Home NDC 0409-2051 Ketamine Hydrochloride
Product NDC 0409-2051
11-digit product format 004092051
Labeler code 0409
Product ID 0409-2051_37921fa5-8ef5-4af7-bf99-3a9ab24fa752
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ketamine Hydrochloride
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA074549
Marketing category ANDA
Marketing start 2004-11-30
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 42 .
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 A074549-001 KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 A074549-002 KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27
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 · 84 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 2026-08-18 06:07:40 2026-07 A074549-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074549-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074549-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074549-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074549-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074549-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074549-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074549-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074549-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074549-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074549-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074549-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074549-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074549-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074549-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074549-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074549-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074549-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074549-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074549-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074549-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074549-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074549-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074549-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074549-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074549-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074549-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074549-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074549-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074549-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074549-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074549-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074549-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074549-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074549-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074549-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074549-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074549-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074549-001 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074549-002 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 1996-06-27 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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 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 · 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 0409-2051-05 Ketamine Hydrochloride 10 in 1 BOX INJECTION, SOLUTION, CONCENTRATE 10 19 0409-2051-15 Ketamine Hydrochloride 5 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION, CONCENTRATE 5 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded KETAMINE HYDROCHLORIDE ACTIVE INGREDIENT O18YUO0I83 KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] 3 KETAMINE ACTIVE MOIETY 690G0D6V8H KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] 3 BENZETHONIUM CHLORIDE INACTIVE INGREDIENT PH41D05744 KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] 3 KETAMINE HYDROCHLORIDE ACTIVE INGREDIENT O18YUO0I83 KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [GENERAL INJECTABLES & VACCINES, INC] 1 KETAMINE ACTIVE MOIETY 690G0D6V8H KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [GENERAL INJECTABLES & VACCINES, INC] 1 BENZETHONIUM CHLORIDE INACTIVE INGREDIENT PH41D05744 KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [GENERAL INJECTABLES & VACCINES, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-2051 KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] 19 Current NDC, Legacy NDC, 2 package rows 20240717_bb912318-2e22-4469-b0a2-774803ee1bb8.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 0409-2051-05 00409205105 10 VIAL, MULTI-DOSE in 1 BOX (0409-2051-05) / 5 mL in 1 VIAL, MULTI-DOSE (0409-2051-15) 2004-11-30 0000-00-00 No No Current 0409-2051-15 00409205115 5 mL in 1 VIAL, MULTI-DOSE 5 ml Historical