FDA.reportPublic FDA data

Phenobarbital

Product NDC
63629-2399
11-digit product format
636292399
Labeler code
63629
Product ID
63629-2399_c99cdf38-8f11-4677-8219-392be12d33a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
LIQUID
Route
ORAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-09-01
Substance
PHENOBARBITAL
Active strength
20 mg/5mL
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Phenobarbital
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOBARBITAL20 mg/5mL

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
702519Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d16f6911-f218-41ab-86c6-f3cceaf315e3Available 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
63629-2399-1Phenobarbital473 mL in 1 BOTTLELIQUID473107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2399-1ML - Milliliter63629-239904afcf62-6fae-4936-b09a-f863fc91aca312021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2399PHENOBARBITAL LIQUID [BRYANT RANCH PREPACK]107Current NDC, Legacy NDC, 1 package rows20240821_d16f6911-f218-41ab-86c6-f3cceaf315e3.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 Prepackd16f6911-f218-41ab-86c6-f3cceaf315e32024-08-20Warnings, Adverse reactionsExact identifier
ndc (product): 63629-2399

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702519PHENobarbital 20 MG in 5 mL Oral SolutionPSNd16f6911-f218-41ab-86c6-f3cceaf315e3107
702519phenobarbital 4 MG/ML Oral SolutionSCDd16f6911-f218-41ab-86c6-f3cceaf315e3107
702519phenobarbital 20 MG per 5 ML Oral SolutionSYd16f6911-f218-41ab-86c6-f3cceaf315e3107
702519phenobarbital 30 MG per 7.5 ML Oral SolutionSYd16f6911-f218-41ab-86c6-f3cceaf315e3107
702519phenobarbital 60 MG per 15 ML Oral SolutionSYd16f6911-f218-41ab-86c6-f3cceaf315e3107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2399-163629239901473 mL in 1 BOTTLE (63629-2399-1) 473 ml2021-02-230000-00-00NoNoCurrent