FDA.reportPublic FDA data

Phenobarbital

Product NDC
60687-671
11-digit product format
606870671
Labeler code
60687
Product ID
60687-671_39982124-4de4-f29b-e063-6394a90a337a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenobarbital
Dosage form
ELIXIR
Route
ORAL
Labeler
American Health Packaging
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-12-19
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
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
26d326a4-9bb1-4c52-a1d1-74629d97c433Available 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
60687-671-40Phenobarbital5 mL in 1 CUP, UNIT-DOSEELIXIR53
60687-671-46Phenobarbital10 in 1 TRAYELIXIR103
60687-671-67Phenobarbital5 in 1 CASEELIXIR53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-671-40ML - Milliliter60687-671bd55f6ab-2b65-4019-8250-ec60bc5efef312022-11-07
60687-671-46ML - Milliliter60687-67131c2d7fc-4182-47eb-a559-31585b3beed512022-11-07
60687-671-67ML - Milliliter60687-6711f281ca2-26e5-419c-8451-01ce846815e812022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-671PHENOBARBITAL ELIXIR [AMERICAN HEALTH PACKAGING]2Current NDC, Legacy NDC, 3 package rows20230301_26d326a4-9bb1-4c52-a1d1-74629d97c433.zip

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
PhenobarbitalPHENOBARBITALAmerican Health Packaging26d326a4-9bb1-4c52-a1d1-74629d97c4332025-07-10Warnings, Adverse reactionsExact identifier
ndc (product): 60687-671

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702519PHENobarbital 20 MG in 5 mL Oral SolutionPSN26d326a4-9bb1-4c52-a1d1-74629d97c4333
702519phenobarbital 4 MG/ML Oral SolutionSCD26d326a4-9bb1-4c52-a1d1-74629d97c4333
702519phenobarbital 20 MG per 5 ML Oral SolutionSY26d326a4-9bb1-4c52-a1d1-74629d97c4333
702519phenobarbital 30 MG per 7.5 ML Oral SolutionSY26d326a4-9bb1-4c52-a1d1-74629d97c4333
702519phenobarbital 60 MG per 15 ML Oral SolutionSY26d326a4-9bb1-4c52-a1d1-74629d97c4333

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-671-40606870671405 mL in 1 CUP, UNIT-DOSE5 mlHistorical
60687-671-466068706714610 in 1 TRAYHistorical
60687-671-67606870671675 TRAY in 1 CASE (60687-671-67) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-671-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-671-40) 5 tray2022-12-190000-00-00NoNoCurrent