Ethambutol Hydrochloride

Product NDC
55695-035
11-digit product format
556950035
Labeler code
55695
Product ID
55695-035_2b867b73-de21-2bc2-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ethambutol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Department of State Health Services, Pharmacy Branch
Application
NDA016320
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2006-12-15
Marketing end
0000-00-00
Substance
ETHAMBUTOL HYDROCHLORIDE
Active strength
400 mg/1
Pharmacologic classes
Antimycobacterial [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
e86e15b7-896a-6fb4-16e3-cf6efd994b64Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55695-035-002020-01-31C16284748780-19d75b9d1-0ec4-f424-e053-dadaa90a57ceEthambutol Hydrochloride TABLETS USP 100 mg and 400 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55695-035-00Ethambutol Hydrochloride12 in 1 BOXTABLET, FILM COATED121
55695-035-00Ethambutol Hydrochloride12 in 1 CARTONTABLET, FILM COATED121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55695-035ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [DEPARTMENT OF STATE HEALTH SERVICES, PHARMACY BRANCH]1Legacy NDC, 2 package rows20160311_2b867b73-de36-2bc2-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995599ethambutol HCl 100 MG Oral TabletPSN2b867b73-de36-2bc2-e054-00144ff88e881
995607ethambutol HCl 400 MG Oral TabletPSN2b867b73-de36-2bc2-e054-00144ff88e881
995599ethambutol hydrochloride 100 MG Oral TabletSCD2b867b73-de36-2bc2-e054-00144ff88e881
995607ethambutol hydrochloride 400 MG Oral TabletSCD2b867b73-de36-2bc2-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55695-035-005569500350012 in 1 BOXHistorical