Home NDC 0143-9508 Ketamine Hydrochloride
Product NDC 0143-9508
11-digit product format 001439508
Labeler code 0143
Product ID 0143-9508_6ada9356-0968-46df-b067-d95509650c48
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ketamine Hydrochloride
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA074524
Marketing category ANDA
Marketing start 1996-07-01
Substance KETAMINE HYDROCHLORIDE
Active strength 50 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074524-001 KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 A074524-002 KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 86 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 A074524-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074524-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074524-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074524-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074524-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074524-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074524-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074524-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074524-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074524-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074524-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074524-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074524-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074524-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074524-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074524-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074524-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074524-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074524-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074524-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074524-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074524-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074524-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074524-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP RS 1996-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074524-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-03-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074524-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074524-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-03-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074524-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-03-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074524-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-03-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074524-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-03-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074524-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-03-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074524-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-03-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074524-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-03-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074524-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-03-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074524-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-03-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074524-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-03-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074524-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-03-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074524-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-03-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074524-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-03-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074524-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-03-22 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 50 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 0143-9508-01 Ketamine Hydrochloride 10 mL in 1 VIAL INJECTION 10 8 0143-9508-10 Ketamine Hydrochloride 10 in 1 BOX INJECTION 10 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9508 KETAMINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 8 Current NDC, Legacy NDC, 2 package rows 20240228_58487c78-a641-4278-acc0-343596ee8683.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0143-9508-01 00143950801 10 mL in 1 VIAL 10 ml Historical 0143-9508-10 00143950810 10 VIAL in 1 BOX (0143-9508-10) / 10 mL in 1 VIAL (0143-9508-01) 10 vial 1996-07-01 0000-00-00 No No Current