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

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