ethambutol hydrochloride

Generic: ethambutol hydrochloride

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

ethambutol hydrochloride 400 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-281
Product ID 68180-281_b76b5b09-9d5d-4343-b128-0266024919b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078939
Listing Expiration 2026-12-31
Marketing Start 2009-07-04

Pharmacologic Class

Classes
antimycobacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180281
Hyphenated Format 68180-281

Supplemental Identifiers

RxCUI
995599 995607
UPC
0368180281016 0368180280019
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 ANDA078939 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68180-281-01)
source: ndc

Packages (1)

68180-281-01 100 TABLET in 1 BOTTLE (68180-281-01)

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": "b76b5b09-9d5d-4343-b128-0266024919b8", "openfda": {"upc": ["0368180281016", "0368180280019"], "unii": ["QE4VW5FO07"], "rxcui": ["995599", "995607"], "spl_set_id": ["c732b415-e1f9-478f-896d-1dc8b6362da4"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68180-281-01)", "package_ndc": "68180-281-01", "marketing_start_date": "20090704"}], "brand_name": "Ethambutol Hydrochloride", "product_id": "68180-281_b76b5b09-9d5d-4343-b128-0266024919b8", "dosage_form": "TABLET", "pharm_class": ["Antimycobacterial [EPC]"], "product_ndc": "68180-281", "generic_name": "Ethambutol Hydrochloride", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ethambutol Hydrochloride", "active_ingredients": [{"name": "ETHAMBUTOL HYDROCHLORIDE", "strength": "400 mg/1"}], "application_number": "ANDA078939", "marketing_category": "ANDA", "marketing_start_date": "20090704", "listing_expiration_date": "20261231"}