FDA.reportPublic FDA data

Phenobarbital

Product NDC
13517-627
11-digit product format
135170627
Labeler code
13517
Product ID
13517-627_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
65 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 productproduct13517-627DDiscontinued by firm2026-10-21
excluded packagepackage13517-62713517-627-01DDiscontinued by firm2026-10-21
excluded packagepackage13517-62713517-627-10DDiscontinued by firm2026-10-21

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
13517-627-01Phenobarbital100 in 1 BOTTLE, PLASTICTABLET10013
13517-627-10Phenobarbital1000 in 1 BOTTLE, PLASTICTABLET100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13517-627-01EA - Each13517-6275606157b-a824-4f1d-990f-fea6bade80a612023-01-09
13517-627-10EA - Each13517-627aae8533a-d39f-4eff-86ad-e8fe8ef6ea2312023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13517-627PHENOBARBITAL TABLET [E5 PHARMA, LLC]12Legacy NDC, 2 package rows20241031_884f7b62-160a-46c3-92d4-1031b255b76c.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13517-627-0113517062701100 TABLET in 1 BOTTLE, PLASTIC (13517-627-01) 100 tablet2022-11-300000-00-00NoNoCurrent
13517-627-10135170627101000 TABLET in 1 BOTTLE, PLASTIC (13517-627-10) 1000 tablet2022-11-300000-00-00NoNoCurrent