FDA.reportPublic FDA data

Phenobarbital

Product NDC
13517-626
11-digit product format
135170626
Labeler code
13517
Product ID
13517-626_3e369840-e7af-4ab9-b787-81ff6cdd9559
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
e5 Pharma, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-11-30
Marketing end
0000-00-00
Substance
PHENOBARBITAL
Active strength
32 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct13517-626DDiscontinued by firm2026-10-02
excluded packagepackage13517-62613517-626-01DDiscontinued by firm2026-10-02
excluded packagepackage13517-62613517-626-10DDiscontinued by firm2026-10-02

Reported adverse events (FAERS/openFDA)#

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

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
13517-626-01Phenobarbital100 in 1 BOTTLE, PLASTICTABLET10013
13517-626-10Phenobarbital1000 in 1 BOTTLE, PLASTICTABLET100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13517-626-01EA - Each13517-62658696190-ee20-4563-8c00-b984b5dc8d2f12023-01-09
13517-626-10EA - Each13517-626e07088c2-9e3f-4172-8fce-fee2be8a575712023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13517-626PHENOBARBITAL TABLET [E5 PHARMA, LLC]12Legacy NDC, 2 package rows20241031_884f7b62-160a-46c3-92d4-1031b255b76c.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
PhenobarbitalPHENOBARBITALe5 Pharma, LLC884f7b62-160a-46c3-92d4-1031b255b76c2025-07-31Warnings, Adverse reactionsExact identifier
ndc (product): 13517-626

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198086PHENobarbital 16.2 MG Oral TabletPSN884f7b62-160a-46c3-92d4-1031b255b76c13
199167PHENobarbital 32.4 MG Oral TabletPSN884f7b62-160a-46c3-92d4-1031b255b76c13
199168PHENobarbital 64.8 MG Oral TabletPSN884f7b62-160a-46c3-92d4-1031b255b76c13
199164PHENobarbital 97.2 MG Oral TabletPSN884f7b62-160a-46c3-92d4-1031b255b76c13
198086phenobarbital 16.2 MG Oral TabletSCD884f7b62-160a-46c3-92d4-1031b255b76c13
199167phenobarbital 32.4 MG Oral TabletSCD884f7b62-160a-46c3-92d4-1031b255b76c13
199168phenobarbital 64.8 MG Oral TabletSCD884f7b62-160a-46c3-92d4-1031b255b76c13
199164phenobarbital 97.2 MG Oral TabletSCD884f7b62-160a-46c3-92d4-1031b255b76c13
199167PHENobarbital 32.4 MG Oral TabletPSN8483f082-131d-4218-81d7-61c716af65b52
199167phenobarbital 32.4 MG Oral TabletSCD8483f082-131d-4218-81d7-61c716af65b52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13517-626-0113517062601100 TABLET in 1 BOTTLE, PLASTIC (13517-626-01) 100 tablet2022-11-300000-00-00NoNoCurrent
13517-626-10135170626101000 TABLET in 1 BOTTLE, PLASTIC (13517-626-10) 1000 tablet2022-11-300000-00-00NoNoCurrent