FDA.reportPublic FDA data

Phenobarbital

Product NDC
13811-307
11-digit product format
138110307
Labeler code
13811
Product ID
13811-307_e0527225-8681-4a9c-8b5c-2681579f4115
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
97.2 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
PHENOBARBITAL97.2 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
198086Internal RxNorm lookup
199164Internal RxNorm lookup
199167Internal RxNorm lookup
199168Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5d1f0f48-06d9-4408-b9a2-60d7a09d942fAvailable 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
13811-307-10Phenobarbital100 in 1 BOTTLE, PLASTICTABLET1003
13811-307-52Phenobarbital1000 in 1 BOTTLE, PLASTICTABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13811-307-10EA - Each13811-30750742bf9-1bdc-41b2-9020-2bd14ec62aa312025-05-14
13811-307-52EA - Each13811-3070ffa094b-1f51-4369-b173-9624b6ac6cc912025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13811-307PHENOBARBITAL TABLET [TRIGEN LABORATORIES, LLC]2Current NDC, 2 package rows20250403_5d1f0f48-06d9-4408-b9a2-60d7a09d942f.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, LLC5d1f0f48-06d9-4408-b9a2-60d7a09d942f2025-09-22Warnings, Adverse reactionsExact identifier
ndc (product): 13811-307

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198086PHENobarbital 16.2 MG Oral TabletPSN5d1f0f48-06d9-4408-b9a2-60d7a09d942f3
199167PHENobarbital 32.4 MG Oral TabletPSN5d1f0f48-06d9-4408-b9a2-60d7a09d942f3
199168PHENobarbital 64.8 MG Oral TabletPSN5d1f0f48-06d9-4408-b9a2-60d7a09d942f3
199164PHENobarbital 97.2 MG Oral TabletPSN5d1f0f48-06d9-4408-b9a2-60d7a09d942f3
198086phenobarbital 16.2 MG Oral TabletSCD5d1f0f48-06d9-4408-b9a2-60d7a09d942f3
199167phenobarbital 32.4 MG Oral TabletSCD5d1f0f48-06d9-4408-b9a2-60d7a09d942f3
199168phenobarbital 64.8 MG Oral TabletSCD5d1f0f48-06d9-4408-b9a2-60d7a09d942f3
199164phenobarbital 97.2 MG Oral TabletSCD5d1f0f48-06d9-4408-b9a2-60d7a09d942f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13811-307-1013811030710100 TABLET in 1 BOTTLE, PLASTIC (13811-307-10) 100 tablet2025-04-01NoNoCurrent
13811-307-52138110307521000 TABLET in 1 BOTTLE, PLASTIC (13811-307-52) 1000 tablet2025-04-01NoNoCurrent