Home NDC 55150-438 KETAMINE HYDROCHLORIDE
Product NDC 55150-438
11-digit product format 551500438
Labeler code 55150
Product ID 55150-438_a52dc360-8700-489c-b7c6-f5c278a6c1b7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name KETAMINE HYDROCHLORIDE
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Eugia US LLC
Application ANDA076092
Marketing category ANDA
Marketing start 2021-03-15
Substance KETAMINE HYDROCHLORIDE
Active strength 10 mg/mL
Pharmacologic classes General Anesthesia [PE], General Anesthetic [EPC]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base KETAMINE HYDROCHLORIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength KETAMINE HYDROCHLORIDE 10 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55150-438-10 KETAMINE HYDROCHLORIDE 20 mL in 1 VIAL, MULTI-DOSE INJECTION 20 6 55150-438-10 KETAMINE HYDROCHLORIDE 10 in 1 CARTON INJECTION 10 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-438 KETAMINE HYDROCHLORIDE INJECTION [EUGIA US LLC] 3 Current NDC, Legacy NDC, 2 package rows 20240207_f8b01c77-620d-4734-a771-b8524b65bcca.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55150-438-10 55150043810 10 VIAL, MULTI-DOSE in 1 CARTON (55150-438-10) / 20 mL in 1 VIAL, MULTI-DOSE 2021-03-15 0000-00-00 No No Current