Ethambutol Hydrochloride

Product NDC
50090-3948
11-digit product format
500903948
Labeler code
50090
Product ID
50090-3948_1055007a-4eca-45c8-8f28-7373798cb28e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ethambutol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075095
Marketing category
ANDA
Marketing start
2015-03-18
Marketing end
0000-00-00
Substance
ETHAMBUTOL HYDROCHLORIDE
Active strength
400 mg/1
Pharmacologic classes
Antimycobacterial [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e86e15b7-896a-6fb4-16e3-cf6efd994b64Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3948-02023-01-30C16284748780-1f386c649-a7c4-0266-e053-dadaa90a7c1aETHAMBUTOL HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3948-0Ethambutol Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3948ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]4Legacy NDC, 1 package rows20200121_b48756dd-582d-4e4f-9b65-70a797c8ac6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995607ethambutol HCl 400 MG Oral TabletPSNb48756dd-582d-4e4f-9b65-70a797c8ac6a4
995607ethambutol hydrochloride 400 MG Oral TabletSCDb48756dd-582d-4e4f-9b65-70a797c8ac6a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3948-050090394800100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3948-0) 2018-12-110000-00-00NoNoCurrent