FDA.reportPublic FDA data

Phenobarbital

Product NDC
13811-301
11-digit product format
138110301
Labeler code
13811
Product ID
13811-301_d257e8d3-1dae-4059-b11f-711709b6b4c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
Trigen Laboratories, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-04-01
Substance
PHENOBARBITAL
Active strength
30 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOBARBITAL30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YQE403BP4DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198083Internal RxNorm lookup
198089Internal RxNorm lookup
312357Internal RxNorm lookup
312362Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b159d42e-c2f5-4611-89b4-3477347a08d7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e3e67a66-d325-4d80-8f9d-059e736d7b00Product name120230912

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13811-301-10Phenobarbital100 in 1 BOTTLE, PLASTICTABLET1003
13811-301-50Phenobarbital500 in 1 BOTTLE, PLASTICTABLET5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13811-301-10EA - Each13811-30131cb3ae4-cf09-4eb8-8b49-4d341343b69b12025-05-14
13811-301-50EA - Each13811-3015c9decaf-a31c-4197-84d9-a30d15a082fc12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13811-301PHENOBARBITAL TABLET [TRIGEN LABORATORIES, LLC]2Current NDC, 2 package rows20250403_b159d42e-c2f5-4611-89b4-3477347a08d7.zip

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PhenobarbitalPHENOBARBITALTrigen Laboratories, LLCb159d42e-c2f5-4611-89b4-3477347a08d72025-09-22Warnings, Adverse reactionsExact identifier
ndc (product): 13811-301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198083PHENobarbital 100 MG Oral TabletPSNb159d42e-c2f5-4611-89b4-3477347a08d73
312357PHENobarbital 15 MG Oral TabletPSNb159d42e-c2f5-4611-89b4-3477347a08d73
312362PHENobarbital 30 MG Oral TabletPSNb159d42e-c2f5-4611-89b4-3477347a08d73
198089PHENobarbital 60 MG Oral TabletPSNb159d42e-c2f5-4611-89b4-3477347a08d73
198083phenobarbital 100 MG Oral TabletSCDb159d42e-c2f5-4611-89b4-3477347a08d73
312357phenobarbital 15 MG Oral TabletSCDb159d42e-c2f5-4611-89b4-3477347a08d73
312362phenobarbital 30 MG Oral TabletSCDb159d42e-c2f5-4611-89b4-3477347a08d73
198089phenobarbital 60 MG Oral TabletSCDb159d42e-c2f5-4611-89b4-3477347a08d73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13811-301-1013811030110100 TABLET in 1 BOTTLE, PLASTIC (13811-301-10) 100 tablet2025-04-01NoNoCurrent
13811-301-5013811030150500 TABLET in 1 BOTTLE, PLASTIC (13811-301-50) 500 tablet2025-04-01NoNoCurrent