FDA.reportPublic FDA data

Phenobarbital

Product NDC
82804-998
11-digit product format
828040998
Labeler code
82804
Product ID
82804-998_7d6516be-285b-41be-a1f3-8c9ad8857316
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-09-08
Substance
PHENOBARBITAL
Active strength
60 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Phenobarbital
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOBARBITAL60 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
7d6516be-285b-41be-a1f3-8c9ad8857316Available 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
82804-998-00Phenobarbital100 in 1 BOTTLETABLET1001
82804-998-11Phenobarbital1000 in 1 BOTTLETABLET10001
82804-998-30Phenobarbital30 in 1 BOTTLETABLET301
82804-998-55Phenobarbital500 in 1 BOTTLETABLET5001
82804-998-60Phenobarbital60 in 1 BOTTLETABLET601
82804-998-64Phenobarbital240 in 1 BOTTLETABLET2401
82804-998-72Phenobarbital120 in 1 BOTTLETABLET1201
82804-998-78Phenobarbital180 in 1 BOTTLETABLET1801
82804-998-90Phenobarbital90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-998-00EA - Each82804-998d825cdea-0360-479a-88a6-9b7aa33f9d4a12024-05-16
82804-998-11EA - Each82804-9983e020f06-a5f1-4682-8a93-2801bd325b6d12024-05-16
82804-998-30EA - Each82804-99801c01847-2639-41be-8a2e-aef14f0e07fc12024-05-16
82804-998-55EA - Each82804-998065d91cf-5524-4d8d-ad32-27d1332e74b812024-05-16
82804-998-60EA - Each82804-998fd4cd67d-154c-4993-aad5-117265c7362312024-05-16
82804-998-64EA - Each82804-99828d8be50-eb49-4dc7-931e-f829626e131d12024-05-16
82804-998-72EA - Each82804-9980b1f3f9a-f378-4ff6-883e-ab41cbf35e0e12024-05-16
82804-998-78EA - Each82804-9988d68e486-94fd-4650-8b73-e7c1d4fd6c1012024-05-16
82804-998-90EA - Each82804-998ea7a12df-736a-422c-b4ed-6651988b8dbe12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-998PHENOBARBITAL TABLET [PROFICIENT RX LP]1Current NDC, 9 package rows20240327_7d6516be-285b-41be-a1f3-8c9ad8857316.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
PhenobarbitalPHENOBARBITALProficient Rx LP7d6516be-285b-41be-a1f3-8c9ad88573162024-03-01Warnings, Adverse reactionsExact identifier
ndc (product): 82804-998

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198083PHENobarbital 100 MG Oral TabletPSN7d6516be-285b-41be-a1f3-8c9ad88573161
312357PHENobarbital 15 MG Oral TabletPSN7d6516be-285b-41be-a1f3-8c9ad88573161
312362PHENobarbital 30 MG Oral TabletPSN7d6516be-285b-41be-a1f3-8c9ad88573161
198089PHENobarbital 60 MG Oral TabletPSN7d6516be-285b-41be-a1f3-8c9ad88573161
198083phenobarbital 100 MG Oral TabletSCD7d6516be-285b-41be-a1f3-8c9ad88573161
312357phenobarbital 15 MG Oral TabletSCD7d6516be-285b-41be-a1f3-8c9ad88573161
312362phenobarbital 30 MG Oral TabletSCD7d6516be-285b-41be-a1f3-8c9ad88573161
198089phenobarbital 60 MG Oral TabletSCD7d6516be-285b-41be-a1f3-8c9ad88573161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-998-0082804099800100 TABLET in 1 BOTTLE (82804-998-00) 100 tablet2024-03-25NoNoCurrent
82804-998-11828040998111000 TABLET in 1 BOTTLE (82804-998-11) 1000 tablet2024-03-25NoNoCurrent
82804-998-308280409983030 TABLET in 1 BOTTLE (82804-998-30) 30 tablet2024-03-25NoNoCurrent
82804-998-5582804099855500 TABLET in 1 BOTTLE (82804-998-55) 500 tablet2024-03-25NoNoCurrent
82804-998-608280409986060 TABLET in 1 BOTTLE (82804-998-60) 60 tablet2024-03-25NoNoCurrent
82804-998-6482804099864240 TABLET in 1 BOTTLE (82804-998-64) 240 tablet2024-03-25NoNoCurrent
82804-998-7282804099872120 TABLET in 1 BOTTLE (82804-998-72) 120 tablet2024-03-25NoNoCurrent
82804-998-7882804099878180 TABLET in 1 BOTTLE (82804-998-78) 180 tablet2024-03-25NoNoCurrent
82804-998-908280409989090 TABLET in 1 BOTTLE (82804-998-90) 90 tablet2024-03-25NoNoCurrent