Ethambutol Hydrochloride

Product NDC
53808-0977
11-digit product format
538080977
Labeler code
53808
Product ID
53808-0977_7287877c-326f-4bf6-8dd8-3d99b6364bb6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ETHAMBUTOL HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA016320
Marketing category
NDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
ETHAMBUTOL HYDROCHLORIDE
Active strength
400 mg/1
Pharmacologic classes
Antimycobacterial [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
53808-0977-12019-10-21C16284748780-1956f9ecf-ceb2-621f-e053-dbdaa90a74adETHAMBUTOL HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0977-1Ethambutol Hydrochloride30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHAMBUTOL HYDROCHLORIDEACTIVE INGREDIENTQE4VW5FO07ETHAMBUTOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ETHAMBUTOLACTIVE MOIETY8G167061QZETHAMBUTOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GELATININACTIVE INGREDIENT2G86QN327LETHAMBUTOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYMETHYL CELLULOSEINACTIVE INGREDIENT273FM27VK1ETHAMBUTOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ETHAMBUTOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEETHAMBUTOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AETHAMBUTOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ETHAMBUTOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JETHAMBUTOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APETHAMBUTOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SUCROSEINACTIVE INGREDIENTC151H8M554ETHAMBUTOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETHAMBUTOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIACETININACTIVE INGREDIENTXHX3C3X673ETHAMBUTOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0977ETHAMBUTOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100614_2f857930-d002-4abe-9907-bfd8fd7fe5ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995607ethambutol HCl 400 MG Oral TabletPSN2f857930-d002-4abe-9907-bfd8fd7fe5ed1
995607ethambutol hydrochloride 400 MG Oral TabletSCD2f857930-d002-4abe-9907-bfd8fd7fe5ed1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0977-15380809770130 in 1 BLISTER PACKHistorical