Phenobarbital

Product NDC
13517-113
11-digit product format
135170113
Labeler code
13517
Product ID
13517-113_ee1174cb-83ee-4b74-e053-2995a90a049a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
e5 Pharma, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2017-02-24
Marketing end
0000-00-00
Substance
PHENOBARBITAL
Active strength
97 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 productproduct13517-113DDiscontinued by firm2026-08-17
excluded packagepackage13517-11313517-113-01DDiscontinued by firm2026-08-17
excluded packagepackage13517-11313517-113-10DDiscontinued 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 · 4 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 packagepackage13517-113-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13517-113-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13517-113-10f5e01cc5f278…a2eaf40c39c3…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13517-113-01EA - Each13517-113f22d1550-6246-4f54-a571-c0f3b60e07cf12017-03-06
13517-113-10EA - Each13517-113381d933d-2039-4c59-81c9-053ecc27a08d12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13517-113PHENOBARBITAL TABLET [E5 PHARMA, LLC]10Legacy NDC20230804_1fd1c79c-37c3-40b8-983b-f88bb92e9ce7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13517-113-0113517011301100 TABLET in 1 BOTTLE (13517-113-01) 100 tablet2017-02-240000-00-00NoNoCurrent
13517-113-10135170113101000 TABLET in 1 BOTTLE (13517-113-10) 1000 tablet2017-02-240000-00-00NoNoCurrent