KETALAR

Product NDC: 0404-9880
11-digit product format: 004049880
Labeler code: 0404
Product ID: 0404-9880_66dc4477-9189-4ff8-b778-8ceb17a50802
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ketamine hydrochloride
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Henry Schein, Inc
Application: NDA016812
Marketing category: NDA
Marketing start: 2022-01-11
Substance: KETAMINE HYDROCHLORIDE
Active strength: 10 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 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	RLD / RS
N016812-001	KETALAR	KETAMINE HYDROCHLORIDE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N016812-002	KETALAR	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982
N016812-003	KETALAR	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N016812-001	AP
N016812-002	AP
N016812-003	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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N016812-001	KETALAR	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016812-002	KETALAR	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016812-003	KETALAR	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016812-001	KETALAR	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016812-002	KETALAR	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016812-003	KETALAR	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016812-001	KETALAR	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016812-002	KETALAR	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016812-003	KETALAR	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016812-001	KETALAR	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016812-002	KETALAR	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016812-003	KETALAR	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016812-001	KETALAR	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016812-002	KETALAR	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016812-003	KETALAR	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016812-001	KETALAR	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016812-002	KETALAR	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016812-003	KETALAR	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016812-001	KETALAR	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016812-002	KETALAR	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016812-003	KETALAR	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016812-001	KETALAR	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016812-002	KETALAR	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016812-003	KETALAR	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016812-001	KETALAR	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016812-002	KETALAR	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016812-003	KETALAR	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016812-001	KETALAR	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016812-002	KETALAR	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016812-003	KETALAR	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016812-001	KETALAR	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016812-002	KETALAR	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016812-003	KETALAR	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016812-001	KETALAR	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016812-002	KETALAR	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016812-003	KETALAR	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016812-001	KETALAR	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016812-002	KETALAR	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016812-003	KETALAR	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016812-001	KETALAR	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N016812-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016812-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016812-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016812-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016812-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016812-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016812-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016812-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016812-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016812-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016812-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016812-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016812-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016812-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016812-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016812-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016812-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016812-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016812-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016812-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016812-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016812-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016812-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016812-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016812-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016812-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016812-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016812-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016812-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016812-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016812-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016812-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016812-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016812-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016812-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016812-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016812-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016812-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016812-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016812-001	AP	1	`301d65b070ca…`

Additional Listing Data#

Finished product: Yes
Brand name base: KETALAR
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
KETAMINE HYDROCHLORIDE	10 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
206967	Internal RxNorm lookup
238082	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
46dab560-8ecd-4d92-8c92-6baa2310b09b	Available on FDA.report

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
0404-9880-20	KETALAR	20 mL in 1 VIAL	INJECTION	20		5
0404-9880-20	KETALAR	1 in 1 BAG	INJECTION	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9880	KETALAR (KETAMINE HYDROCHLORIDE) INJECTION [HENRY SCHEIN, INC]	5	Current NDC, Legacy NDC, 2 package rows	20250129_46dab560-8ecd-4d92-8c92-6baa2310b09b.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
Ketalar	KETAMINE HYDROCHLORIDE	Par Health USA, LLC	14e8f864-8b8a-4e7e-8439-e510d3107063	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016812 application number: NDA016812
KETALAR	KETAMINE HYDROCHLORIDE	Henry Schein, Inc	46dab560-8ecd-4d92-8c92-6baa2310b09b	2025-01-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016812 application number: NDA016812 ndc (product): 0404-9880

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
206967	Ketalar 10 MG/ML Injectable Solution	PSN	46dab560-8ecd-4d92-8c92-6baa2310b09b	5
238082	ketamine 10 MG/ML Injectable Solution	PSN	46dab560-8ecd-4d92-8c92-6baa2310b09b	5
206967	ketamine 10 MG/ML Injectable Solution [Ketalar]	SBD	46dab560-8ecd-4d92-8c92-6baa2310b09b	5
238082	ketamine 10 MG/ML Injectable Solution	SCD	46dab560-8ecd-4d92-8c92-6baa2310b09b	5
206967	Ketalar (ketamine hydrochloride) 10 MG/ML Injectable Solution	SY	46dab560-8ecd-4d92-8c92-6baa2310b09b	5
238082	ketamine (as ketamine hydrochloride) 10 MG/ML Injectable Solution	SY	46dab560-8ecd-4d92-8c92-6baa2310b09b	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-9880-20	00404988020	1 VIAL in 1 BAG (0404-9880-20) / 20 mL in 1 VIAL	1 vial	2022-01-11	0000-00-00	No	No	Current