FDA.reportPublic FDA data

PHENOBARBITAL

Product NDC
64950-578
11-digit product format
649500578
Labeler code
64950
Product ID
64950-578_ec88f9c0-b075-49a7-acda-8dc7a84b2aee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENOBARBITAL
Dosage form
TABLET
Route
ORAL
Labeler
Genus Lifesciences
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-03-01
Substance
PHENOBARBITAL
Active strength
100 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PHENOBARBITAL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOBARBITAL100 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 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198083Internal RxNorm lookup
198086Internal RxNorm lookup
198089Internal RxNorm lookup
199164Internal RxNorm lookup
199167Internal RxNorm lookup
199168Internal 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
074e875d-474a-4bbc-9008-821d63ca9e32Available 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
64950-578-01PHENOBARBITAL100 in 1 BOTTLETABLET1002
64950-578-10PHENOBARBITAL1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64950-578-01EA - Each64950-57896919fa2-b64d-4ac6-b830-fb0d9fd980f612025-05-14
64950-578-10EA - Each64950-57855552856-5c57-46b9-8722-05ea30f0a5db12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64950-578PHENOBARBITAL TABLET [GENUS LIFESCIENCES]1Current NDC, 2 package rows20250305_074e875d-474a-4bbc-9008-821d63ca9e32.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
PHENOBARBITALPHENOBARBITALGenus Lifesciences074e875d-474a-4bbc-9008-821d63ca9e322026-04-17Warnings, Adverse reactionsExact identifier
ndc (product): 64950-578

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198083PHENobarbital 100 MG Oral TabletPSN074e875d-474a-4bbc-9008-821d63ca9e322
312357PHENobarbital 15 MG Oral TabletPSN074e875d-474a-4bbc-9008-821d63ca9e322
198086PHENobarbital 16.2 MG Oral TabletPSN074e875d-474a-4bbc-9008-821d63ca9e322
312362PHENobarbital 30 MG Oral TabletPSN074e875d-474a-4bbc-9008-821d63ca9e322
199167PHENobarbital 32.4 MG Oral TabletPSN074e875d-474a-4bbc-9008-821d63ca9e322
198089PHENobarbital 60 MG Oral TabletPSN074e875d-474a-4bbc-9008-821d63ca9e322
199168PHENobarbital 64.8 MG Oral TabletPSN074e875d-474a-4bbc-9008-821d63ca9e322
199164PHENobarbital 97.2 MG Oral TabletPSN074e875d-474a-4bbc-9008-821d63ca9e322
198083phenobarbital 100 MG Oral TabletSCD074e875d-474a-4bbc-9008-821d63ca9e322
312357phenobarbital 15 MG Oral TabletSCD074e875d-474a-4bbc-9008-821d63ca9e322
198086phenobarbital 16.2 MG Oral TabletSCD074e875d-474a-4bbc-9008-821d63ca9e322
312362phenobarbital 30 MG Oral TabletSCD074e875d-474a-4bbc-9008-821d63ca9e322
199167phenobarbital 32.4 MG Oral TabletSCD074e875d-474a-4bbc-9008-821d63ca9e322
198089phenobarbital 60 MG Oral TabletSCD074e875d-474a-4bbc-9008-821d63ca9e322
199168phenobarbital 64.8 MG Oral TabletSCD074e875d-474a-4bbc-9008-821d63ca9e322
199164phenobarbital 97.2 MG Oral TabletSCD074e875d-474a-4bbc-9008-821d63ca9e322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64950-578-0164950057801100 TABLET in 1 BOTTLE (64950-578-01) 100 tablet2025-03-01NoNoCurrent
64950-578-10649500578101000 TABLET in 1 BOTTLE (64950-578-10) 1000 tablet2025-03-01NoNoCurrent