Application 011559

Type: NDA
Sponsor: PAR STERILE PRODUCTS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BREVITAL SODIUM	METHOHEXITAL SODIUM	INJECTABLE;INJECTION	500MG/VIAL	Yes	Yes
002	BREVITAL SODIUM	METHOHEXITAL SODIUM	INJECTABLE;INJECTION	2.5GM/VIAL	Yes	Yes
003	BREVITAL SODIUM	METHOHEXITAL SODIUM	INJECTABLE;INJECTION	5GM/VIAL	No	No
004	BREVITAL SODIUM	METHOHEXITAL SODIUM	INJECTABLE;INJECTION	200MG/VIAL	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N011559-001	BREVITAL SODIUM	METHOHEXITAL SODIUM	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N011559-002	BREVITAL SODIUM	METHOHEXITAL SODIUM	2.5GM/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982
N011559-003	BREVITAL SODIUM	METHOHEXITAL SODIUM	5GM/VIAL	INJECTABLE / INJECTION		Approved before 1982
N011559-004	BREVITAL SODIUM	METHOHEXITAL SODIUM	200MG/VIAL	INJECTABLE / INJECTION			2012-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N011559-001	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 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N011559-001	BREVITAL SODIUM	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N011559-002	BREVITAL SODIUM	2.5GM/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N011559-003	BREVITAL SODIUM	5GM/VIAL	INJECTABLE / INJECTION		Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N011559-004	BREVITAL SODIUM	200MG/VIAL	INJECTABLE / INJECTION			2012-12-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N011559-001	BREVITAL SODIUM	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011559-002	BREVITAL SODIUM	2.5GM/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011559-003	BREVITAL SODIUM	5GM/VIAL	INJECTABLE / INJECTION		Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011559-004	BREVITAL SODIUM	200MG/VIAL	INJECTABLE / INJECTION			2012-12-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N011559-001	BREVITAL SODIUM	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011559-002	BREVITAL SODIUM	2.5GM/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011559-003	BREVITAL SODIUM	5GM/VIAL	INJECTABLE / INJECTION		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011559-004	BREVITAL SODIUM	200MG/VIAL	INJECTABLE / INJECTION			2012-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N011559-001	BREVITAL SODIUM	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011559-002	BREVITAL SODIUM	2.5GM/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011559-003	BREVITAL SODIUM	5GM/VIAL	INJECTABLE / INJECTION		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011559-004	BREVITAL SODIUM	200MG/VIAL	INJECTABLE / INJECTION			2012-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011559-001	BREVITAL SODIUM	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011559-002	BREVITAL SODIUM	2.5GM/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011559-003	BREVITAL SODIUM	5GM/VIAL	INJECTABLE / INJECTION		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011559-004	BREVITAL SODIUM	200MG/VIAL	INJECTABLE / INJECTION			2012-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011559-001	BREVITAL SODIUM	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011559-002	BREVITAL SODIUM	2.5GM/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011559-003	BREVITAL SODIUM	5GM/VIAL	INJECTABLE / INJECTION		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011559-004	BREVITAL SODIUM	200MG/VIAL	INJECTABLE / INJECTION			2012-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011559-001	BREVITAL SODIUM	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011559-002	BREVITAL SODIUM	2.5GM/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011559-003	BREVITAL SODIUM	5GM/VIAL	INJECTABLE / INJECTION		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011559-004	BREVITAL SODIUM	200MG/VIAL	INJECTABLE / INJECTION			2012-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011559-001	BREVITAL SODIUM	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011559-002	BREVITAL SODIUM	2.5GM/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011559-003	BREVITAL SODIUM	5GM/VIAL	INJECTABLE / INJECTION		Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011559-004	BREVITAL SODIUM	200MG/VIAL	INJECTABLE / INJECTION			2012-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011559-001	BREVITAL SODIUM	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011559-002	BREVITAL SODIUM	2.5GM/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011559-003	BREVITAL SODIUM	5GM/VIAL	INJECTABLE / INJECTION		Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011559-004	BREVITAL SODIUM	200MG/VIAL	INJECTABLE / INJECTION			2012-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011559-001	BREVITAL SODIUM	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011559-002	BREVITAL SODIUM	2.5GM/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011559-003	BREVITAL SODIUM	5GM/VIAL	INJECTABLE / INJECTION		Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011559-004	BREVITAL SODIUM	200MG/VIAL	INJECTABLE / INJECTION			2012-12-21	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N011559-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N011559-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N011559-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N011559-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011559-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011559-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011559-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011559-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011559-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011559-001	AP	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011559-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011559-001	AP	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N011559-001	AP	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Brevital Sodium	METHOHEXITAL SODIUM	Par Health USA, LLC	eccd8340-ead3-4363-8902-0c19d33aa2ac	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 011559 application number: NDA011559 ndc (product): 42023-105

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42023-105	Brevital Sodium	methohexital sodium	Par Pharmaceutical, Inc.	NDA	Current
42023-105	Brevital Sodium	methohexital sodium	Par Pharmaceutical, Inc.	NDA	Current
42023-105	Brevital Sodium	methohexital sodium	Par Pharmaceutical, Inc.	NDA	Current
42023-105	Brevital Sodium	methohexital sodium	Par Pharmaceutical, Inc.	NDA	Current
42023-105	Brevital Sodium	methohexital sodium	Par Pharmaceutical, Inc.	NDA	Current
42023-106	Brevital Sodium	methohexital sodium	Par Pharmaceutical, Inc.	NDA	Current
42023-106	Brevital Sodium	methohexital sodium	Par Pharmaceutical, Inc.	NDA	Current
42023-106	Brevital Sodium	methohexital sodium	Par Pharmaceutical, Inc.	NDA	Current
42023-106	Brevital Sodium	methohexital sodium	Par Pharmaceutical, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65150	SUPPL	2020-11-04
65082	SUPPL	2020-10-30
48216	SUPPL	2017-05-02
48188	SUPPL	2017-05-02
33048	SUPPL	2014-01-28
272	SUPPL	2014-01-24
10766	SUPPL	2008-06-12
271	SUPPL	2008-05-08
11941	SUPPL	2004-06-01
10765	SUPPL	2004-06-01
11940	SUPPL	2004-05-28
11939	SUPPL	2001-07-13