KETAMINE HYDROCHLORIDE

Product NDC: 0404-9882
11-digit product format: 004049882
Labeler code: 0404
Product ID: 0404-9882_055b8c79-46c8-4d31-b6fb-47ebb5c5bd4e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ketamine hydrochloride
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Henry Schein, Inc.
Application: ANDA074549
Marketing category: ANDA
Marketing start: 2022-01-11
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0404-9882		D	Discontinued by firm		2026-10-16
excluded package	package	0404-9882	0404-9882-10	D	Discontinued by firm		2026-10-16

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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.

Application-product, TE code table
Application-product	TE code
A074549-001	AP
A074549-002	AP

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A074549-001	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	1996-06-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A074549-002	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	1996-06-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A074549-001	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	1996-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074549-002	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	1996-06-27	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074549-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074549-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074549-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074549-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074549-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074549-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074549-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074549-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074549-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074549-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074549-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074549-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074549-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074549-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074549-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074549-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074549-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074549-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074549-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074549-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074549-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074549-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074549-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A074549-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074549-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A074549-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074549-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074549-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074549-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074549-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074549-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074549-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074549-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074549-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074549-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A074549-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074549-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A074549-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074549-001	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074549-002	AP	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bb4bf50b-0475-bcb2-86ff-7b0cc2cc55bc	Product name	2	20240223

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0404-9882-10	KETAMINE HYDROCHLORIDE	10 mL in 1 VIAL	INJECTION, SOLUTION, CONCENTRATE	10		5
0404-9882-10	KETAMINE HYDROCHLORIDE	1 in 1 BAG	INJECTION, SOLUTION, CONCENTRATE	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9882	KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HENRY SCHEIN, INC.]	4	Legacy NDC, 2 package rows	20241016_dd8eff00-b92e-4f48-8b57-0464484d6ddf.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketamine Hydrochloride	KETAMINE HYDROCHLORIDE	Hospira, Inc.	bb912318-2e22-4469-b0a2-774803ee1bb8	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074549 application number: ANDA074549
Ketamine Hydrochloride	KETAMINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	ea600f8a-857f-4e0e-e053-2995a90a017d	2023-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074549 application number: ANDA074549

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O18YUO0I83	KETAMINE HYDROCHLORIDE	1867-66-9	KETAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
238084	ketamine 50 MG/ML Injectable Solution	PSN	dd8eff00-b92e-4f48-8b57-0464484d6ddf	5
238084	ketamine 50 MG/ML Injectable Solution	SCD	dd8eff00-b92e-4f48-8b57-0464484d6ddf	5
238084	ketamine (as ketamine hydrochloride) 50 MG/ML Injectable Solution	SY	dd8eff00-b92e-4f48-8b57-0464484d6ddf	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-9882-10	00404988210	1 VIAL in 1 BAG (0404-9882-10) > 10 mL in 1 VIAL	1 vial	2022-01-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketamine Hydrochloride Injection, USP Rx only CIII	Henry Schein, Inc.	2026-07-30	HUMAN PRESCRIPTION DRUG LABEL	6