FDA.reportPublic FDA data

Ethambutol Hydrochloride

Product NDC
54879-001
11-digit product format
548790001
Labeler code
54879
Product ID
54879-001_5115f4a9-63ad-ebc3-e063-6294a90a7ba8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ethambutol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
STI Pharma LLC
Application
NDA016320
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2006-12-15
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, 995607

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
e86e15b7-896a-6fb4-16e3-cf6efd994b64Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54879-001-01Ethambutol Hydrochloride12 in 1 CARTONTABLET, FILM COATED129
54879-001-01Ethambutol Hydrochloride12 in 1 BOXTABLET, FILM COATED129

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54879-001-00EA - Each54879-001325d667e-7318-44d7-a6a4-77c6b02753af12013-08-02
54879-001-01EA - Each54879-001fd3f1e6e-482d-4ec6-8d20-8c8e7af3023d12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ethambutol HydrochlorideACTIVE INGREDIENTQE4VW5FO07ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA LLC]1
EthambutolACTIVE MOIETY8G167061QZETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA LLC]1
GelatinINACTIVE INGREDIENT2G86QN327LETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA LLC]1
Hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA LLC]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA LLC]1
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA LLC]1
SorbitolINACTIVE INGREDIENT506T60A25RETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA LLC]1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA LLC]1
SucroseINACTIVE INGREDIENTC151H8M554ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA LLC]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54879-001ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA LLC]8Current NDC, Legacy NDC, 2 package rows20240113_3f6428d6-3745-4337-ad78-ebfff9f49135.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995599ethambutol HCl 100 MG Oral TabletPSN55a70cf5-c4b5-450e-9fc5-129077dfdfd621
995599ethambutol hydrochloride 100 MG Oral TabletSCD55a70cf5-c4b5-450e-9fc5-129077dfdfd621
995599ethambutol HCl 100 MG Oral TabletPSN3f6428d6-3745-4337-ad78-ebfff9f491359
995607ethambutol HCl 400 MG Oral TabletPSN3f6428d6-3745-4337-ad78-ebfff9f491359
995599ethambutol hydrochloride 100 MG Oral TabletSCD3f6428d6-3745-4337-ad78-ebfff9f491359
995607ethambutol hydrochloride 400 MG Oral TabletSCD3f6428d6-3745-4337-ad78-ebfff9f491359
995599ethambutol HCl 100 MG Oral TabletPSN2b867b73-de36-2bc2-e054-00144ff88e881
995607ethambutol HCl 400 MG Oral TabletPSN2b867b73-de36-2bc2-e054-00144ff88e881
995599ethambutol hydrochloride 100 MG Oral TabletSCD2b867b73-de36-2bc2-e054-00144ff88e881
995607ethambutol hydrochloride 400 MG Oral TabletSCD2b867b73-de36-2bc2-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54879-001-015487900010112 CARTON in 1 BOX (54879-001-01) > 12 BOTTLE in 1 CARTON > 100 TABLET, FILM COATED in 1 BOTTLE12 carton2006-12-150000-00-00NoNoCurrent