ETHAMBUTOL HYDROCHLORIDE

Product NDC
42806-102
11-digit product format
428060102
Labeler code
42806
Product ID
42806-102_a5247287-041a-4548-9a24-aadbfd233459
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ETHAMBUTOL HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA075095
Marketing category
ANDA
Marketing start
2015-03-18
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
Rxcui995599, 995607

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
42806-102-01ETHAMBUTOL HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-102-01EA - Each42806-1022dec421f-1a1c-44af-a2a5-c1a61311ae0812020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-102ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]4Current NDC, Legacy NDC, 1 package rows20231221_08decdf3-a397-42e7-8ac3-e489c0cc7085.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995599ethambutol HCl 100 MG Oral TabletPSN08decdf3-a397-42e7-8ac3-e489c0cc70854
995607ethambutol HCl 400 MG Oral TabletPSN08decdf3-a397-42e7-8ac3-e489c0cc70854
995599ethambutol hydrochloride 100 MG Oral TabletSCD08decdf3-a397-42e7-8ac3-e489c0cc70854
995607ethambutol hydrochloride 400 MG Oral TabletSCD08decdf3-a397-42e7-8ac3-e489c0cc70854

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42806-102-0142806010201100 TABLET, FILM COATED in 1 BOTTLE (42806-102-01) 2020-07-300000-00-00NoNoCurrent