ethambutol hydrochloride

Generic: ethambutol hydrochloride

Labeler: sti pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name ethambutol hydrochloride
Generic Name ethambutol hydrochloride
Labeler sti pharma llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ethambutol hydrochloride 400 mg/1

Manufacturer
STI Pharma LLC

Identifiers & Regulatory

Product NDC 54879-002
Product ID 54879-002_0ec564dd-5593-52ee-e063-6294a90a34de
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
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 54879002
Hyphenated Format 54879-002

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
  • 12 CARTON in 1 BOX (54879-002-01) / 12 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

54879-002-01 12 CARTON in 1 BOX (54879-002-01) / 12 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE

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": "0ec564dd-5593-52ee-e063-6294a90a34de", "openfda": {"unii": ["QE4VW5FO07"], "rxcui": ["995599", "995607"], "spl_set_id": ["3f6428d6-3745-4337-ad78-ebfff9f49135"], "manufacturer_name": ["STI Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 CARTON in 1 BOX (54879-002-01)  / 12 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "54879-002-01", "marketing_start_date": "20061215"}], "brand_name": "Ethambutol Hydrochloride", "product_id": "54879-002_0ec564dd-5593-52ee-e063-6294a90a34de", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimycobacterial [EPC]"], "product_ndc": "54879-002", "generic_name": "Ethambutol Hydrochloride", "labeler_name": "STI Pharma LLC", "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 AUTHORIZED GENERIC", "marketing_start_date": "20061215", "listing_expiration_date": "20261231"}