Home NDC 55150-440 KETAMINE HYDROCHLORIDE
Product NDC 55150-440
11-digit product format 551500440
Labeler code 55150
Product ID 55150-440_35913e3d-e141-4596-bc4c-72deb8cbf932
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 100 mg/mL
Pharmacologic classes General Anesthesia [PE], General Anesthetic [EPC]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2026-12-31
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.
Additional Listing Data#
Finished product Yes
Brand name base KETAMINE HYDROCHLORIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength KETAMINE HYDROCHLORIDE 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O18YUO0I83 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 238082 Internal RxNorm lookup 238083 Internal RxNorm lookup 238084 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55150-440-10 KETAMINE HYDROCHLORIDE 10 in 1 CARTON INJECTION 10 6 55150-440-10 KETAMINE HYDROCHLORIDE 10 mL in 1 VIAL, MULTI-DOSE INJECTION 10 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-440 KETAMINE HYDROCHLORIDE INJECTION [EUGIA US LLC] 3 Current NDC, Legacy NDC, 2 package rows 20240207_f8b01c77-620d-4734-a771-b8524b65bcca.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 55150-440-10 55150044010 10 VIAL, MULTI-DOSE in 1 CARTON (55150-440-10) / 10 mL in 1 VIAL, MULTI-DOSE 2021-03-15 0000-00-00 No No Current