NDC 68850-010

Myambutol

Ethambutol Hydrochloride

Myambutol is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sti Pharma, Llc. The primary component is Ethambutol Hydrochloride.

Product ID68850-010_1af4db6d-a908-49f8-b2aa-dc73796d03af
NDC68850-010
Product TypeHuman Prescription Drug
Proprietary NameMyambutol
Generic NameEthambutol Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-08-10
Marketing CategoryNDA / NDA
Application NumberNDA016320
Labeler NameSTI Pharma, LLC
Substance NameETHAMBUTOL HYDROCHLORIDE
Active Ingredient Strength100 mg/1
Pharm ClassesAntimycobacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68850-010-01

100 TABLET, FILM COATED in 1 BOTTLE (68850-010-01)
Marketing Start Date2007-08-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68850-010-01 [68850001001]

Myambutol TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA016320
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-08-10
Inactivation Date2020-01-31
Reactivation Date2020-03-03

Drug Details

Active Ingredients

IngredientStrength
ETHAMBUTOL HYDROCHLORIDE100 mg/1

OpenFDA Data

SPL SET ID:b362b3cd-2c26-4af5-baa4-084217729fa5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 995599
  • 995609
  • 995605
  • 995607
  • UPC Code
  • 0368850012025
  • Pharmacological Class

    • Antimycobacterial [EPC]

    NDC Crossover Matching brand name "Myambutol" or generic name "Ethambutol Hydrochloride"

    NDCBrand NameGeneric Name
    50090-0417MyambutolEthambutol hydrochloride
    50090-2607MyambutolEthambutol hydrochloride
    68850-010MyambutolEthambutol hydrochloride
    68850-012MyambutolMyambutol
    70518-2691MyambutolMyambutol
    0555-0923Ethambutol HydrochlorideEthambutol Hydrochloride
    42806-101ETHAMBUTOL HYDROCHLORIDEETHAMBUTOL HYDROCHLORIDE
    42806-102ETHAMBUTOL HYDROCHLORIDEETHAMBUTOL HYDROCHLORIDE
    50090-2337Ethambutol HydrochlorideEthambutol Hydrochloride
    50090-2399Ethambutol HydrochlorideEthambutol Hydrochloride
    50090-3948Ethambutol HydrochlorideEthambutol Hydrochloride
    50090-5140Ethambutol HydrochlorideEthambutol Hydrochloride
    50090-5142Ethambutol HydrochlorideEthambutol Hydrochloride
    53808-0977Ethambutol HydrochlorideETHAMBUTOL HYDROCHLORIDE
    54879-001Ethambutol HydrochlorideEthambutol Hydrochloride
    54879-002Ethambutol HydrochlorideEthambutol Hydrochloride
    55695-023Ethambutol HydrochlorideEthambutol Hydrochloride
    55695-035Ethambutol HydrochlorideEthambutol Hydrochloride
    61748-011Ethambutol HydrochlorideEthambutol Hydrochloride
    61748-014Ethambutol HydrochlorideEthambutol Hydrochloride
    68084-280Ethambutol HydrochlorideEthambutol Hydrochloride
    68151-0149Ethambutol HydrochlorideEthambutol Hydrochloride
    68180-280Ethambutol HydrochlorideEthambutol Hydrochloride
    68180-281Ethambutol HydrochlorideEthambutol Hydrochloride
    68850-004Ethambutol HydrochlorideEthambutol Hydrochloride
    68850-005Ethambutol HydrochlorideEthambutol Hydrochloride

    Trademark Results [Myambutol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MYAMBUTOL
    MYAMBUTOL
    72142913 0742904 Dead/Cancelled
    American Cyanamid Company
    1962-04-24

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.