Ketamine Hydrochloride

Product NDC: 0409-0040
11-digit product format: 004090040
Labeler code: 0409
Product ID: 0409-0040_aa1e5788-73a9-4b95-99da-17eb252f8702
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: 2022-10-10
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

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	0409-0040		D	Discontinued by firm		2026-08-11
excluded package	package	0409-0040	0409-0040-10	D	Discontinued by firm		2026-08-11

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 82 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
2026-02-19 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…`
2021-12-28 21:50 UTC	2021-12	A074549-001	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	1996-06-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074549-002	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	1996-06-27	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074549-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074549-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074549-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074549-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074549-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074549-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074549-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074549-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074549-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074549-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074549-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074549-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074549-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074549-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074549-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074549-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074549-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074549-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074549-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074549-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074549-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074549-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074549-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074549-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074549-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074549-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074549-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074549-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074549-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074549-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074549-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074549-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074549-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074549-002	AP	1	`4b0b4de00fa7…`
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…`

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
0409-0040-05	Ketamine Hydrochloride	5 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION, CONCENTRATE	5		4
0409-0040-10	Ketamine Hydrochloride	10 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	10		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-0040-05	ML - Milliliter	0409-0040	236362eb-9d24-4048-a3be-defe49f06e77	1	2022-11-07
0409-0040-10	ML - Milliliter	0409-0040	388f5bbc-fc61-4c21-add1-969fa36c0a17	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-0040	KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20240521_390f2db8-0fcd-4648-b584-9effa084be27.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KETAMINE HYDROCHLORIDE	KETAMINE HYDROCHLORIDE	Henry Schein, Inc.	dd8eff00-b92e-4f48-8b57-0464484d6ddf	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074549 application number: ANDA074549
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-0040-05	00409004005	10 VIAL, MULTI-DOSE in 1 BOX (0409-0040-05) > 5 mL in 1 VIAL, MULTI-DOSE (0409-0040-10)	2022-10-10	0000-00-00	No	No	Current
0409-0040-10	00409004010	10 VIAL, MULTI-DOSE in 1 CARTON (0409-0040-10) / 5 mL in 1 VIAL, MULTI-DOSE (0409-0040-05)	2022-10-10	0000-00-00	No	No	Current