FDA.reportPublic FDA data

Phenobarbital

Product NDC
13517-625
11-digit product format
135170625
Labeler code
13517
Product ID
13517-625_326d57e5-b0f8-439f-abd6-186f241e01ac
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
2026-09-30
Substance
PHENOBARBITAL
Active strength
16.2 mg/1
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage13517-62513517-625-01DDiscontinued by firm2026-08-11
excluded packagepackage13517-62513517-625-10DDiscontinued by firm2026-08-11

Additional Listing Data#

Finished product
Yes
Brand name base
Phenobarbital

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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198086Internal RxNorm lookup
199164Internal RxNorm lookup
199167Internal RxNorm lookup
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
884f7b62-160a-46c3-92d4-1031b255b76cAvailable 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
13517-625-01Phenobarbital100 in 1 BOTTLE, PLASTICTABLET10013
13517-625-10Phenobarbital1000 in 1 BOTTLE, PLASTICTABLET100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13517-625-01EA - Each13517-6259e7e5c6a-9f27-4001-b61c-f375170b2a9912023-01-09
13517-625-10EA - Each13517-625e7020b27-11b8-4eb3-81bf-9c686937779a12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13517-625PHENOBARBITAL TABLET [E5 PHARMA, LLC]12Current NDC, Legacy 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): 13517-625

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
13517-625-0113517062501100 TABLET in 1 BOTTLE, PLASTIC (13517-625-01) 100 tablet2022-11-302026-06-30NoNoCurrent
13517-625-10135170625101000 TABLET in 1 BOTTLE, PLASTIC (13517-625-10) 1000 tablet2022-11-300000-00-00NoNoCurrent