FDA.reportPublic FDA data

Phenobarbital

Product NDC
63187-895
11-digit product format
631870895
Labeler code
63187
Product ID
63187-895_581223b4-bbec-4e9b-9e86-4749c0b28c42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2003-02-01
Substance
PHENOBARBITAL
Active strength
32.4 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
PHENOBARBITAL32.4 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199167Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e1756186-6b8c-4965-bfa7-9d5fad3421abAvailable 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
63187-895-30Phenobarbital30 in 1 BOTTLE, PLASTICTABLET303
63187-895-60Phenobarbital60 in 1 BOTTLE, PLASTICTABLET603
63187-895-90Phenobarbital90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-895-90EA - Each63187-895bff13859-b49d-4c56-bcf8-4bacbbdaae7212017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-895PHENOBARBITAL TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20191108_e1756186-6b8c-4965-bfa7-9d5fad3421ab.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
PhenobarbitalPHENOBARBITALProficient Rx LPe1756186-6b8c-4965-bfa7-9d5fad3421ab2019-11-01Warnings, Adverse reactionsExact identifier
ndc (product): 63187-895

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199167PHENobarbital 32.4 MG Oral TabletPSNe1756186-6b8c-4965-bfa7-9d5fad3421ab3
199167phenobarbital 32.4 MG Oral TabletSCDe1756186-6b8c-4965-bfa7-9d5fad3421ab3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-895-306318708953030 TABLET in 1 BOTTLE, PLASTIC (63187-895-30) 30 tablet2017-08-010000-00-00NoNoCurrent
63187-895-606318708956060 TABLET in 1 BOTTLE, PLASTIC (63187-895-60) 60 tablet2017-08-010000-00-00NoNoCurrent
63187-895-906318708959090 TABLET in 1 BOTTLE, PLASTIC (63187-895-90) 90 tablet2017-08-010000-00-00NoNoCurrent