FDA.reportPublic FDA data

Phenobarbital

Product NDC
51672-5331
11-digit product format
516725331
Labeler code
51672
Product ID
51672-5331_bc2d569d-e2c5-4a94-b259-cac1fcc6cdf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
Taro Pharmaceuticals U.S.A. Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-08-01
Substance
PHENOBARBITAL
Active strength
15 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
PHENOBARBITAL15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYQE403BP4D
Rxcui198083, 198086, 198089, 199164, 199167, 199168, 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
51672-5331-1Phenobarbital100 in 1 BOTTLE, PLASTICTABLET1001
51672-5331-3Phenobarbital1000 in 1 BOTTLE, PLASTICTABLET10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-5331PHENOBARBITAL TABLET [TARO PHARMACEUTICALS U.S.A. INC.]1Current NDC, 2 package rows20240802_fa09b4f2-edb0-4594-a2d2-b16f7b9686b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198083PHENobarbital 100 MG Oral TabletPSNfa09b4f2-edb0-4594-a2d2-b16f7b9686b41
312357PHENobarbital 15 MG Oral TabletPSNfa09b4f2-edb0-4594-a2d2-b16f7b9686b41
198086PHENobarbital 16.2 MG Oral TabletPSNfa09b4f2-edb0-4594-a2d2-b16f7b9686b41
312362PHENobarbital 30 MG Oral TabletPSNfa09b4f2-edb0-4594-a2d2-b16f7b9686b41
199167PHENobarbital 32.4 MG Oral TabletPSNfa09b4f2-edb0-4594-a2d2-b16f7b9686b41
198089PHENobarbital 60 MG Oral TabletPSNfa09b4f2-edb0-4594-a2d2-b16f7b9686b41
199168PHENobarbital 64.8 MG Oral TabletPSNfa09b4f2-edb0-4594-a2d2-b16f7b9686b41
199164PHENobarbital 97.2 MG Oral TabletPSNfa09b4f2-edb0-4594-a2d2-b16f7b9686b41
198083phenobarbital 100 MG Oral TabletSCDfa09b4f2-edb0-4594-a2d2-b16f7b9686b41
312357phenobarbital 15 MG Oral TabletSCDfa09b4f2-edb0-4594-a2d2-b16f7b9686b41
198086phenobarbital 16.2 MG Oral TabletSCDfa09b4f2-edb0-4594-a2d2-b16f7b9686b41
312362phenobarbital 30 MG Oral TabletSCDfa09b4f2-edb0-4594-a2d2-b16f7b9686b41
199167phenobarbital 32.4 MG Oral TabletSCDfa09b4f2-edb0-4594-a2d2-b16f7b9686b41
198089phenobarbital 60 MG Oral TabletSCDfa09b4f2-edb0-4594-a2d2-b16f7b9686b41
199168phenobarbital 64.8 MG Oral TabletSCDfa09b4f2-edb0-4594-a2d2-b16f7b9686b41
199164phenobarbital 97.2 MG Oral TabletSCDfa09b4f2-edb0-4594-a2d2-b16f7b9686b41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51672-5331-151672533101100 TABLET in 1 BOTTLE, PLASTIC (51672-5331-1) 100 tablet2024-08-01NoNoHistorical
51672-5331-3516725331031000 TABLET in 1 BOTTLE, PLASTIC (51672-5331-3) 1000 tablet2024-08-01NoNoHistorical