FDA.reportPublic FDA data

Phenobarbital

Product NDC
13517-691
11-digit product format
135170691
Labeler code
13517
Product ID
13517-691_30bb64f1-4c1f-41c6-b209-566a030672a3
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
15 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 productproduct13517-691DDiscontinued by firm2026-08-17
excluded packagepackage13517-69113517-691-01DDiscontinued by firm2026-08-17
excluded packagepackage13517-69113517-691-05DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13517-691-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13517-691-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13517-691-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13517-691-05f5e01cc5f278…a2eaf40c39c3…

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
13517-691-01Phenobarbital100 in 1 BOTTLE, PLASTICTABLET10012
13517-691-05Phenobarbital500 in 1 BOTTLE, PLASTICTABLET50012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13517-691-01EA - Each13517-6913eb434f1-4e8c-4c6c-987d-74a7a651ef1412023-01-09
13517-691-05EA - Each13517-691e735bb0c-68ae-4b3d-bfe3-b918fb9d728f12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13517-691PHENOBARBITAL TABLET [E5 PHARMA, LLC]11Legacy NDC, 2 package rows20241031_5c4efd5a-75be-480b-ac31-40dd66feada1.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, LLC5c4efd5a-75be-480b-ac31-40dd66feada12025-07-31Warnings, Adverse reactionsExact identifier
ndc (product): 13517-691

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198083PHENobarbital 100 MG Oral TabletPSN5c4efd5a-75be-480b-ac31-40dd66feada112
312357PHENobarbital 15 MG Oral TabletPSN5c4efd5a-75be-480b-ac31-40dd66feada112
312362PHENobarbital 30 MG Oral TabletPSN5c4efd5a-75be-480b-ac31-40dd66feada112
198089PHENobarbital 60 MG Oral TabletPSN5c4efd5a-75be-480b-ac31-40dd66feada112
198083phenobarbital 100 MG Oral TabletSCD5c4efd5a-75be-480b-ac31-40dd66feada112
312357phenobarbital 15 MG Oral TabletSCD5c4efd5a-75be-480b-ac31-40dd66feada112
312362phenobarbital 30 MG Oral TabletSCD5c4efd5a-75be-480b-ac31-40dd66feada112
198089phenobarbital 60 MG Oral TabletSCD5c4efd5a-75be-480b-ac31-40dd66feada112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13517-691-0113517069101100 TABLET in 1 BOTTLE, PLASTIC (13517-691-01) 100 tablet2022-11-300000-00-00NoNoCurrent
13517-691-0513517069105500 TABLET in 1 BOTTLE, PLASTIC (13517-691-05) 500 tablet2022-11-300000-00-00NoNoCurrent