Phenobarbital Oral Solution

Product NDC
54288-163
11-digit product format
542880163
Labeler code
54288
Product ID
54288-163_7c47a17d-2865-4db3-856d-5b283b8eae21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital Oral
Dosage form
SOLUTION
Route
ORAL
Labeler
BPI Labs LLC
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 Identifiers#

Field, Values table
FieldValues
UniiYQE403BP4D
Rxcui702519

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e3e67a66-d325-4d80-8f9d-059e736d7b00Product name120230912

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54288-163-47Phenobarbital Oral Solution473 mL in 1 BOTTLE, PLASTICSOLUTION4733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54288-163PHENOBARBITAL ORAL SOLUTION (PHENOBARBITAL ORAL) SOLUTION [BPI LABS LLC]2Current NDC, 1 package rows20250213_45f6317e-cfc9-4ec9-84c9-72daa6c68911.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702519PHENobarbital 20 MG in 5 mL Oral SolutionPSN45f6317e-cfc9-4ec9-84c9-72daa6c689113
702519phenobarbital 4 MG/ML Oral SolutionSCD45f6317e-cfc9-4ec9-84c9-72daa6c689113
702519phenobarbital 20 MG per 5 ML Oral SolutionSY45f6317e-cfc9-4ec9-84c9-72daa6c689113
702519phenobarbital 30 MG per 7.5 ML Oral SolutionSY45f6317e-cfc9-4ec9-84c9-72daa6c689113
702519phenobarbital 60 MG per 15 ML Oral SolutionSY45f6317e-cfc9-4ec9-84c9-72daa6c689113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54288-163-4754288016347473 mL in 1 BOTTLE, PLASTIC (54288-163-47) 473 ml2023-10-27NoNoCurrent