ethambutol hydrochloride

Generic: ethambutol hydrochloride

Labeler: marlex pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ethambutol hydrochloride
Generic Name ethambutol hydrochloride
Labeler marlex pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ethambutol hydrochloride 400 mg/1

Manufacturer
Marlex Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 10135-797
Product ID 10135-797_2dcb6b41-b9a8-4dde-8248-334d13f87a29
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA016320
Listing Expiration 2026-12-31
Marketing Start 2006-12-15

Pharmacologic Class

Classes
antimycobacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10135797
Hyphenated Format 10135-797

Supplemental Identifiers

RxCUI
995599 995607
UNII
QE4VW5FO07

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ethambutol hydrochloride (source: ndc)
Generic Name ethambutol hydrochloride (source: ndc)
Application Number NDA016320 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (10135-797-01)
source: ndc

Packages (1)

10135-797-01 100 TABLET, FILM COATED in 1 BOTTLE (10135-797-01)

Ingredients (1)

ethambutol hydrochloride (400 mg/1)

Linked Drug Pages (1)

ETHAMBUTOL HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2dcb6b41-b9a8-4dde-8248-334d13f87a29", "openfda": {"unii": ["QE4VW5FO07"], "rxcui": ["995599", "995607"], "spl_set_id": ["1b9fbe16-edfc-44b6-b8d8-5c5a9d7558e1"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (10135-797-01)", "package_ndc": "10135-797-01", "marketing_start_date": "20250826"}], "brand_name": "ETHAMBUTOL HYDROCHLORIDE", "product_id": "10135-797_2dcb6b41-b9a8-4dde-8248-334d13f87a29", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimycobacterial [EPC]"], "product_ndc": "10135-797", "generic_name": "ETHAMBUTOL HYDROCHLORIDE", "labeler_name": "Marlex Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ETHAMBUTOL HYDROCHLORIDE", "active_ingredients": [{"name": "ETHAMBUTOL HYDROCHLORIDE", "strength": "400 mg/1"}], "application_number": "NDA016320", "marketing_category": "NDA", "marketing_start_date": "20061215", "listing_expiration_date": "20261231"}