Phenobarbital

Product NDC
13517-107
11-digit product format
135170107
Labeler code
13517
Product ID
13517-107_ee1174cb-83ed-4b74-e053-2995a90a049a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenobarbital
Dosage form
ELIXIR
Route
ORAL
Labeler
e5 Pharma, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2017-11-17
Marketing end
0000-00-00
Substance
PHENOBARBITAL
Active strength
20 mg/5mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct13517-107DDiscontinued by firm2026-08-17
excluded packagepackage13517-10713517-107-16DDiscontinued 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 packagepackage13517-107-16d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13517-107-16f5e01cc5f278…a2eaf40c39c3…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13517-107-16ML - Milliliter13517-107add4ec0b-76c0-4ca5-ae40-ea25f0560f0412018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13517-107PHENOBARBITAL ELIXIR [E5 PHARMA, LLC]8Legacy NDC20241009_1e34926f-e5e5-41da-836a-c854b00d1a20.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13517-107-1613517010716473 mL in 1 BOTTLE, PLASTIC (13517-107-16) 473 ml2017-11-170000-00-00NoNoCurrent