FDA.reportPublic FDA data

Phenobarbital

Product NDC
64380-166
11-digit product format
643800166
Labeler code
64380
Product ID
64380-166_fac9083b-0b86-4d8d-b843-25f74f217e15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenobarbital
Dosage form
ELIXIR
Route
ORAL
Labeler
Strides Pharma Science Limited
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-04-04
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
b3ed0ef0-41de-46b1-af5f-4b940e74921bAvailable 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
64380-166-01Phenobarbital473 mL in 1 BOTTLE, PLASTICELIXIR4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-166-01ML - Milliliter64380-1661e2826a5-18cb-4d61-8fc1-41a1b4fe359612022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-166PHENOBARBITAL ELIXIR [STRIDES PHARMA SCIENCE LIMITED]2Current NDC, Legacy NDC, 1 package rows20220404_b3ed0ef0-41de-46b1-af5f-4b940e74921b.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
PhenobarbitalPHENOBARBITALStrides Pharma Science Limitedb3ed0ef0-41de-46b1-af5f-4b940e74921b2022-04-06Warnings, Adverse reactionsExact identifier
ndc (product): 64380-166

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
702519PHENobarbital 20 MG in 5 mL Oral SolutionPSNb3ed0ef0-41de-46b1-af5f-4b940e74921b2
702519phenobarbital 4 MG/ML Oral SolutionSCDb3ed0ef0-41de-46b1-af5f-4b940e74921b2
702519phenobarbital 20 MG per 5 ML Oral SolutionSYb3ed0ef0-41de-46b1-af5f-4b940e74921b2
702519phenobarbital 30 MG per 7.5 ML Oral SolutionSYb3ed0ef0-41de-46b1-af5f-4b940e74921b2
702519phenobarbital 60 MG per 15 ML Oral SolutionSYb3ed0ef0-41de-46b1-af5f-4b940e74921b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-166-0164380016601473 mL in 1 BOTTLE, PLASTIC (64380-166-01) 473 ml2022-04-040000-00-00NoNoCurrent