FDA.reportPublic FDA data

Phenobarbital

Product NDC
51672-5332
11-digit product format
516725332
Labeler code
51672
Product ID
51672-5332_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
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
2027-12-31

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 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198083Internal RxNorm lookup
198086Internal RxNorm lookup
198089Internal RxNorm lookup
199164Internal RxNorm lookup
199167Internal RxNorm lookup
199168Internal 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
fa09b4f2-edb0-4594-a2d2-b16f7b9686b4Available 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
51672-5332-1Phenobarbital100 in 1 BOTTLE, PLASTICTABLET1001
51672-5332-3Phenobarbital1000 in 1 BOTTLE, PLASTICTABLET10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-5332PHENOBARBITAL TABLET [TARO PHARMACEUTICALS U.S.A. INC.]1Current NDC, 2 package rows20240802_fa09b4f2-edb0-4594-a2d2-b16f7b9686b4.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
PhenobarbitalPHENOBARBITALSun Pharmaceutical Industries, Inc.fa09b4f2-edb0-4594-a2d2-b16f7b9686b42026-07-14Warnings, Adverse reactionsExact identifier
ndc (product): 51672-5332

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
51672-5332-151672533201100 TABLET in 1 BOTTLE, PLASTIC (51672-5332-1) 100 tablet2024-08-01NoNoCurrent
51672-5332-3516725332031000 TABLET in 1 BOTTLE, PLASTIC (51672-5332-3) 1000 tablet2024-08-01NoNoCurrent