Ethambutol Hydrochloride

Product NDC
68084-280
11-digit product format
680840280
Labeler code
68084
Product ID
68084-280_3f1882fc-606c-8c87-e063-6294a90aa227
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ethambutol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA078939
Marketing category
ANDA
Marketing start
2009-12-16
Substance
ETHAMBUTOL HYDROCHLORIDE
Active strength
400 mg/1
Pharmacologic classes
Antimycobacterial [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ethambutol Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETHAMBUTOL HYDROCHLORIDE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQE4VW5FO07
Rxcui995607

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-280-01Ethambutol Hydrochloride100 in 1 BOX, UNIT-DOSETABLET1007
68084-280-11Ethambutol Hydrochloride1 in 1 BLISTER PACKTABLET17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-280-01EA - Each68084-2807b715fc6-1ed1-4d06-8e26-eefd3468e80512012-07-24
68084-280-11EA - Each68084-280b76fe659-1403-45f2-ac31-b78185dc859d12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-280ETHAMBUTOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]6Current NDC, Legacy NDC, 2 package rows20240806_d32e9865-8edd-4644-9939-62ed119db3ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995607ethambutol HCl 400 MG Oral TabletPSNd32e9865-8edd-4644-9939-62ed119db3ef7
995607ethambutol hydrochloride 400 MG Oral TabletSCDd32e9865-8edd-4644-9939-62ed119db3ef7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-280-0168084028001100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-280-01) / 1 TABLET in 1 BLISTER PACK (68084-280-11) 100 blister pack2009-12-160000-00-00NoNoCurrent
68084-280-11680840280111 in 1 BLISTER PACKHistorical