Brevital Sodium

Product NDC
42023-106
11-digit product format
420230106
Labeler code
42023
Product ID
42023-106_a1a2b87c-b11c-46de-b385-9b467db299b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methohexital sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; RECTAL
Labeler
Par Pharmaceutical, Inc.
Application
NDA011559
Marketing category
NDA
Marketing start
2007-11-01
Marketing end
2021-01-31
Substance
METHOHEXITAL SODIUM
Active strength
3 g/1
Pharmacologic classes
Barbiturate [EPC],Barbiturates [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42023-106DDiscontinued by firm2026-09-14
excluded packagepackage42023-10642023-106-01DDiscontinued by firm2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42023-106-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42023-106-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42023-106-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42023-106-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42023-106-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42023-106-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42023-106-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42023-106-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42023-106-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42023-106-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42023-106-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42023-106-01557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N011559-001BREVITAL SODIUMMETHOHEXITAL SODIUM500MG/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N011559-002BREVITAL SODIUMMETHOHEXITAL SODIUM2.5GM/VIALINJECTABLE / INJECTIONRLD, Approved before 1982
N011559-003BREVITAL SODIUMMETHOHEXITAL SODIUM5GM/VIALINJECTABLE / INJECTIONApproved before 1982
N011559-004BREVITAL SODIUMMETHOHEXITAL SODIUM200MG/VIALINJECTABLE / INJECTION2012-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N011559-001AP

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N011559-001BREVITAL SODIUM500MG/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N011559-002BREVITAL SODIUM2.5GM/VIALINJECTABLE / INJECTIONRLD, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N011559-003BREVITAL SODIUM5GM/VIALINJECTABLE / INJECTIONApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N011559-004BREVITAL SODIUM200MG/VIALINJECTABLE / INJECTION2012-12-2184e616aacf4f…
2026-08-18 06:07:402026-07N011559-001BREVITAL SODIUM500MG/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N011559-002BREVITAL SODIUM2.5GM/VIALINJECTABLE / INJECTIONRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N011559-003BREVITAL SODIUM5GM/VIALINJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N011559-004BREVITAL SODIUM200MG/VIALINJECTABLE / INJECTION2012-12-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N011559-001BREVITAL SODIUM500MG/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N011559-002BREVITAL SODIUM2.5GM/VIALINJECTABLE / INJECTIONRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N011559-003BREVITAL SODIUM5GM/VIALINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N011559-004BREVITAL SODIUM200MG/VIALINJECTABLE / INJECTION2012-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011559-001BREVITAL SODIUM500MG/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011559-002BREVITAL SODIUM2.5GM/VIALINJECTABLE / INJECTIONRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011559-003BREVITAL SODIUM5GM/VIALINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011559-004BREVITAL SODIUM200MG/VIALINJECTABLE / INJECTION2012-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N011559-001BREVITAL SODIUM500MG/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N011559-002BREVITAL SODIUM2.5GM/VIALINJECTABLE / INJECTIONRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N011559-003BREVITAL SODIUM5GM/VIALINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N011559-004BREVITAL SODIUM200MG/VIALINJECTABLE / INJECTION2012-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011559-001BREVITAL SODIUM500MG/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011559-002BREVITAL SODIUM2.5GM/VIALINJECTABLE / INJECTIONRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011559-003BREVITAL SODIUM5GM/VIALINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011559-004BREVITAL SODIUM200MG/VIALINJECTABLE / INJECTION2012-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011559-001BREVITAL SODIUM500MG/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011559-002BREVITAL SODIUM2.5GM/VIALINJECTABLE / INJECTIONRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011559-003BREVITAL SODIUM5GM/VIALINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011559-004BREVITAL SODIUM200MG/VIALINJECTABLE / INJECTION2012-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011559-001BREVITAL SODIUM500MG/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011559-002BREVITAL SODIUM2.5GM/VIALINJECTABLE / INJECTIONRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011559-003BREVITAL SODIUM5GM/VIALINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011559-004BREVITAL SODIUM200MG/VIALINJECTABLE / INJECTION2012-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011559-001BREVITAL SODIUM500MG/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011559-002BREVITAL SODIUM2.5GM/VIALINJECTABLE / INJECTIONRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011559-003BREVITAL SODIUM5GM/VIALINJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011559-004BREVITAL SODIUM200MG/VIALINJECTABLE / INJECTION2012-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N011559-001BREVITAL SODIUM500MG/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N011559-002BREVITAL SODIUM2.5GM/VIALINJECTABLE / INJECTIONRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N011559-003BREVITAL SODIUM5GM/VIALINJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N011559-004BREVITAL SODIUM200MG/VIALINJECTABLE / INJECTION2012-12-215bbf6a4d5a75…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N011559-001AP184e616aacf4f…
2026-08-18 06:07:402026-07N011559-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N011559-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011559-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N011559-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011559-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011559-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011559-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011559-001AP12680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N011559-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N011559-001AP1d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N011559-001AP1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42023-106-01EA - Each42023-106c85d977c-c914-451f-9cdd-ee24c21e065312012-07-24

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Brevital SodiumMETHOHEXITAL SODIUMPar Health USA, LLCeccd8340-ead3-4363-8902-0c19d33aa2ac2026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 011559
application number: NDA011559