Phenobarbital

Product NDC
13517-758
Requested package NDC
13517-758-05
11-digit product format
135170758
Labeler code
13517
Product ID
13517-758_ee1197e2-04ec-ce82-e053-2995a90a9097
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
e5 Pharma, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2019-03-21
Marketing end
0000-00-00
Substance
PHENOBARBITAL
Active strength
100 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage13517-75813517-758-05DDiscontinued by firm2026-10-15

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13517-758-01EA - Each13517-758f7d534b3-d4d3-4d0d-a8f9-29a0e30021f012019-08-06
13517-758-05EA - Each13517-758d55a28a8-ac60-4d12-9906-c57ad4f202e012019-08-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13517-758-0513517075805500 TABLET in 1 BOTTLE (13517-758-05) 500 tablet2019-03-210000-00-00NoNoCurrent