FDA.reportPublic FDA data

Phenobarbital

Product NDC
63629-2289
11-digit product format
636292289
Labeler code
63629
Product ID
63629-2289_7fb89656-6d68-4943-b682-7df5b242c49b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2002-03-01
Substance
PHENOBARBITAL
Active strength
16.2 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
PHENOBARBITAL16.2 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198086Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b53fc65c-02f2-4a77-914c-8f2c78fca546Available 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
63629-2289-1Phenobarbital1000 in 1 BOTTLE, PLASTICTABLET1000103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2289-1EA - Each63629-2289b129909e-1431-4d3f-978e-5814738c25da12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2289PHENOBARBITAL TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20241023_b53fc65c-02f2-4a77-914c-8f2c78fca546.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
PhenobarbitalPHENOBARBITALBryant Ranch Prepackb53fc65c-02f2-4a77-914c-8f2c78fca5462024-10-10Warnings, Adverse reactionsExact identifier
ndc (product): 63629-2289

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198086PHENobarbital 16.2 MG Oral TabletPSNb53fc65c-02f2-4a77-914c-8f2c78fca546103
198086phenobarbital 16.2 MG Oral TabletSCDb53fc65c-02f2-4a77-914c-8f2c78fca546103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2289-1636292289011000 TABLET in 1 BOTTLE, PLASTIC (63629-2289-1) 1000 tablet2002-03-010000-00-00NoNoCurrent