FDA.reportPublic FDA data

Phenobarbital

Product NDC
58118-1626
11-digit product format
581181626
Labeler code
58118
Product ID
58118-1626_0e8814e5-056b-eef6-e063-6394a90a23cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-11-30
Substance
PHENOBARBITAL
Active strength
32.4 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOBARBITAL32.4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YQE403BP4DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199167Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8483f082-131d-4218-81d7-61c716af65b5Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58118-1626-8Phenobarbital30 in 1 BLISTER PACKTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-1626PHENOBARBITAL TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]2Current NDC, 1 package rows20240110_8483f082-131d-4218-81d7-61c716af65b5.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
PhenobarbitalPHENOBARBITALClinical Solutions Wholesale, LLC8483f082-131d-4218-81d7-61c716af65b52024-01-09Warnings, Adverse reactionsExact identifier
ndc (product): 58118-1626

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199167PHENobarbital 32.4 MG Oral TabletPSN8483f082-131d-4218-81d7-61c716af65b52
199167phenobarbital 32.4 MG Oral TabletSCD8483f082-131d-4218-81d7-61c716af65b52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58118-1626-85811816260830 TABLET in 1 BLISTER PACK (58118-1626-8) 30 tablet2023-01-27NoNoCurrent