FDA Orange Book · active-ingredient family
Ketamine hydrochloride
Ketamine hydrochloride: 1 brand, 7 generics; first approved Mar 22, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 7 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
7
Listed patents
0
Presentations
19
Brand (NDA) products
Originator applications
- PH HEALTHNDA 016812—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/ML INJECTABLE INJECTION Rx AP EQ 50MG BASE/ML INJECTABLE INJECTION Rx AP EQ 100MG BASE/ML INJECTABLE INJECTION Rx AP
Generic (ANDA) products (7)
Abbreviated applications
- KETAMINE HYDROCHLORIDERSBAXTER HLTHCARE CORPANDA 21968420262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/10ML (EQ 10MG BASE/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 50MG BASE/5ML (EQ 10MG BASE/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Rx — - KETAMINE HYDROCHLORIDECAPLINANDA 2178582025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/ML INJECTABLE INJECTION Discontinued — - KETAMINE HYDROCHLORIDEGLANDANDA 21680920233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/ML INJECTABLE INJECTION Rx AP EQ 50MG BASE/ML INJECTABLE INJECTION Rx AP EQ 100MG BASE/ML INJECTABLE INJECTION Rx AP - KETAMINE HYDROCHLORIDEFRESENIUS KABI USAANDA 21580820233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/ML INJECTABLE INJECTION Rx AP EQ 50MG BASE/ML INJECTABLE INJECTION Rx AP EQ 100MG BASE/ML INJECTABLE INJECTION Rx AP - KETAMINE HYDROCHLORIDEEUGIA PHARMAANDA 07609220083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/ML INJECTABLE INJECTION Rx AP EQ 50MG BASE/ML INJECTABLE INJECTION Rx AP EQ 100MG BASE/ML INJECTABLE INJECTION Rx AP - KETAMINE HYDROCHLORIDEHOSPIRAANDA 07454919962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/ML INJECTABLE INJECTION Rx AP EQ 100MG BASE/ML INJECTABLE INJECTION Rx AP - KETAMINE HYDROCHLORIDERSHIKMAANDA 07452419962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/ML INJECTABLE INJECTION Rx AP EQ 100MG BASE/ML INJECTABLE INJECTION Rx AP
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
30 yr 11 mo ago
Most recent approval
1 mo ago
Approvals span 1996–2026 across 8 FDA applications.
Brand (NDA) 113%
Generic (ANDA) 788%
Ketamine hydrochloride: 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.
