FDA Orange Book · active-ingredient family
Benzonatate
Benzonatate: 1 brand, 14 generics; first approved Jan 29, 1993; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 14 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
14
Listed patents
0
Presentations
34
Brand (NDA) products
Originator applications
- TESSALONRLDPFIZERNDA 011210—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AA 200MG CAPSULE ORAL Discontinued —
Generic (ANDA) products (14)
Abbreviated applications
- BENZONATATEMARKSANS PHARMAANDA 22029820262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AA 200MG CAPSULE ORAL Rx AA - BENZONATATEASCENT PHARMS INCANDA 21151820193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AA 150MG CAPSULE ORAL Rx AA 200MG CAPSULE ORAL Rx AA - BENZONATATERSPURACAP PHARM LLCANDA 20694820182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AA 200MG CAPSULE ORAL Rx AA - BENZONATATECHARTWELL RXANDA 21056220183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — 150MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — - BENZONATATECSPC-NBP PHARMANDA 20276520172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE ORAL Rx AA 100MG CAPSULE ORAL Rx AA - BENZONATATEONESOURCE SPECIALTYANDA 09113320152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AA 200MG CAPSULE ORAL Rx AA - BENZONATATEACELLAANDA 09131020152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — - BENZONATATEMIKARTANDA 04085120093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — 150MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — - BENZONATATESUN PHARM INDS INCANDA 04058720082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — - BENZONATATENESHER PHARMSANDA 04079520072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — - BENZONATATEHERITAGE PHARMS LABSANDA 04068220072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AA 200MG CAPSULE ORAL Rx AA - BENZONATATEZYDUS PHARMS USAANDA 04059720072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AA 200MG CAPSULE ORAL Rx AA - BENZONATATETHEPHARMANETWORK LLCANDA 04062720073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AA 200MG CAPSULE ORAL Rx AA 150MG CAPSULE ORAL Rx AA - BENZONATATEBIONPHARMAANDA 08129719932 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AA 200MG CAPSULE ORAL Rx AA
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
34 yr 1 mo ago
Most recent approval
5 mo ago
Approvals span 1993–2026 across 15 FDA applications.
Brand (NDA) 17%
Generic (ANDA) 1493%
Benzonatate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
