FDA.reportPublic FDA data

Phenobarbital

Product NDC
54932-501
Requested package NDC
54932-501-81
11-digit product format
549320501
Labeler code
54932
Product ID
54932-501_f67efa31-1709-42b3-ae74-4638dbbb1a1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
LIQUID
Route
ORAL
Labeler
BioRamo, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2019-03-29
Marketing end
0000-00-00
Substance
PHENOBARBITAL
Active strength
20 mg/5mL
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage54932-50154932-501-81IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e3e67a66-d325-4d80-8f9d-059e736d7b00Product name120230912
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54932-501-812022-03-29C16284748780-1d6a99b39-ed39-a426-e053-dadaa90af4c2PHENOBARBITAL ORAL SOLUTION, USP CIV
54932-501-812022-01-28C16284748780-1d6a99b39-ed39-a426-e053-dadaa90af4c2PHENOBARBITAL ORAL SOLUTION, USP CIV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54932-501-81Phenobarbital473 mL in 1 BOTTLELIQUID4734

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54932-501-81ML - Milliliter54932-50162b5aecd-f719-4aea-80f8-d243f725f1dc12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54932-501PHENOBARBITAL LIQUID [BIORAMO, LLC]4Legacy NDC, 1 package rows20241220_0c810ed3-597c-4d2b-957f-5b9acb253d5c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702519PHENobarbital 20 MG in 5 mL Oral SolutionPSN0c810ed3-597c-4d2b-957f-5b9acb253d5c4
702519phenobarbital 4 MG/ML Oral SolutionSCD0c810ed3-597c-4d2b-957f-5b9acb253d5c4
702519phenobarbital 20 MG per 5 ML Oral SolutionSY0c810ed3-597c-4d2b-957f-5b9acb253d5c4
702519phenobarbital 30 MG per 7.5 ML Oral SolutionSY0c810ed3-597c-4d2b-957f-5b9acb253d5c4
702519phenobarbital 60 MG per 15 ML Oral SolutionSY0c810ed3-597c-4d2b-957f-5b9acb253d5c4
702519PHENobarbital 20 MG in 5 mL Oral SolutionPSN4471a8de-d6c1-489a-a717-9a2bbcc51b153
702519phenobarbital 4 MG/ML Oral SolutionSCD4471a8de-d6c1-489a-a717-9a2bbcc51b153
702519phenobarbital 20 MG per 5 ML Oral SolutionSY4471a8de-d6c1-489a-a717-9a2bbcc51b153
702519phenobarbital 30 MG per 7.5 ML Oral SolutionSY4471a8de-d6c1-489a-a717-9a2bbcc51b153
702519phenobarbital 60 MG per 15 ML Oral SolutionSY4471a8de-d6c1-489a-a717-9a2bbcc51b153
702519PHENobarbital 20 MG in 5 mL Oral SolutionPSN1fc1d779-7dd5-4f98-be67-a5ab710faf691
702519phenobarbital 4 MG/ML Oral SolutionSCD1fc1d779-7dd5-4f98-be67-a5ab710faf691
702519phenobarbital 20 MG per 5 ML Oral SolutionSY1fc1d779-7dd5-4f98-be67-a5ab710faf691
702519phenobarbital 30 MG per 7.5 ML Oral SolutionSY1fc1d779-7dd5-4f98-be67-a5ab710faf691
702519phenobarbital 60 MG per 15 ML Oral SolutionSY1fc1d779-7dd5-4f98-be67-a5ab710faf691

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54932-501-8154932050181473 mL in 1 BOTTLE (54932-501-81) 473 ml2019-03-290000-00-00NoNoCurrent