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 Identifiers#

Field, Values table
FieldValues
UniiYQE403BP4D
Rxcui702519

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

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