FDA.reportPublic FDA data

Phenobarbital

Product NDC
16571-674
11-digit product format
165710674
Labeler code
16571
Product ID
16571-674_e81ffc2f-9aa0-4b68-9d42-63d23dc30824
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-11-01
Substance
PHENOBARBITAL
Active strength
60 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
PHENOBARBITAL60 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
e81ffc2f-9aa0-4b68-9d42-63d23dc30824Available 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
16571-674-01Phenobarbital100 in 1 BOTTLETABLET1001
16571-674-10Phenobarbital1000 in 1 BOTTLETABLET10001
16571-674-50Phenobarbital500 in 1 BOTTLETABLET5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-674PHENOBARBITAL TABLET [RISING PHARMA HOLDINGS, INC.]1Current NDC, Legacy NDC, 3 package rows20201117_e81ffc2f-9aa0-4b68-9d42-63d23dc30824.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
PhenobarbitalPHENOBARBITALRising Pharma Holdings, Inc.e81ffc2f-9aa0-4b68-9d42-63d23dc308242020-07-01Warnings, Adverse reactionsExact identifier
ndc (product): 16571-674

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198083PHENobarbital 100 MG Oral TabletPSN6cf88fef-0c82-4d5d-85e8-5896ac0131651
198083PHENobarbital 100 MG Oral TabletPSNe81ffc2f-9aa0-4b68-9d42-63d23dc308241
312357PHENobarbital 15 MG Oral TabletPSN6cf88fef-0c82-4d5d-85e8-5896ac0131651
312357PHENobarbital 15 MG Oral TabletPSNe81ffc2f-9aa0-4b68-9d42-63d23dc308241
312362PHENobarbital 30 MG Oral TabletPSNe81ffc2f-9aa0-4b68-9d42-63d23dc308241
198089PHENobarbital 60 MG Oral TabletPSN6cf88fef-0c82-4d5d-85e8-5896ac0131651
198089PHENobarbital 60 MG Oral TabletPSNe81ffc2f-9aa0-4b68-9d42-63d23dc308241
198083phenobarbital 100 MG Oral TabletSCD6cf88fef-0c82-4d5d-85e8-5896ac0131651
198083phenobarbital 100 MG Oral TabletSCDe81ffc2f-9aa0-4b68-9d42-63d23dc308241
312357phenobarbital 15 MG Oral TabletSCD6cf88fef-0c82-4d5d-85e8-5896ac0131651
312357phenobarbital 15 MG Oral TabletSCDe81ffc2f-9aa0-4b68-9d42-63d23dc308241
312362phenobarbital 30 MG Oral TabletSCDe81ffc2f-9aa0-4b68-9d42-63d23dc308241
198089phenobarbital 60 MG Oral TabletSCD6cf88fef-0c82-4d5d-85e8-5896ac0131651
198089phenobarbital 60 MG Oral TabletSCDe81ffc2f-9aa0-4b68-9d42-63d23dc308241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-674-0116571067401100 TABLET in 1 BOTTLE (16571-674-01) 100 tablet2020-11-010000-00-00NoNoCurrent
16571-674-10165710674101000 TABLET in 1 BOTTLE (16571-674-10) 1000 tablet2020-11-010000-00-00NoNoCurrent
16571-674-5016571067450500 TABLET in 1 BOTTLE (16571-674-50) 500 tablet2020-11-010000-00-00NoNoCurrent