KETAMINE HYDROCHLORIDE | A074549 | HOSPIRA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from NRx Pharmaceuticals, Inc. FDA-2025-P-3577 · 5 docket documents NRx Pharmaceuticals, Inc. filed this citizen petition on August 29, 2025, requesting that the FDA ban all ketamine products containing benzethonium chloride, a preservative the petitioner asserts is toxic and not generally recognized as safe and effective. NRx argues that benzethonium chloride is un | 505(q) | 2025-09-05 | Open | NRx Pharmaceuticals, Inc. |
Attachment 2 KETALAR re Suitability Petition from Lachman Consulting Services... FDA-2023-P-4287 · 8 docket documents Lachman Consulting Services Inc filed a citizen petition regarding Ketalar (ketamine hydrochloride) requesting that the FDA determine the suitability of the drug substance and formulation for use in abbreviated new drug applications or generic drug development. | Suitability | 2023-10-03 | Granted | Lachman Consulting Services Inc |
Citizen Petition from Wildlife Labs, Inc. FDA-1999-P-2420 · 10 docket documents Wildlife Laboratories, Inc. filed a suitability petition requesting permission to submit an ANADA for Ketanil 200 (Ketamine Hydrochloride Injection) at a concentration of 200mg/ml, which differs from pioneer products by strength of the active ingredient only, and requested a waiver of in-vivo bioequ | Other | 2017-05-01 | Denied | Wildlife Labs, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.55
per ml
Lowest NADAC/Unit
$0.5397
per ml
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00409205105KETAMINE 500 MG/5 ML VIAL | $1.55 | ML | Generic | — | 2026-06-17 |
| 00409004010KETAMINE 500 MG/5 ML VIAL | $1.55 | ML | Generic | — | 2026-06-17 |
| 00409205310KETAMINE 500 MG/10 ML VIAL | $0.5397 | ML | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.