FDA.reportPublic FDA data

Phenobarbital

Product NDC
0143-1500
11-digit product format
001431500
Labeler code
0143
Product ID
0143-1500_3ccf4b4a-2458-4ea0-8feb-8f3ff9980bb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-03-05
Substance
PHENOBARBITAL
Active strength
30 mg/1
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
PHENOBARBITAL30 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
198083Internal RxNorm lookup
198089Internal RxNorm lookup
312357Internal RxNorm lookup
312362Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8f02e85a-6dca-467d-b2bf-ab2f9fa9ef3bAvailable 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
0143-1500-01Phenobarbital100 in 1 BOTTLETABLET10029
0143-1500-05Phenobarbital500 in 1 BOTTLETABLET50029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-1500-01EA - Each0143-1500578bd6cd-bc6e-4594-9e10-72e1be14830a12020-04-20
0143-1500-05EA - Each0143-1500223c8db2-b89a-44dc-8515-51d61fe4347712020-04-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENOBARBITALACTIVE INGREDIENTYQE403BP4DPHENOBARBITAL TABLET [WEST-WARD PHARMACEUTICAL CORP]11
PHENOBARBITALACTIVE MOIETYYQE403BP4DPHENOBARBITAL TABLET [WEST-WARD PHARMACEUTICAL CORP]11
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPHENOBARBITAL TABLET [WEST-WARD PHARMACEUTICAL CORP]11
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPHENOBARBITAL TABLET [WEST-WARD PHARMACEUTICAL CORP]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENOBARBITAL TABLET [WEST-WARD PHARMACEUTICAL CORP]11
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0PHENOBARBITAL TABLET [WEST-WARD PHARMACEUTICAL CORP]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENOBARBITAL TABLET [WEST-WARD PHARMACEUTICAL CORP]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENOBARBITAL TABLET [WEST-WARD PHARMACEUTICAL CORP]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENOBARBITAL TABLET [WEST-WARD PHARMACEUTICAL CORP]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PHENOBARBITAL TABLET [WEST-WARD PHARMACEUTICAL CORP]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENOBARBITAL TABLET [WEST-WARD PHARMACEUTICAL CORP]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-1500PHENOBARBITAL TABLET [HIKMA PHARMACEUTICALS USA INC.]29Current NDC, Legacy NDC, 2 package rows20240731_8f02e85a-6dca-467d-b2bf-ab2f9fa9ef3b.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
PhenobarbitalPHENOBARBITALHikma Pharmaceuticals USA Inc.8f02e85a-6dca-467d-b2bf-ab2f9fa9ef3b2024-07-30Warnings, Adverse reactionsExact identifier
ndc (product): 0143-1500

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198083PHENobarbital 100 MG Oral TabletPSN8f02e85a-6dca-467d-b2bf-ab2f9fa9ef3b29
312357PHENobarbital 15 MG Oral TabletPSN8f02e85a-6dca-467d-b2bf-ab2f9fa9ef3b29
312362PHENobarbital 30 MG Oral TabletPSN8f02e85a-6dca-467d-b2bf-ab2f9fa9ef3b29
198089PHENobarbital 60 MG Oral TabletPSN8f02e85a-6dca-467d-b2bf-ab2f9fa9ef3b29
198083phenobarbital 100 MG Oral TabletSCD8f02e85a-6dca-467d-b2bf-ab2f9fa9ef3b29
312357phenobarbital 15 MG Oral TabletSCD8f02e85a-6dca-467d-b2bf-ab2f9fa9ef3b29
312362phenobarbital 30 MG Oral TabletSCD8f02e85a-6dca-467d-b2bf-ab2f9fa9ef3b29
198089phenobarbital 60 MG Oral TabletSCD8f02e85a-6dca-467d-b2bf-ab2f9fa9ef3b29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-1500-0100143150001100 TABLET in 1 BOTTLE (0143-1500-01) 100 tablet2020-03-050000-00-00NoNoCurrent
0143-1500-0500143150005500 TABLET in 1 BOTTLE (0143-1500-05) 500 tablet2020-03-050000-00-00NoNoCurrent