FDA.reportPublic FDA data

Phenobarbital

Product NDC
63629-2404
11-digit product format
636292404
Labeler code
63629
Product ID
63629-2404_a448d660-e7c5-4d2d-993b-3b407b176ac9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-11-01
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199164Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a6ae0875-77dd-48a7-b1bd-dc6f6bd7b2abAvailable 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
63629-2404-1Phenobarbital100 in 1 BOTTLETABLET100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2404-1EA - Each63629-240401bed309-a06f-4dd6-a536-ef8f58efe57e12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2404PHENOBARBITAL TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240112_a6ae0875-77dd-48a7-b1bd-dc6f6bd7b2ab.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 Prepacka6ae0875-77dd-48a7-b1bd-dc6f6bd7b2ab2024-01-11Warnings, Adverse reactionsExact identifier
ndc (product): 63629-2404

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199164PHENobarbital 97.2 MG Oral TabletPSNa6ae0875-77dd-48a7-b1bd-dc6f6bd7b2ab102
199164phenobarbital 97.2 MG Oral TabletSCDa6ae0875-77dd-48a7-b1bd-dc6f6bd7b2ab102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2404-163629240401100 TABLET in 1 BOTTLE (63629-2404-1) 100 tablet2021-02-230000-00-00NoNoCurrent