FDA Orange Book · active-ingredient family
Acetohexamide
Acetohexamide: 1 brand, 5 generics; first approved Nov 03, 1986; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 5 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
5
Listed patents
0
Presentations
8
Brand (NDA) products
Originator applications
- LILLYNDA 013378—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 250MG TABLET ORAL Discontinued —
Generic (ANDA) products (5)
Abbreviated applications
- ACETOHEXAMIDEWATSON LABS TEVAANDA 0718931987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - ACETOHEXAMIDEWATSON LABS TEVAANDA 0718941987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — - ACETOHEXAMIDEANI PHARMSANDA 07087019872 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 250MG TABLET ORAL Discontinued — - ACETOHEXAMIDEUSL PHARMAANDA 0707531986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - ACETOHEXAMIDEUSL PHARMAANDA 0707541986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued —
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
40 yr 4 mo ago
Most recent approval
39 yr 3 mo ago
Approvals span 1986–1987 across 6 FDA applications.
Brand (NDA) 117%
Generic (ANDA) 583%
Acetohexamide: 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.
