FDA.reportPublic FDA data

Phenobarbital

Product NDC
0603-5165
11-digit product format
006035165
Labeler code
0603
Product ID
0603-5165_f8c5136e-e35c-4425-8d49-b7f92c827b42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
Par Health USA, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2002-03-01
Marketing end
2027-01-31
Substance
PHENOBARBITAL
Active strength
16.2 mg/1
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0603-51650603-5165-32DDiscontinued by firm2026-08-17

Additional Listing Data#

Finished product
Yes
Brand name base
Phenobarbital

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOBARBITAL16.2 mg/1

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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198086Internal RxNorm lookup
199164Internal RxNorm lookup
199167Internal RxNorm lookup
199168Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
069b92ce-0061-4724-8c25-08d8596770a2Available 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
0603-5165-21Phenobarbital100 in 1 BOTTLE, PLASTICTABLET10013
0603-5165-32Phenobarbital1000 in 1 BOTTLE, PLASTICTABLET100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-5165-21EA - Each0603-516523fee4d4-52d7-4206-854d-39ac9e8ca36312012-07-24
0603-5165-32EA - Each0603-51659eb724f5-a82e-4350-9cbc-aa11d17b769712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENOBARBITALACTIVE INGREDIENTYQE403BP4DPHENOBARBITAL TABLET [QUALITEST PHARMACEUTICALS]6
PHENOBARBITALACTIVE MOIETYYQE403BP4DPHENOBARBITAL TABLET [QUALITEST PHARMACEUTICALS]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENOBARBITAL TABLET [QUALITEST PHARMACEUTICALS]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENOBARBITAL TABLET [QUALITEST PHARMACEUTICALS]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENOBARBITAL TABLET [QUALITEST PHARMACEUTICALS]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENOBARBITAL TABLET [QUALITEST PHARMACEUTICALS]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PHENOBARBITAL TABLET [QUALITEST PHARMACEUTICALS]6
PHENOBARBITALACTIVE INGREDIENTYQE403BP4DPHENOBARBITAL TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2
PHENOBARBITALACTIVE MOIETYYQE403BP4DPHENOBARBITAL TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENOBARBITAL TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENOBARBITAL TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENOBARBITAL TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENOBARBITAL TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PHENOBARBITAL TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0603-5165PHENOBARBITAL TABLET [ENDO USA, INC.]12Current NDC, Legacy NDC, 2 package rows20240913_069b92ce-0061-4724-8c25-08d8596770a2.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
PhenobarbitalPHENOBARBITALPar Health USA, LLC069b92ce-0061-4724-8c25-08d8596770a22024-08-20Warnings, Adverse reactionsExact identifier
ndc (product): 0603-5165

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198086PHENobarbital 16.2 MG Oral TabletPSNb53fc65c-02f2-4a77-914c-8f2c78fca546103
198086phenobarbital 16.2 MG Oral TabletSCDb53fc65c-02f2-4a77-914c-8f2c78fca546103
198086PHENobarbital 16.2 MG Oral TabletPSNf85515e4-06cf-42d7-8e3e-066874787a04101
198086phenobarbital 16.2 MG Oral TabletSCDf85515e4-06cf-42d7-8e3e-066874787a04101
198086PHENobarbital 16.2 MG Oral TabletPSN069b92ce-0061-4724-8c25-08d8596770a213
199167PHENobarbital 32.4 MG Oral TabletPSN069b92ce-0061-4724-8c25-08d8596770a213
199168PHENobarbital 64.8 MG Oral TabletPSN069b92ce-0061-4724-8c25-08d8596770a213
199164PHENobarbital 97.2 MG Oral TabletPSN069b92ce-0061-4724-8c25-08d8596770a213
198086phenobarbital 16.2 MG Oral TabletSCD069b92ce-0061-4724-8c25-08d8596770a213
199167phenobarbital 32.4 MG Oral TabletSCD069b92ce-0061-4724-8c25-08d8596770a213
199168phenobarbital 64.8 MG Oral TabletSCD069b92ce-0061-4724-8c25-08d8596770a213
199164phenobarbital 97.2 MG Oral TabletSCD069b92ce-0061-4724-8c25-08d8596770a213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0603-5165-2100603516521100 TABLET in 1 BOTTLE, PLASTIC (0603-5165-21) 100 tablet2002-03-012027-01-31NoNoCurrent
0603-5165-32006035165321000 TABLET in 1 BOTTLE, PLASTIC (0603-5165-32) 1000 tablet2002-03-012026-05-31NoNoCurrent