Phenobarbital Sodium

Product NDC
42494-442
Requested package NDC
42494-442-25
11-digit product format
424940442
Labeler code
42494
Product ID
42494-442_c8fe78ce-36e8-45f2-b23e-9dc6d62d56b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENOBARBITAL SODIUM
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Cameron Pharmaceuticals
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-06-02
Substance
PHENOBARBITAL SODIUM
Active strength
130 mg/mL
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42494-44242494-442-25UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42494-44242494-442-25UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42494-44242494-442-25UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Additional Listing Data#

Finished product
Yes
Brand name base
Phenobarbital Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOBARBITAL SODIUM130 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SW9M9BB5K3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198368Internal RxNorm lookup
312370Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9091250d-694a-4593-84dc-6fe54aef495fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e3e67a66-d325-4d80-8f9d-059e736d7b00Product name120230912

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42494-442-252025-02-11C16284748780-12cef2736-6966-d83d-e063-dadaa90ab31fPhenobarbital Sodium Injection, USP
42494-442-252025-01-30C16284748780-12cef2736-6966-d83d-e063-dadaa90ab31fPhenobarbital Sodium Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42494-442-25Phenobarbital Sodium1 mL in 1 VIALINJECTION13
42494-442-25Phenobarbital Sodium3 in 1 BOX, UNIT-DOSEINJECTION33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42494-442-25ML - Milliliter42494-4428d154ecd-72e4-40f5-921f-bfb3b02106a912023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42494-442PHENOBARBITAL SODIUM INJECTION [CAMERON PHARMACEUTICALS]2Current NDC, 2 package rows20250213_9091250d-694a-4593-84dc-6fe54aef495f.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenobarbital SodiumPHENOBARBITAL SODIUMCameron Pharmaceuticals9091250d-694a-4593-84dc-6fe54aef495f2025-06-04Adverse reactionsExact identifier
ndc (package): 42494-442-25
ndc (product): 42494-442
ndc11 (package): 42494044225

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312370PHENobarbital 130 MG/ML Injectable SolutionPSN9091250d-694a-4593-84dc-6fe54aef495f3
198368PHENobarbital 65 MG/ML Injectable SolutionPSN9091250d-694a-4593-84dc-6fe54aef495f3
312370phenobarbital 130 MG/ML Injectable SolutionSCD9091250d-694a-4593-84dc-6fe54aef495f3
198368phenobarbital 65 MG/ML Injectable SolutionSCD9091250d-694a-4593-84dc-6fe54aef495f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42494-442-25424940442253 VIAL in 1 BOX, UNIT-DOSE (42494-442-25) / 1 mL in 1 VIAL3 vial2023-06-02NoNoCurrent