FDA.reportPublic FDA data

Phenobarbital Oral Solution

Product NDC
82983-417
Requested package NDC
82983-417-47
11-digit product format
829830417
Labeler code
82983
Product ID
82983-417_92c0898e-5e8a-448e-8dfc-f944d12a637a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital Oral
Dosage form
SOLUTION
Route
ORAL
Labeler
Ajenat Pharmaceuticals LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-11-05
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 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
adf9382d-9fa3-4574-bfcd-e92a8b3433e6Available 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
82983-417-47Phenobarbital Oral Solution473 mL in 1 BOTTLE, PLASTICSOLUTION4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82983-417-47ML - Milliliter82983-41777b1a7b4-711f-4673-b537-b482adf7ce9712026-01-08

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 ORALAjenat Pharmaceuticals LLCadf9382d-9fa3-4574-bfcd-e92a8b3433e62025-12-29Warnings, Adverse reactionsExact identifier
ndc (package): 82983-417-47
ndc (product): 82983-417
ndc11 (package): 82983041747

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702519PHENobarbital 20 MG in 5 mL Oral SolutionPSNadf9382d-9fa3-4574-bfcd-e92a8b3433e62
702519phenobarbital 4 MG/ML Oral SolutionSCDadf9382d-9fa3-4574-bfcd-e92a8b3433e62
702519phenobarbital 20 MG per 5 ML Oral SolutionSYadf9382d-9fa3-4574-bfcd-e92a8b3433e62
702519phenobarbital 30 MG per 7.5 ML Oral SolutionSYadf9382d-9fa3-4574-bfcd-e92a8b3433e62
702519phenobarbital 60 MG per 15 ML Oral SolutionSYadf9382d-9fa3-4574-bfcd-e92a8b3433e62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82983-417-4782983041747473 mL in 1 BOTTLE, PLASTIC (82983-417-47) 473 ml2025-11-05NoNoCurrent