FDA.reportPublic FDA data

Phenobarbital

Product NDC
62135-405
11-digit product format
621350405
Labeler code
62135
Product ID
62135-405_45ae5eb0-ee63-8c29-e063-6294a90a2e42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2014-11-24
Substance
PHENOBARBITAL
Active strength
16.2 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
PHENOBARBITAL16.2 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
fa83619c-81b9-4e69-b36e-46e396bb7286Available 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
62135-405-12Phenobarbital120 in 1 BOTTLETABLET1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-405PHENOBARBITAL TABLET [CHARTWELL RX, LLC]3Current NDC, Legacy NDC, 1 package rows20241013_fa83619c-81b9-4e69-b36e-46e396bb7286.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
PhenobarbitalPHENOBARBITALChartwell RX, LLCfa83619c-81b9-4e69-b36e-46e396bb72862025-12-11Warnings, Adverse reactionsExact identifier
ndc (product): 62135-405

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198083PHENobarbital 100 MG Oral TabletPSNfa83619c-81b9-4e69-b36e-46e396bb72864
312357PHENobarbital 15 MG Oral TabletPSNfa83619c-81b9-4e69-b36e-46e396bb72864
198086PHENobarbital 16.2 MG Oral TabletPSNfa83619c-81b9-4e69-b36e-46e396bb72864
312362PHENobarbital 30 MG Oral TabletPSNfa83619c-81b9-4e69-b36e-46e396bb72864
199167PHENobarbital 32.4 MG Oral TabletPSNfa83619c-81b9-4e69-b36e-46e396bb72864
198089PHENobarbital 60 MG Oral TabletPSNfa83619c-81b9-4e69-b36e-46e396bb72864
199168PHENobarbital 64.8 MG Oral TabletPSNfa83619c-81b9-4e69-b36e-46e396bb72864
199164PHENobarbital 97.2 MG Oral TabletPSNfa83619c-81b9-4e69-b36e-46e396bb72864
198083phenobarbital 100 MG Oral TabletSCDfa83619c-81b9-4e69-b36e-46e396bb72864
312357phenobarbital 15 MG Oral TabletSCDfa83619c-81b9-4e69-b36e-46e396bb72864
198086phenobarbital 16.2 MG Oral TabletSCDfa83619c-81b9-4e69-b36e-46e396bb72864
312362phenobarbital 30 MG Oral TabletSCDfa83619c-81b9-4e69-b36e-46e396bb72864
199167phenobarbital 32.4 MG Oral TabletSCDfa83619c-81b9-4e69-b36e-46e396bb72864
198089phenobarbital 60 MG Oral TabletSCDfa83619c-81b9-4e69-b36e-46e396bb72864
199168phenobarbital 64.8 MG Oral TabletSCDfa83619c-81b9-4e69-b36e-46e396bb72864
199164phenobarbital 97.2 MG Oral TabletSCDfa83619c-81b9-4e69-b36e-46e396bb72864

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-405-1262135040512120 TABLET in 1 BOTTLE (62135-405-12) 120 tablet2022-09-010000-00-00NoNoCurrent