Phenobarbital

Product NDC: 67544-057
11-digit product format: 675440057
Labeler code: 67544
Product ID: 67544-057_31c3f6b2-2ac4-440f-90bc-15aae152d990
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: phenobarbital
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2003-02-01
Marketing end: 0000-00-00
Substance: PHENOBARBITAL
Active strength: 32 mg/1
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67544-057		I	Inactivated by FDA	2026-10-12
excluded package	package	67544-057	67544-057-30	I	Inactivated by FDA	2026-10-12
excluded package	package	67544-057	67544-057-53	I	Inactivated by FDA	2026-10-12
excluded package	package	67544-057	67544-057-60	I	Inactivated by FDA	2026-10-12
excluded package	package	67544-057	67544-057-70	I	Inactivated by FDA	2026-10-12
excluded package	package	67544-057	67544-057-75	I	Inactivated by FDA	2026-10-12
excluded package	package	67544-057	67544-057-80	I	Inactivated by FDA	2026-10-12
excluded package	package	67544-057	67544-057-92	I	Inactivated by FDA	2026-10-12
excluded package	package	67544-057	67544-057-94	I	Inactivated by FDA	2026-10-12

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 4 · 189 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	67544-057-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-057-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-057-75	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-057-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-057-70	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-057-92	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-057-94	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-057-53	`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	67544-057-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-057-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-057-75	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-057-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-057-70	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-057-92	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-057-94	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-057-53	`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	67544-057-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-057-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-057-75	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-057-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-057-70	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-057-92	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-057-94	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-057-53	`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	67544-057-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-057-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-057-75	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-057-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-057-70	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-057-92	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-057-94	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-057-53	`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	67544-057-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-057-80	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-057-75	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-057-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-057-70	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-057-92	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-057-94	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-057-53	`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	67544-057-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-057-80	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-057-75	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-057-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-057-70	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-057-92	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-057-94	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-057-53	`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	67544-057-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67544-057-80	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67544-057-75	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67544-057-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67544-057-70	`302b2466d912…`	`e7b80fea0513…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
67544-057-30	PHENOBARBITAL TABLETS, USP CIV Rx only
67544-057-53	PHENOBARBITAL TABLETS, USP CIV Rx only
67544-057-60	PHENOBARBITAL TABLETS, USP CIV Rx only
67544-057-70	PHENOBARBITAL TABLETS, USP CIV Rx only
67544-057-75	PHENOBARBITAL TABLETS, USP CIV Rx only
67544-057-80	PHENOBARBITAL TABLETS, USP CIV Rx only
67544-057-92	PHENOBARBITAL TABLETS, USP CIV Rx only
67544-057-94	PHENOBARBITAL TABLETS, USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67544-057-30	Phenobarbital	30 in 1 BOTTLE, PLASTIC	TABLET	30	1
67544-057-53	Phenobarbital	60 in 1 BOTTLE, PLASTIC	TABLET	60	1
67544-057-60	Phenobarbital	90 in 1 BOTTLE, PLASTIC	TABLET	90	1
67544-057-70	Phenobarbital	120 in 1 BOTTLE, PLASTIC	TABLET	120	1
67544-057-75	Phenobarbital	150 in 1 BOTTLE, PLASTIC	TABLET	150	1
67544-057-80	Phenobarbital	180 in 1 BOTTLE, PLASTIC	TABLET	180	1
67544-057-92	Phenobarbital	270 in 1 BOTTLE, PLASTIC	TABLET	270	1
67544-057-94	Phenobarbital	360 in 1 BOTTLE, PLASTIC	TABLET	360	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67544-057-30	EA - Each	67544-057	dbbfd132-3e53-4327-9e7a-b3d0da8b688b	1	2013-07-02
67544-057-53	EA - Each	67544-057	aef23bc4-6148-41df-a1f3-24c6ebdfcb75	1	2013-06-04
67544-057-60	EA - Each	67544-057	80d103ef-2e9b-451c-8199-d0c391f334df	1	2013-06-04
67544-057-70	EA - Each	67544-057	44d2d84c-0a07-4e1c-8f49-4503a9d7f8ed	1	2013-06-04
67544-057-75	EA - Each	67544-057	5fc02b41-e44a-4134-8b78-6449783c3462	1	2013-06-04
67544-057-80	EA - Each	67544-057	2d06871e-2b02-467b-998a-da114007526b	1	2013-06-04
67544-057-92	EA - Each	67544-057	825d7617-e5bc-43e2-9753-31000f8a1f35	1	2013-07-02
67544-057-94	EA - Each	67544-057	2afa89ee-0e22-4301-a5bf-a01602ce70a2	1	2013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENOBARBITAL	ACTIVE INGREDIENT	YQE403BP4D	PHENOBARBITAL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
PHENOBARBITAL	ACTIVE MOIETY	YQE403BP4D	PHENOBARBITAL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PHENOBARBITAL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PHENOBARBITAL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENOBARBITAL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PHENOBARBITAL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PHENOBARBITAL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67544-057	PHENOBARBITAL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1	Legacy NDC, 8 package rows	20130503_b07a9069-791b-4584-897c-873b8570b83e.zip

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
199167	PHENobarbital 32.4 MG Oral Tablet	PSN	b07a9069-791b-4584-897c-873b8570b83e	1
199167	phenobarbital 32.4 MG Oral Tablet	SCD	b07a9069-791b-4584-897c-873b8570b83e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
67544-057-30	67544005730	30 in 1 BOTTLE, PLASTIC	Historical
67544-057-53	67544005753	60 in 1 BOTTLE, PLASTIC	Historical
67544-057-60	67544005760	90 in 1 BOTTLE, PLASTIC	Historical
67544-057-70	67544005770	120 in 1 BOTTLE, PLASTIC	Historical
67544-057-75	67544005775	150 in 1 BOTTLE, PLASTIC	Historical
67544-057-80	67544005780	180 in 1 BOTTLE, PLASTIC	Historical
67544-057-92	67544005792	270 in 1 BOTTLE, PLASTIC	Historical
67544-057-94	67544005794	360 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PHENOBARBITAL TABLETS, USP CIV Rx only	Aphena Pharma Solutions - Tennessee, Inc.	2013-05-02	HUMAN PRESCRIPTION DRUG LABEL	1