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Benzonatate 100 mg

Prescription ANDA TE AA
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Benzonatate 100 mg
Generic name
Benzonatate 100 mg
Dosage form
Capsule, Liquid Filled
Route
Oral
Marketing category
ANDA · ANDA
Labeler
MARKSANS PHARMA LIMITED
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
5
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Benzonatate 100 mg/1 197397 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule, Liquid Filled
Route of administration
Oral
Presentations
7

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Decreased Tracheobronchial Stretch Receptor Activity [PE] PE 4 members — no class page
Non-narcotic Antitussive [EPC] EPC 4 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
220298
Application type
ANDA · Abbreviated New Drug Application
Approval date
March 30, 2026
Sponsor
MARKSANS PHARMA
Products on application
2
Submissions recorded
1
Products approved under application 220298.
Product Trade name Form Strength Ingredient Status TE Flags
220298-001 BENZONATATE CAPSULE BENZONATATE Prescription AA
220298-002 BENZONATATE CAPSULE BENZONATATE Prescription AA

Therapeutic equivalence

Source: Orange Book
TE code
AA
Reference Listed Drug
No
Reference Standard
No

What this rating means: Therapeutically equivalent — no known or suspected bioequivalence problems (conventional dosage forms)

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 220298.
Type No. Action Status Date Review
Original application 1 Approved March 30, 2026 Standard

Adverse event reports

Source: openFDA FAERS
16,446
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: BENZONATATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
25000-002-03 25000-002 MARKSANS PHARMA LIMITED 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-002-03) April 10, 2026
25000-002-08 25000-002 MARKSANS PHARMA LIMITED 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-002-08) April 10, 2026
25000-002-12 25000-002 MARKSANS PHARMA LIMITED 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-002-12) April 10, 2026
49483-946-01 49483-946 TIME CAP LABORATORIES, INC 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-946-01) September 14, 2026
49483-946-50 49483-946 TIME CAP LABORATORIES, INC 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-946-50) September 14, 2026
25000-002 25000-002 MARKSANS PHARMA LIMITED — April 10, 2026
49483-946 49483-946 TIME CAP LABORATORIES, INC — September 14, 2026

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.