Methohexital Sodium

Product NDC
23155-893
11-digit product format
231550893
Labeler code
23155
Product ID
23155-893_9ec15df7-278e-4cf3-bc97-e480b4671ca6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methohexital Sodium
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS; RECTAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA215488
Marketing category
ANDA
Marketing start
2024-12-12
Substance
METHOHEXITAL SODIUM
Active strength
500 mg/500mg
Pharmacologic classes
Barbiturate [EPC], Barbiturates [CS]
DEA schedule
CIV
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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215488-001METHOHEXITAL SODIUMMETHOHEXITAL SODIUM500MG/VIALINJECTABLE / INJECTIONAP2024-10-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215488-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A215488-001METHOHEXITAL SODIUM500MG/VIALINJECTABLE / INJECTIONAP2024-10-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215488-001METHOHEXITAL SODIUM500MG/VIALINJECTABLE / INJECTIONAP2024-10-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A215488-001METHOHEXITAL SODIUM500MG/VIALINJECTABLE / INJECTIONAP2024-10-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215488-001METHOHEXITAL SODIUM500MG/VIALINJECTABLE / INJECTIONAP2024-10-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215488-001METHOHEXITAL SODIUM500MG/VIALINJECTABLE / INJECTIONAP2024-10-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215488-001METHOHEXITAL SODIUM500MG/VIALINJECTABLE / INJECTIONAP2024-10-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215488-001METHOHEXITAL SODIUM500MG/VIALINJECTABLE / INJECTIONAP2024-10-032680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215488-001METHOHEXITAL SODIUM500MG/VIALINJECTABLE / INJECTIONAP2024-10-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215488-001METHOHEXITAL SODIUM500MG/VIALINJECTABLE / INJECTIONAP2024-10-03d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215488-001METHOHEXITAL SODIUM500MG/VIALINJECTABLE / INJECTIONAP2024-10-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A215488-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215488-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215488-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215488-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215488-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215488-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215488-001AP12680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215488-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215488-001AP1d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215488-001AP1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215488-001CGT2025-06-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A215488-001CGT2025-06-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215488-001CGT2025-06-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215488-001CGT2025-06-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215488-001CGT2025-06-1003ed91905a0d…

Additional Listing Data#

Finished product
Yes
Brand name base
Methohexital Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOHEXITAL SODIUM500 mg/500mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
60200PNZ7QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1244233Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f76d4ab9-2f6c-420b-afec-b9cdfdc083ceAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b09eb988-ff06-ac5d-8b4f-d03286b85818Product name320250429

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-893-31Methohexital Sodium1 in 1 CARTONINJECTION12
23155-893-31Methohexital Sodium500 mg in 1 VIALINJECTION5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-893-31EA - Each23155-8934066bd6a-7ccd-4f0b-9d41-ffe9198a7d3412025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-893METHOHEXITAL SODIUM INJECTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]2Current NDC, 2 package rows20241218_f76d4ab9-2f6c-420b-afec-b9cdfdc083ce.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methohexital SodiumMETHOHEXITAL SODIUMHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.f76d4ab9-2f6c-420b-afec-b9cdfdc083ce2026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215488
application number: ANDA215488
ndc (product): 23155-893
Methohexital SodiumMETHOHEXITAL SODIUMONESOURCE SPECIALTY PHARMA LIMITED6fb09acf-4937-47a0-a9da-084ec062da6f2026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215488
application number: ANDA215488

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1244233methohexital sodium Variable Concentration Multi-Use Injectable SolutionPSNf76d4ab9-2f6c-420b-afec-b9cdfdc083ce2
1244233methohexital sodium 50 MG/ML Injectable SolutionSCDf76d4ab9-2f6c-420b-afec-b9cdfdc083ce2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
23155-893-31231550893311 VIAL in 1 CARTON (23155-893-31) / 500 mg in 1 VIAL1 vial2024-12-12NoNoCurrent