Application 074549

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KETAMINE HYDROCHLORIDE	KETAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 50MG BASE/ML	No	No
002	KETAMINE HYDROCHLORIDE	KETAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 100MG BASE/ML	No	No

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.

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 · 84 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
2026-08-18 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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074549-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074549-002	AP	1	`caaa826d4ba7…`
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…`

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 ndc (product): 0404-9882
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 ndc (product): 0409-2051 ndc (product): 0409-2053
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 ndc (product): 71872-7296

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9881	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9881	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9882	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9882	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	Henry Schein, Inc.	ANDA	Current
0409-0040	Ketamine Hydrochloride	KETAMINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-0040	Ketamine Hydrochloride	KETAMINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2051	Ketamine Hydrochloride	KETAMINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2051	Ketamine Hydrochloride	KETAMINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2051	Ketamine Hydrochloride	Ketamine Hydrochloride	Hospira, Inc.	ANDA	Current
0409-2051	Ketamine Hydrochloride	KETAMINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2051	Ketamine Hydrochloride	KETAMINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2051	Ketamine Hydrochloride	Ketamine Hydrochloride	Hospira, Inc.	ANDA	Current
0409-2051	Ketamine Hydrochloride	Ketamine Hydrochloride	Hospira, Inc.	ANDA	Current
0409-2051	Ketamine Hydrochloride	KETAMINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2051	Ketamine Hydrochloride	KETAMINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2051	Ketamine Hydrochloride	Ketamine Hydrochloride	Hospira, Inc.	ANDA	Current
0409-2051	Ketamine Hydrochloride	Ketamine Hydrochloride	Hospira, Inc.	ANDA	Current
0409-2053	Ketamine Hydrochloride	KETAMINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2053	Ketamine Hydrochloride	KETAMINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2053	Ketamine Hydrochloride	Ketamine Hydrochloride	Hospira, Inc.	ANDA	Current
0409-2053	Ketamine Hydrochloride	KETAMINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2053	Ketamine Hydrochloride	KETAMINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2053	Ketamine Hydrochloride	Ketamine Hydrochloride	Hospira, Inc.	ANDA	Current
0409-2053	Ketamine Hydrochloride	Ketamine Hydrochloride	Hospira, Inc.	ANDA	Current
0409-2053	Ketamine Hydrochloride	KETAMINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2053	Ketamine Hydrochloride	KETAMINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2053	Ketamine Hydrochloride	Ketamine Hydrochloride	Hospira, Inc.	ANDA	Current
0409-2053	Ketamine Hydrochloride	Ketamine Hydrochloride	Hospira, Inc.	ANDA	Current
52584-038	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-038	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-038	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-040	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-040	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-040	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-040	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-040	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-040	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-040	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
71872-7296	Ketamine Hydrochloride	Ketamine Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current