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Active ingredient

Benzonatate

140 finished FDA listings contain Benzonatate as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
BENZONATATE
Dosage forms
Capsule, Capsule, Liquid Filled
Routes
Oral
Manufacturers / labelers
45
Strengths listed
100 mg/1 · 150 mg/1 · 200 mg/1
Brand names in FDA listings
Benzonatate 100 Mg, Benzonatate 200 Mg

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 18993

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 081297BIONPHARMA1993-01-2912
ANDA 040627THEPHARMANETWORK LLC2007-03-309
ANDA 040597ZYDUS PHARMS USA2007-06-0815
ANDA 040749THEPHARMANETWORK LLC2007-07-253
ANDA 040682HERITAGE PHARMS LABS2007-07-3011
ANDA 091133ONESOURCE SPECIALTY2015-07-306
ANDA 202765CSPC-NBP PHARM2015-07-3127
ANDA 206948PURACAP PHARM LLC2018-12-1932
ANDA 211518ASCENT PHARMS INC2019-02-2221
ANDA 220298PHARMAZONE2026-03-304

Official labeling on DailyMed

Showing the 12 most recent of 106 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.