Ethambutol Hydrochloride

Product NDC
70518-2966
11-digit product format
705182966
Labeler code
70518
Product ID
70518-2966_4aba550b-837b-4af9-e063-6394a90af074
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ethambutol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078939
Marketing category
ANDA
Marketing start
2020-12-11
Substance
ETHAMBUTOL HYDROCHLORIDE
Active strength
400 mg/1
Pharmacologic classes
Antimycobacterial [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ethambutol Hydrochloride
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2966-0Ethambutol Hydrochloride30 in 1 BLISTER PACKTABLET3012
70518-2966-1Ethambutol Hydrochloride100 in 1 BOXTABLET10012
70518-2966-2Ethambutol Hydrochloride1 in 1 POUCHTABLET112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2966ETHAMBUTOL HYDROCHLORIDE TABLET [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 3 package rows20250409_c12b3482-55f0-4324-bdcd-b129ca2dae73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995607ethambutol HCl 400 MG Oral TabletPSNc12b3482-55f0-4324-bdcd-b129ca2dae7312
995607ethambutol hydrochloride 400 MG Oral TabletSCDc12b3482-55f0-4324-bdcd-b129ca2dae7312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2966-07051829660030 TABLET in 1 BLISTER PACK (70518-2966-0) 30 tablet2020-12-110000-00-00NoNoCurrent
70518-2966-170518296601100 in 1 BOXHistorical
70518-2966-2705182966021 in 1 POUCHHistorical