Phenobarbital

Product NDC: 0603-1508
11-digit product format: 006031508
Labeler code: 0603
Product ID: 0603-1508_65e7e1ed-5a7c-4e01-9d97-5286b531eb29
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: phenobarbital
Dosage form: ELIXIR
Route: ORAL
Labeler: Par Pharmaceutical
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 1997-01-01
Marketing end: 2024-02-29
Substance: PHENOBARBITAL
Active strength: 20 mg/5mL
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 0000-00-00
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0603-1508		D	Discontinued by firm		2026-08-17
excluded package	package	0603-1508	0603-1508-58	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 · 24 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	0603-1508-58	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0603-1508-58	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0603-1508-58	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0603-1508-58	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0603-1508-58	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0603-1508-58	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0603-1508-58	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0603-1508-58	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0603-1508-58	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0603-1508-58	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0603-1508-58	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0603-1508-58	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e3e67a66-d325-4d80-8f9d-059e736d7b00	Product name	1	20230912
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-1508-58	ML - Milliliter	0603-1508	612172c5-3517-4d75-b217-b2862e15e818	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENOBARBITAL	ACTIVE INGREDIENT	YQE403BP4D	PHENOBARBITAL ELIXIR [ATLANTIC BIOLOGICALS CORPS]	4
PHENOBARBITAL	ACTIVE MOIETY	YQE403BP4D	PHENOBARBITAL ELIXIR [ATLANTIC BIOLOGICALS CORPS]	4
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PHENOBARBITAL ELIXIR [ATLANTIC BIOLOGICALS CORPS]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PHENOBARBITAL ELIXIR [ATLANTIC BIOLOGICALS CORPS]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PHENOBARBITAL ELIXIR [ATLANTIC BIOLOGICALS CORPS]	4
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PHENOBARBITAL ELIXIR [ATLANTIC BIOLOGICALS CORPS]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	PHENOBARBITAL ELIXIR [ATLANTIC BIOLOGICALS CORPS]	4
PHENOBARBITAL	ACTIVE INGREDIENT	YQE403BP4D	PHENOBARBITAL ELIXIR [QUALITEST PHARMACEUTICALS]	2
PHENOBARBITAL	ACTIVE MOIETY	YQE403BP4D	PHENOBARBITAL ELIXIR [QUALITEST PHARMACEUTICALS]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PHENOBARBITAL ELIXIR [QUALITEST PHARMACEUTICALS]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PHENOBARBITAL ELIXIR [QUALITEST PHARMACEUTICALS]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PHENOBARBITAL ELIXIR [QUALITEST PHARMACEUTICALS]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PHENOBARBITAL ELIXIR [QUALITEST PHARMACEUTICALS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	PHENOBARBITAL ELIXIR [QUALITEST PHARMACEUTICALS]	2

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
702519	PHENobarbital 20 MG in 5 mL Oral Solution	PSN	0e2ce036-5b74-4aa6-8a6b-57452315b769	5
702519	phenobarbital 4 MG/ML Oral Solution	SCD	0e2ce036-5b74-4aa6-8a6b-57452315b769	5
702519	phenobarbital 20 MG per 5 ML Oral Solution	SY	0e2ce036-5b74-4aa6-8a6b-57452315b769	5
702519	phenobarbital 30 MG per 7.5 ML Oral Solution	SY	0e2ce036-5b74-4aa6-8a6b-57452315b769	5
702519	phenobarbital 60 MG per 15 ML Oral Solution	SY	0e2ce036-5b74-4aa6-8a6b-57452315b769	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0603-1508-58	00603150858	473 mL in 1 BOTTLE, PLASTIC (0603-1508-58)	473 ml	1997-01-01	2024-02-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PHENOBARBITAL ELIXIR, USP CIV Rx Only 8444867/0319FA	American Health Packaging	2022-12-22	HUMAN PRESCRIPTION DRUG LABEL	3
PHENOBARBITAL ELIXIR, USP CIV Rx only	Par Pharmaceutical \| Par Pharmaceutical Inc.	2022-05-03	HUMAN PRESCRIPTION DRUG LABEL	5
PHENOBARBITAL ELIXIR, USP CIV Rx only	Atlantic Biologicals Corps	2019-10-24	HUMAN PRESCRIPTION DRUG LABEL	5