Ethambutol Hydrochloride

Product NDC
70518-3662
11-digit product format
705183662
Labeler code
70518
Product ID
70518-3662_5026dd14-3847-f96a-e063-6294a90ab8ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ethambutol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078939
Marketing category
ANDA
Marketing start
2023-02-26
Substance
ETHAMBUTOL HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQE4VW5FO07
Rxcui995599

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
70518-3662-0Ethambutol Hydrochloride30 in 1 BLISTER PACKTABLET305
70518-3662-1Ethambutol Hydrochloride50 in 1 BOXTABLET505
70518-3662-2Ethambutol Hydrochloride1 in 1 POUCHTABLET15

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995599ethambutol HCl 100 MG Oral TabletPSNe0d4a594-d3e0-47b0-9f11-f4dbd4552d5a5
995599ethambutol hydrochloride 100 MG Oral TabletSCDe0d4a594-d3e0-47b0-9f11-f4dbd4552d5a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3662-07051836620030 in 1 BLISTER PACKHistorical
70518-3662-17051836620150 POUCH in 1 BOX (70518-3662-1) / 1 TABLET in 1 POUCH (70518-3662-2) 50 pouch2026-04-23NoNoHistorical
70518-3662-2705183662021 in 1 POUCHHistorical