cb94
2475541Xeglyze 7.4 MG/ML Topical LotionSY4fe38e95-8738-a28f-4079-43eff7318cb94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-921-11435980921111 BOTTLE in 1 CARTON (43598-921-11) > 200 g in 1 BOTTLE1 bottle2021-01-290000-00-00NoNoCurrent