Home NDC 83270-003 Methohexital Sodium
Product NDC 83270-003
11-digit product format 832700003
Labeler code 83270
Product ID 83270-003_4b14107a-95d4-0f90-e063-6394a90a0eb3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methohexital Sodium
Dosage form INJECTION
Route INTRAVENOUS
Labeler ONESOURCE SPECIALTY PHARMA LIMITED
Application ANDA215488
Marketing category ANDA
Marketing start 2026-01-24
Substance METHOHEXITAL SODIUM
Active strength 500 mg/500mg
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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215488-001 METHOHEXITAL SODIUM METHOHEXITAL SODIUM 500MG/VIAL INJECTABLE / INJECTION AP 2024-10-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215488-001 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.
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 2026-02-19 14:30 UTC 2026-02 A215488-001 METHOHEXITAL SODIUM 500MG/VIAL INJECTABLE / INJECTION AP 2024-10-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215488-001 METHOHEXITAL SODIUM 500MG/VIAL INJECTABLE / INJECTION AP 2024-10-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215488-001 METHOHEXITAL SODIUM 500MG/VIAL INJECTABLE / INJECTION AP 2024-10-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215488-001 METHOHEXITAL SODIUM 500MG/VIAL INJECTABLE / INJECTION AP 2024-10-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215488-001 METHOHEXITAL SODIUM 500MG/VIAL INJECTABLE / INJECTION AP 2024-10-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215488-001 METHOHEXITAL SODIUM 500MG/VIAL INJECTABLE / INJECTION AP 2024-10-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215488-001 METHOHEXITAL SODIUM 500MG/VIAL INJECTABLE / INJECTION AP 2024-10-03 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215488-001 METHOHEXITAL SODIUM 500MG/VIAL INJECTABLE / INJECTION AP 2024-10-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215488-001 METHOHEXITAL SODIUM 500MG/VIAL INJECTABLE / INJECTION AP 2024-10-03 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215488-001 METHOHEXITAL SODIUM 500MG/VIAL INJECTABLE / INJECTION AP 2024-10-03 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215488-001 CGT 2025-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215488-001 CGT 2025-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215488-001 CGT 2025-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215488-001 CGT 2025-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215488-001 CGT 2025-06-10 03ed91905a0d…
Additional Listing Data#
Finished product Yes
Brand name base Methohexital Sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHOHEXITAL SODIUM 500 mg/500mg
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1244233 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 83270-003-01 Methohexital Sodium 500 mg in 1 VIAL INJECTION 500 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83270-003 METHOHEXITAL SODIUM INJECTION [ONESOURCE SPECIALTY PHARMA LIMITED] 3 Current NDC, 1 package rows 20250523_6fb09acf-4937-47a0-a9da-084ec062da6f.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83270-003-01 83270000301 500 mg in 1 VIAL (83270-003-01) 500 mg 2026-01-24 No No Current