Phenobarbital

Product NDC: 67046-1434
Requested package NDC: 67046-1434-3
11-digit product format: 670461434
Labeler code: 67046
Product ID: 67046-1434_38f737f8-385d-f2b6-e063-6394a90ac88d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenobarbital
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2025-07-02
Substance: PHENOBARBITAL
Active strength: 64.8 mg/1
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Phenobarbital
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENOBARBITAL	64.8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
YQE403BP4D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199168	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
38f738a5-1c2f-b404-e063-6294a90a9879	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67046-1434-3	Phenobarbital	30 in 1 BLISTER PACK	TABLET	30		1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenobarbital	PHENOBARBITAL	Coupler LLC	38f738a5-1c2f-b404-e063-6294a90a9879	2025-07-02	Warnings, Adverse reactions	Exact identifier ndc (package): 67046-1434-3 ndc (product): 67046-1434 ndc11 (package): 67046143403

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
199168	PHENobarbital 64.8 MG Oral Tablet	PSN	38f738a5-1c2f-b404-e063-6294a90a9879	1
199168	phenobarbital 64.8 MG Oral Tablet	SCD	38f738a5-1c2f-b404-e063-6294a90a9879	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-1434-3	67046143403	30 TABLET in 1 BLISTER PACK (67046-1434-3)	30 tablet	2025-07-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PHENOBARBITAL TABLETS, USP CIV Rx Only Rev. Jan 2022	Coupler LLC	2025-07-02	HUMAN PRESCRIPTION DRUG LABEL	1