FDA.reportPublic FDA data

Phenobarbital

Product NDC
69367-627
11-digit product format
693670627
Labeler code
69367
Product ID
69367-627_d27572eb-a595-4050-a278-6a219541ad67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-09-08
Substance
PHENOBARBITAL
Active strength
64.8 mg/1
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
PHENOBARBITAL64.8 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198086Internal RxNorm lookup
199164Internal RxNorm lookup
199167Internal RxNorm lookup
199168Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f8ba853a-d699-4a91-a23d-9ac9b9dbe69aAvailable 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
69367-627-01Phenobarbital100 in 1 BOTTLETABLET1002
69367-627-10Phenobarbital1000 in 1 BOTTLETABLET10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-627PHENOBARBITAL TABLET [WESTMINSTER PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20230915_f8ba853a-d699-4a91-a23d-9ac9b9dbe69a.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, LLCf8ba853a-d699-4a91-a23d-9ac9b9dbe69a2025-12-01Warnings, Adverse reactionsExact identifier
ndc (product): 69367-627

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199168PHENobarbital 64.8 MG Oral TabletPSN4e6f2a3b-c6e2-488e-827a-e8646279532d3
199168phenobarbital 64.8 MG Oral TabletSCD4e6f2a3b-c6e2-488e-827a-e8646279532d3
198086PHENobarbital 16.2 MG Oral TabletPSNf8ba853a-d699-4a91-a23d-9ac9b9dbe69a2
199167PHENobarbital 32.4 MG Oral TabletPSNf8ba853a-d699-4a91-a23d-9ac9b9dbe69a2
199168PHENobarbital 64.8 MG Oral TabletPSNf8ba853a-d699-4a91-a23d-9ac9b9dbe69a2
199164PHENobarbital 97.2 MG Oral TabletPSNf8ba853a-d699-4a91-a23d-9ac9b9dbe69a2
198086phenobarbital 16.2 MG Oral TabletSCDf8ba853a-d699-4a91-a23d-9ac9b9dbe69a2
199167phenobarbital 32.4 MG Oral TabletSCDf8ba853a-d699-4a91-a23d-9ac9b9dbe69a2
199168phenobarbital 64.8 MG Oral TabletSCDf8ba853a-d699-4a91-a23d-9ac9b9dbe69a2
199164phenobarbital 97.2 MG Oral TabletSCDf8ba853a-d699-4a91-a23d-9ac9b9dbe69a2
198086PHENobarbital 16.2 MG Oral TabletPSN6b5ca781-50a9-4e89-8184-831c7c2936b21
199167PHENobarbital 32.4 MG Oral TabletPSN6b5ca781-50a9-4e89-8184-831c7c2936b21
199168PHENobarbital 64.8 MG Oral TabletPSN6b5ca781-50a9-4e89-8184-831c7c2936b21
199164PHENobarbital 97.2 MG Oral TabletPSN6b5ca781-50a9-4e89-8184-831c7c2936b21
198086phenobarbital 16.2 MG Oral TabletSCD6b5ca781-50a9-4e89-8184-831c7c2936b21
199167phenobarbital 32.4 MG Oral TabletSCD6b5ca781-50a9-4e89-8184-831c7c2936b21
199168phenobarbital 64.8 MG Oral TabletSCD6b5ca781-50a9-4e89-8184-831c7c2936b21
199164phenobarbital 97.2 MG Oral TabletSCD6b5ca781-50a9-4e89-8184-831c7c2936b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69367-627-0169367062701100 TABLET in 1 BOTTLE (69367-627-01) 100 tablet2023-09-08NoNoCurrent
69367-627-10693670627101000 TABLET in 1 BOTTLE (69367-627-10) 1000 tablet2023-09-08NoNoCurrent