ethambutol hydrochloride

Generic: ethambutol hydrochloride

Labeler: epic pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

ethambutol hydrochloride 400 mg/1

Manufacturer
Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-102
Product ID 42806-102_a5247287-041a-4548-9a24-aadbfd233459
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075095
Listing Expiration 2026-12-31
Marketing Start 2015-03-18

Pharmacologic Class

Classes
antimycobacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42806102
Hyphenated Format 42806-102

Supplemental Identifiers

RxCUI
995599 995607
UPC
0342806101018 0342806102015
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 ANDA075095 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (42806-102-01)
source: ndc

Packages (1)

42806-102-01 100 TABLET, FILM COATED in 1 BOTTLE (42806-102-01)

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": "a5247287-041a-4548-9a24-aadbfd233459", "openfda": {"upc": ["0342806101018", "0342806102015"], "unii": ["QE4VW5FO07"], "rxcui": ["995599", "995607"], "spl_set_id": ["08decdf3-a397-42e7-8ac3-e489c0cc7085"], "manufacturer_name": ["Epic Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (42806-102-01)", "package_ndc": "42806-102-01", "marketing_start_date": "20200730"}], "brand_name": "ETHAMBUTOL HYDROCHLORIDE", "product_id": "42806-102_a5247287-041a-4548-9a24-aadbfd233459", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimycobacterial [EPC]"], "product_ndc": "42806-102", "generic_name": "ETHAMBUTOL HYDROCHLORIDE", "labeler_name": "Epic Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ETHAMBUTOL HYDROCHLORIDE", "active_ingredients": [{"name": "ETHAMBUTOL HYDROCHLORIDE", "strength": "400 mg/1"}], "application_number": "ANDA075095", "marketing_category": "ANDA", "marketing_start_date": "20150318", "listing_expiration_date": "20261231"}