KETAMINE HYDROCHLORIDE

Product NDC: 0404-9759
11-digit product format: 004049759
Labeler code: 0404
Product ID: 0404-9759_a68d5a53-dda2-453a-bf13-b8e7c821a012
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ketamine hydrochloride
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Henry Schein, Inc.
Application: ANDA215808
Marketing category: ANDA
Marketing start: 2026-09-08
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: 2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A215808-001	KETAMINE HYDROCHLORIDE	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-13
A215808-002	KETAMINE HYDROCHLORIDE	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-13
A215808-003	KETAMINE HYDROCHLORIDE	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2025-04-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A215808-001	AP
A215808-002	AP
A215808-003	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 2 · 56 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
2026-09-14 22:38:34	2026-08	A215808-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215808-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215808-003	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2025-04-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215808-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215808-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215808-003	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2025-04-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215808-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215808-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215808-003	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2025-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215808-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215808-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215808-003	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2025-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215808-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215808-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215808-003	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	2025-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215808-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215808-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215808-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215808-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215808-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215808-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215808-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215808-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215808-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2023-01-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215808-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		2023-01-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215808-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215808-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215808-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215808-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	2023-01-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215808-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2023-01-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215808-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		2023-01-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215808-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2023-01-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215808-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		2023-01-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215808-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2023-01-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215808-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		2023-01-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215808-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2023-01-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215808-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		2023-01-13	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215808-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2023-01-13	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215808-002	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		2023-01-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215808-001	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2023-01-13	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A215808-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215808-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215808-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215808-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215808-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215808-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215808-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215808-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215808-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215808-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215808-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215808-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215808-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215808-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215808-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215808-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215808-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215808-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215808-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215808-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215808-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215808-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215808-002	AP	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215808-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215808-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215808-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215808-002	AP	1	`d06236e962d9…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215808-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215808-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215808-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215808-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215808-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A215808-002	AP	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215808-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215808-002	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215808-003	AP	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
238083	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
76d6aad3-0515-49da-a6e1-3fe2a1938a24	Available on FDA.report

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.	76d6aad3-0515-49da-a6e1-3fe2a1938a24	2026-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215808 application number: ANDA215808 ndc (product): 0404-9759
ketamine hydrochloride	KETAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ac2e715d-251c-4e3f-b91c-972f466d0beb	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215808 application number: ANDA215808
ketamine hydrochloride	KETAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	cc67b0fd-ca73-49f6-b5ca-705dc7331776	2025-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215808 application number: ANDA215808

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	Units	Marketing start	Sample	Exclude flag	Status
0404-9759-05	00404975905	1 VIAL in 1 BAG (0404-9759-05) / 5 mL in 1 VIAL	1 vial	2026-09-08	No	No	Current