FDA.reportPublic FDA data

Pentobarbital Sodium

Product NDC
24201-010
11-digit product format
242010010
Labeler code
24201
Product ID
24201-010_092d00fe-9f8a-47ea-b9bc-07ef41d2b418
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pentobarbital Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA203619
Marketing category
ANDA
Marketing start
2025-10-01
Substance
PENTOBARBITAL SODIUM
Active strength
50 mg/mL
DEA schedule
CII
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203619-001PENTOBARBITAL SODIUMPENTOBARBITAL SODIUM50MG/MLINJECTABLE / INJECTIONAP2017-11-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203619-001AP

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
2026-08-01 22:54:322026-06A203619-001PENTOBARBITAL SODIUM50MG/MLINJECTABLE / INJECTIONAP2017-11-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203619-001AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pentobarbital SodiumPENTOBARBITAL SODIUMHikma Pharmaceuticals USA Inc.d375b92a-baa1-4d63-9ad1-1467dcfde7d52024-03-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203619
application number: ANDA203619
ndc (product): 24201-010

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PENTOBARBITAL SODIUM50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NJJ0475N0SInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
238090Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d375b92a-baa1-4d63-9ad1-1467dcfde7d5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a608f88c-baa8-0098-ce26-66cf9faa6b64Product name320180110

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24201-010-20Pentobarbital Sodium1 in 1 CARTONINJECTION, SOLUTION15
24201-010-20Pentobarbital Sodium20 mL in 1 VIALINJECTION, SOLUTION205
24201-010-50Pentobarbital Sodium1 in 1 CARTONINJECTION, SOLUTION15
24201-010-50Pentobarbital Sodium50 mL in 1 VIALINJECTION, SOLUTION505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24201-010-20ML - Milliliter24201-010a937c480-228a-4456-a027-23f6eba2a40f12018-03-08
24201-010-50ML - Milliliter24201-010fd306243-897a-4767-bcd2-60f65397a6b512018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24201-010PENTOBARBITAL SODIUM INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC. (DBA LEUCADIA PHARMACEUTICALS)]4Current NDC, Legacy NDC, 4 package rows20230111_d375b92a-baa1-4d63-9ad1-1467dcfde7d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238090PENTobarbital sodium 50 MG/ML Injectable SolutionPSNd375b92a-baa1-4d63-9ad1-1467dcfde7d55
238090pentobarbital sodium 50 MG/ML Injectable SolutionSCDd375b92a-baa1-4d63-9ad1-1467dcfde7d55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24201-010-20242010010201 VIAL in 1 CARTON (24201-010-20) / 20 mL in 1 VIAL1 vial2025-10-010000-00-00NoNoCurrent
24201-010-50242010010501 VIAL in 1 CARTON (24201-010-50) / 50 mL in 1 VIAL1 vial2025-10-010000-00-00NoNoCurrent