FDA.reportPublic FDA data

Phenobarbital

Product NDC
69367-443
11-digit product format
693670443
Labeler code
69367
Product ID
69367-443_e9ead134-956a-408a-8546-3ab0e88229a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-03-06
Substance
PHENOBARBITAL
Active strength
64.8 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
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
2027-12-31

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 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198083Internal RxNorm lookup
198086Internal RxNorm lookup
198089Internal RxNorm lookup
199164Internal RxNorm lookup
199167Internal RxNorm lookup
199168Internal RxNorm lookup
312357Internal RxNorm lookup
312362Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e0276d32-80b9-4e06-85f9-3421a013be39Available 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
69367-443-01Phenobarbital100 in 1 BOTTLETABLET1001
69367-443-10Phenobarbital1000 in 1 BOTTLETABLET10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-443-01EA - Each69367-443ed514b9f-d67d-4ad1-83d9-5bad790e8fb312026-05-22
69367-443-10EA - Each69367-4431a31dc4f-bb94-4e40-b0bb-3d82e02d0eb412026-05-22

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, LLCe0276d32-80b9-4e06-85f9-3421a013be392026-03-12Warnings, Adverse reactionsExact identifier
ndc (product): 69367-443

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198083PHENobarbital 100 MG Oral TabletPSNe0276d32-80b9-4e06-85f9-3421a013be391
312357PHENobarbital 15 MG Oral TabletPSNe0276d32-80b9-4e06-85f9-3421a013be391
198086PHENobarbital 16.2 MG Oral TabletPSNe0276d32-80b9-4e06-85f9-3421a013be391
312362PHENobarbital 30 MG Oral TabletPSNe0276d32-80b9-4e06-85f9-3421a013be391
199167PHENobarbital 32.4 MG Oral TabletPSNe0276d32-80b9-4e06-85f9-3421a013be391
198089PHENobarbital 60 MG Oral TabletPSNe0276d32-80b9-4e06-85f9-3421a013be391
199168PHENobarbital 64.8 MG Oral TabletPSNe0276d32-80b9-4e06-85f9-3421a013be391
199164PHENobarbital 97.2 MG Oral TabletPSNe0276d32-80b9-4e06-85f9-3421a013be391
198083phenobarbital 100 MG Oral TabletSCDe0276d32-80b9-4e06-85f9-3421a013be391
312357phenobarbital 15 MG Oral TabletSCDe0276d32-80b9-4e06-85f9-3421a013be391
198086phenobarbital 16.2 MG Oral TabletSCDe0276d32-80b9-4e06-85f9-3421a013be391
312362phenobarbital 30 MG Oral TabletSCDe0276d32-80b9-4e06-85f9-3421a013be391
199167phenobarbital 32.4 MG Oral TabletSCDe0276d32-80b9-4e06-85f9-3421a013be391
198089phenobarbital 60 MG Oral TabletSCDe0276d32-80b9-4e06-85f9-3421a013be391
199168phenobarbital 64.8 MG Oral TabletSCDe0276d32-80b9-4e06-85f9-3421a013be391
199164phenobarbital 97.2 MG Oral TabletSCDe0276d32-80b9-4e06-85f9-3421a013be391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69367-443-0169367044301100 TABLET in 1 BOTTLE (69367-443-01) 100 tablet2026-03-06NoNoCurrent
69367-443-10693670443101000 TABLET in 1 BOTTLE (69367-443-10) 1000 tablet2026-03-06NoNoCurrent