FDA.reportPublic FDA data

Phenobarbital

Product NDC
72162-1265
Requested package NDC
72162-1265-0
11-digit product format
721621265
Labeler code
72162
Product ID
72162-1265_0308bc99-4ace-43f0-9d40-cfef627ad1a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-11-01
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
b099ff66-da3d-47a1-b721-8b5b5e4a13baAvailable 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
72162-1265-0Phenobarbital1000 in 1 BOTTLETABLET1000100
72162-1265-1Phenobarbital100 in 1 BOTTLETABLET100100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1265-0EA - Each72162-12650517864e-18b0-45c7-82f4-cfa76a60f68c12024-01-04
72162-1265-1EA - Each72162-12652f3020e0-d100-4ee5-b7d7-aacb214b172712024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1265PHENOBARBITAL TABLET [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20230914_b099ff66-da3d-47a1-b721-8b5b5e4a13ba.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
PhenobarbitalPHENOBARBITALBryant Ranch Prepackb099ff66-da3d-47a1-b721-8b5b5e4a13ba2023-09-13Warnings, Adverse reactionsExact identifier
ndc (package): 72162-1265-0
ndc (product): 72162-1265
ndc11 (package): 72162126500

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199168PHENobarbital 64.8 MG Oral TabletPSNb099ff66-da3d-47a1-b721-8b5b5e4a13ba100
199168phenobarbital 64.8 MG Oral TabletSCDb099ff66-da3d-47a1-b721-8b5b5e4a13ba100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1265-0721621265001000 TABLET in 1 BOTTLE (72162-1265-0) 1000 tablet2023-09-13NoNoCurrent