FDA.reportPublic FDA data

Phenobarbital

Product NDC
69367-357
11-digit product format
693670357
Labeler code
69367
Product ID
69367-357_829b32b5-8c54-455c-83cb-d8dfb7d4407f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
LIQUID
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-10-13
Substance
PHENOBARBITAL
Active strength
20 mg/5mL
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOBARBITAL20 mg/5mL

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
702519Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0ca8847d-1966-47a0-995e-a5c0d2fd699dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e3e67a66-d325-4d80-8f9d-059e736d7b00Product name120230912
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-357-16Phenobarbital473 mL in 1 BOTTLELIQUID4733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-357PHENOBARBITAL LIQUID [WESTMINSTER PHARMACEUTICALS, LLC]3Current NDC, 1 package rows20240210_0ca8847d-1966-47a0-995e-a5c0d2fd699d.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
PhenobarbitalPHENOBARBITALWestminster Pharmaceuticals, LLC0ca8847d-1966-47a0-995e-a5c0d2fd699d2023-10-12Warnings, Adverse reactionsExact identifier
ndc (product): 69367-357

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702519PHENobarbital 20 MG in 5 mL Oral SolutionPSN0ca8847d-1966-47a0-995e-a5c0d2fd699d3
702519phenobarbital 4 MG/ML Oral SolutionSCD0ca8847d-1966-47a0-995e-a5c0d2fd699d3
702519phenobarbital 20 MG per 5 ML Oral SolutionSY0ca8847d-1966-47a0-995e-a5c0d2fd699d3
702519phenobarbital 30 MG per 7.5 ML Oral SolutionSY0ca8847d-1966-47a0-995e-a5c0d2fd699d3
702519phenobarbital 60 MG per 15 ML Oral SolutionSY0ca8847d-1966-47a0-995e-a5c0d2fd699d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69367-357-1669367035716473 mL in 1 BOTTLE (69367-357-16) 473 ml2023-10-13NoNoCurrent