FDA.reportPublic FDA data

Phenobarbital

Product NDC
0143-1455
11-digit product format
001431455
Labeler code
0143
Product ID
0143-1455_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
1999-01-11
Substance
PHENOBARBITAL
Active strength
60 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
PHENOBARBITAL60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYQE403BP4D
Rxcui198083, 198089, 312357, 312362

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
0143-1455-01Phenobarbital100 in 1 BOTTLETABLET10029
0143-1455-05Phenobarbital500 in 1 BOTTLETABLET50029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-1455-01EA - Each0143-1455abc5d52f-57cb-4a28-a6e1-c06b07ec0dd212016-04-04
0143-1455-05EA - Each0143-1455aef2655a-29b0-4a36-b6af-680b18f7f69a12012-07-24

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
0143-1455PHENOBARBITAL TABLET [HIKMA PHARMACEUTICALS USA INC.]29Current NDC, Legacy NDC, 2 package rows20240731_8f02e85a-6dca-467d-b2bf-ab2f9fa9ef3b.zip

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
0143-1455-0100143145501100 TABLET in 1 BOTTLE (0143-1455-01) 100 tablet1999-01-110000-00-00NoNoCurrent
0143-1455-0500143145505500 TABLET in 1 BOTTLE (0143-1455-05) 500 tablet1999-01-110000-00-00NoNoCurrent