Phenobarbital

Product NDC: 13517-110
11-digit product format: 135170110
Labeler code: 13517
Product ID: 13517-110_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: 16 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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	13517-110		D	Discontinued by firm	2026-08-17
excluded package	package	13517-110	13517-110-01	D	Discontinued by firm	2026-08-17
excluded package	package	13517-110	13517-110-10	D	Discontinued by firm	2026-08-17

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 date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13517-110-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13517-110-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13517-110-01	`f5e01cc5f278…`	`a2eaf40c39c3…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e3e67a66-d325-4d80-8f9d-059e736d7b00	Product name	1	20230912

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13517-110-01	EA - Each	13517-110	d38fff8a-e573-437e-89ce-d1dae9f1c514	1	2017-03-06
13517-110-10	EA - Each	13517-110	fafb9632-0140-4daf-afca-575bea7def0d	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13517-110	PHENOBARBITAL TABLET [E5 PHARMA, LLC]	10	Legacy NDC	20230804_1fd1c79c-37c3-40b8-983b-f88bb92e9ce7.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YQE403BP4D	PHENOBARBITAL	50-06-6	PHENOBARBITAL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13517-110-01	13517011001	100 TABLET in 1 BOTTLE (13517-110-01)	100 tablet	2017-02-24	0000-00-00	No	No	Current
13517-110-10	13517011010	1000 TABLET in 1 BOTTLE (13517-110-10)	1000 tablet	2017-02-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PHENOBARBITAL TABLETS, USP	e5 Pharma, LLC	2025-07-31	HUMAN PRESCRIPTION DRUG LABEL	11
PHENOBARBITAL TABLETS, USP	McKesson Corporation dba SKY Packaging \| Legacy Pharmaceutical Packaging, LLC	2025-03-05	HUMAN PRESCRIPTION DRUG LABEL	8
PHENOBARBITAL TABLETS, USP	Clinical Solutions Wholesale, LLC	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	3
PHENOBARBITAL TABLETS, USP	McKesson Corporation dba RX Pak	2019-07-10	HUMAN PRESCRIPTION DRUG LABEL	3