FDA.reportPublic FDA data

Phenobarbital

Product NDC
68999-962
Requested package NDC
68999-962-24
11-digit product format
689990962
Labeler code
68999
Product ID
68999-962_4ba9b27e-0ef4-ea4c-e063-6394a90ab84a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell Governmental & Specialty RX, LLC.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-02-13
Substance
PHENOBARBITAL
Active strength
20 mg/5mL
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
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
2027-12-31

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
4616303e-1d91-4888-8156-4ae6bd3891b7Available 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
68999-962-05Phenobarbital5 mL in 1 CUPSOLUTION52
68999-962-07Phenobarbital7.5 mL in 1 CUPSOLUTION7.52
68999-962-15Phenobarbital15 mL in 1 CUPSOLUTION152
68999-962-22Phenobarbital10 in 1 TRAYSOLUTION102
68999-962-22Phenobarbital2 in 1 BOXSOLUTION22
68999-962-23Phenobarbital10 in 1 TRAYSOLUTION102
68999-962-23Phenobarbital2 in 1 BOXSOLUTION22
68999-962-24Phenobarbital2 in 1 BOXSOLUTION22
68999-962-24Phenobarbital10 in 1 TRAYSOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68999-962-05ML - Milliliter68999-962e01fa165-eea6-4ab1-8459-d0eafed341a312026-04-20
68999-962-07ML - Milliliter68999-962eb93f3e3-e30e-4c36-b648-cbbfeb21804f12026-04-20
68999-962-15ML - Milliliter68999-962962e14d6-a27c-425a-9c22-21e623b87d6312026-04-20
68999-962-22ML - Milliliter68999-962d209fbae-4cd7-4b53-b72d-1d1d471bad1712026-04-20
68999-962-23ML - Milliliter68999-9628e09e350-614e-4f82-bcf5-f55cd8b7aa6e12026-04-20
68999-962-24ML - Milliliter68999-962de43f0f5-ee22-4a2e-a130-4863f16c7e8d12026-04-20

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
PhenobarbitalPHENOBARBITALChartwell Governmental & Specialty RX, LLC.4616303e-1d91-4888-8156-4ae6bd3891b72026-02-25Warnings, Adverse reactionsExact identifier
ndc (package): 68999-962-24
ndc (product): 68999-962
ndc11 (package): 68999096224

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702519PHENobarbital 20 MG in 5 mL Oral SolutionPSN4616303e-1d91-4888-8156-4ae6bd3891b72
702519phenobarbital 4 MG/ML Oral SolutionSCD4616303e-1d91-4888-8156-4ae6bd3891b72
702519phenobarbital 20 MG per 5 ML Oral SolutionSY4616303e-1d91-4888-8156-4ae6bd3891b72
702519phenobarbital 30 MG per 7.5 ML Oral SolutionSY4616303e-1d91-4888-8156-4ae6bd3891b72
702519phenobarbital 60 MG per 15 ML Oral SolutionSY4616303e-1d91-4888-8156-4ae6bd3891b72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68999-962-24689990962242 TRAY in 1 BOX (68999-962-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-962-05) 2 tray2026-02-17NoNoCurrent