FDA.reportPublic FDA data

Phenobarbital Oral Solution

Product NDC
81033-163
11-digit product format
810330163
Labeler code
81033
Product ID
81033-163_3deab1f7-df73-3253-e063-6394a90a6503
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital Oral
Dosage form
SOLUTION
Route
ORAL
Labeler
Kesin Pharma Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-10-27
Substance
PHENOBARBITAL
Active strength
20 mg/5mL
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 Oral Solution
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
3deab1d0-2201-41a6-e063-6394a90a5dc0Available 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
81033-163-05Phenobarbital Oral Solution5 mL in 1 CUP, UNIT-DOSESOLUTION51
81033-163-54Phenobarbital Oral Solution50 in 1 CARTONSOLUTION501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-163-05ML - Milliliter81033-163d65c8b0f-9319-45ad-b3a9-6ad37d11e95e12025-12-16
81033-163-54ML - Milliliter81033-16321e0be3f-5a8f-46e8-af84-aa657af8a4bb12025-12-16

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
Phenobarbital Oral SolutionPHENOBARBITAL ORALKesin Pharma Corporation3deab1d0-2201-41a6-e063-6394a90a5dc02025-09-03Warnings, Adverse reactionsExact identifier
ndc (product): 81033-163

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702519PHENobarbital 20 MG in 5 mL Oral SolutionPSN3deab1d0-2201-41a6-e063-6394a90a5dc01
702519phenobarbital 4 MG/ML Oral SolutionSCD3deab1d0-2201-41a6-e063-6394a90a5dc01
702519phenobarbital 20 MG per 5 ML Oral SolutionSY3deab1d0-2201-41a6-e063-6394a90a5dc01
702519phenobarbital 30 MG per 7.5 ML Oral SolutionSY3deab1d0-2201-41a6-e063-6394a90a5dc01
702519phenobarbital 60 MG per 15 ML Oral SolutionSY3deab1d0-2201-41a6-e063-6394a90a5dc01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-163-05810330163055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
81033-163-548103301635450 CUP, UNIT-DOSE in 1 CARTON (81033-163-54) / 5 mL in 1 CUP, UNIT-DOSE (81033-163-05) 2025-09-03NoNoCurrent