Home NDC 42023-105 Brevital Sodium
Product NDC 42023-105
11-digit product format 420230105
Labeler code 42023
Product ID 42023-105_6efcbde7-9a3d-4d12-93ea-793a9e72725a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methohexital sodium
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; RECTAL
Labeler Par Health USA, LLC
Application NDA011559
Marketing category NDA
Marketing start 2007-11-01
Substance METHOHEXITAL SODIUM
Active strength 500 mg/1
Pharmacologic classes Barbiturate [EPC], Barbiturates [CS]
DEA schedule CIV
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 · 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 · 172 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 2026-09-14 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…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N011559-001 BREVITAL SODIUM 500MG/VIAL INJECTABLE / INJECTION RLD, RS, Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N011559-002 BREVITAL SODIUM 2.5GM/VIAL INJECTABLE / INJECTION RLD, Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N011559-003 BREVITAL SODIUM 5GM/VIAL INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N011559-004 BREVITAL SODIUM 200MG/VIAL INJECTABLE / INJECTION 2012-12-21 5bbf6a4d5a75…
Observed Orange Book normalized TE history# 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 Brevital Sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHOHEXITAL SODIUM 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 60200PNZ7Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1244233 Internal RxNorm lookup 1244638 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42023-105-01 Brevital Sodium 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 18 42023-105-01 Brevital Sodium 1 in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded methohexital sodium ACTIVE INGREDIENT 60200PNZ7Q BREVITAL SODIUM (METHOHEXITAL SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PAR PHARMACEUTICAL, INC.] 6 methohexital ACTIVE MOIETY E5B8ND5IPE BREVITAL SODIUM (METHOHEXITAL SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PAR PHARMACEUTICAL, INC.] 6 SODIUM CARBONATE INACTIVE INGREDIENT 45P3261C7T BREVITAL SODIUM (METHOHEXITAL SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PAR PHARMACEUTICAL, INC.] 6 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I BREVITAL SODIUM (METHOHEXITAL SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PAR PHARMACEUTICAL, INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42023-105 BREVITAL SODIUM (METHOHEXITAL SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ENDO USA, INC.] 16 Current NDC, Legacy NDC, 2 package rows 20240913_eccd8340-ead3-4363-8902-0c19d33aa2ac.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42023-105-01 42023010501 1 VIAL in 1 CARTON (42023-105-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL 1 vial 2007-11-01 0000-00-00 No No Current