Home NDC 52584-108 KETAMINE HYDROCHLORIDE
Product NDC 52584-108
11-digit product format 525840108
Labeler code 52584
Product ID 52584-108_db6963dc-47d4-478b-a3c1-84f9b39b8d6d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ketamine hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler General Injectables and Vaccines, Inc.
Application ANDA076092
Marketing category ANDA
Marketing start 2018-02-28
Marketing end 0000-00-00
Substance KETAMINE HYDROCHLORIDE
Active strength 100 mg/mL
Pharmacologic classes General Anesthesia [PE],General Anesthetic [EPC]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 52584-108-00 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 52584-108-00 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 52584-108-00 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 52584-108-00 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 52584-108-00 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 52584-108-00 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 52584-108-00 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 52584-108-00 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 52584-108-00 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 52584-108-00 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 52584-108-00 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 52584-108-00 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 52584-108-00 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 52584-108-00 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 52584-108-00 I Inactivated by FDA bd6a592717d7…303034d00443…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076092-001 KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 A076092-002 KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 A076092-003 KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076092-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2001-12-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076092-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2002-10-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076092-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2008-09-30 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 52584-108-00 52584010800 1 VIAL, MULTI-DOSE in 1 BAG (52584-108-00) > 10 mL in 1 VIAL, MULTI-DOSE 2018-02-28 0000-00-00 No No Current