Ethambutol Hydrochloride

Product NDC
68180-281
11-digit product format
681800281
Labeler code
68180
Product ID
68180-281_b76b5b09-9d5d-4343-b128-0266024919b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ethambutol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA078939
Marketing category
ANDA
Marketing start
2009-07-04
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
68180-281-01Ethambutol Hydrochloride100 in 1 BOTTLETABLET10011
68180-281-02Ethambutol Hydrochloride500 in 1 BOTTLETABLET50011
68180-281-11Ethambutol Hydrochloride14 in 1 BLISTER PACKTABLET1411

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-281-01EA - Each68180-2812e29e44f-1d57-4a33-9dfe-ea9a49b5b7b312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHAMBUTOL HYDROCHLORIDEACTIVE INGREDIENTQE4VW5FO07ETHAMBUTOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
ETHAMBUTOLACTIVE MOIETY8G167061QZETHAMBUTOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BETHAMBUTOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOETHAMBUTOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ETHAMBUTOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AETHAMBUTOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EETHAMBUTOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ETHAMBUTOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ETHAMBUTOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJETHAMBUTOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
TALCINACTIVE INGREDIENT7SEV7J4R1UETHAMBUTOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETHAMBUTOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
ETHAMBUTOL HYDROCHLORIDEACTIVE INGREDIENTQE4VW5FO07ETHAMBUTOL HYDROCHLORIDE (ETHAMBUTOL HYDROCHLORIDE) TABLET [LUPIN PHARMACEUTICALS INC]1
ETHAMBUTOLACTIVE MOIETY8G167061QZETHAMBUTOL HYDROCHLORIDE (ETHAMBUTOL HYDROCHLORIDE) TABLET [LUPIN PHARMACEUTICALS INC]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ETHAMBUTOL HYDROCHLORIDE (ETHAMBUTOL HYDROCHLORIDE) TABLET [LUPIN PHARMACEUTICALS INC]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BETHAMBUTOL HYDROCHLORIDE (ETHAMBUTOL HYDROCHLORIDE) TABLET [LUPIN PHARMACEUTICALS INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOETHAMBUTOL HYDROCHLORIDE (ETHAMBUTOL HYDROCHLORIDE) TABLET [LUPIN PHARMACEUTICALS INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ETHAMBUTOL HYDROCHLORIDE (ETHAMBUTOL HYDROCHLORIDE) TABLET [LUPIN PHARMACEUTICALS INC]1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95ETHAMBUTOL HYDROCHLORIDE (ETHAMBUTOL HYDROCHLORIDE) TABLET [LUPIN PHARMACEUTICALS INC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EETHAMBUTOL HYDROCHLORIDE (ETHAMBUTOL HYDROCHLORIDE) TABLET [LUPIN PHARMACEUTICALS INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ETHAMBUTOL HYDROCHLORIDE (ETHAMBUTOL HYDROCHLORIDE) TABLET [LUPIN PHARMACEUTICALS INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJETHAMBUTOL HYDROCHLORIDE (ETHAMBUTOL HYDROCHLORIDE) TABLET [LUPIN PHARMACEUTICALS INC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UETHAMBUTOL HYDROCHLORIDE (ETHAMBUTOL HYDROCHLORIDE) TABLET [LUPIN PHARMACEUTICALS INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETHAMBUTOL HYDROCHLORIDE (ETHAMBUTOL HYDROCHLORIDE) TABLET [LUPIN PHARMACEUTICALS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-281ETHAMBUTOL HYDROCHLORIDE TABLET [LUPIN PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 3 package rows20250309_c732b415-e1f9-478f-896d-1dc8b6362da4.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
995599ethambutol HCl 100 MG Oral TabletPSNc732b415-e1f9-478f-896d-1dc8b6362da411
995607ethambutol HCl 400 MG Oral TabletPSNc732b415-e1f9-478f-896d-1dc8b6362da411
995599ethambutol hydrochloride 100 MG Oral TabletSCDc732b415-e1f9-478f-896d-1dc8b6362da411
995607ethambutol hydrochloride 400 MG Oral TabletSCDc732b415-e1f9-478f-896d-1dc8b6362da411
995607ethambutol HCl 400 MG Oral TabletPSNd32e9865-8edd-4644-9939-62ed119db3ef7
995607ethambutol hydrochloride 400 MG Oral TabletSCDd32e9865-8edd-4644-9939-62ed119db3ef7
995607ethambutol HCl 400 MG Oral TabletPSN8ee30365-adc1-4b93-b263-9f8b79223b023
995607ethambutol hydrochloride 400 MG Oral TabletSCD8ee30365-adc1-4b93-b263-9f8b79223b023

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-281-0168180028101100 TABLET in 1 BOTTLE (68180-281-01) 100 tablet2009-07-040000-00-00NoNoCurrent
68180-281-0268180028102500 TABLET in 1 BOTTLE (68180-281-02) 500 tablet2009-07-040000-00-00NoNoCurrent
68180-281-116818002811114 in 1 BLISTER PACKHistorical
68180-281-13681800281134 BLISTER PACK in 1 CARTON (68180-281-13) > 14 TABLET in 1 BLISTER PACK (68180-281-11) 4 blister pack2009-07-040000-00-00NoNoCurrent