FDA.reportPublic FDA data

Phenobarbital

Product NDC
82804-997
11-digit product format
828040997
Labeler code
82804
Product ID
82804-997_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
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 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
82804-997-00Phenobarbital100 in 1 BOTTLETABLET1001
82804-997-11Phenobarbital1000 in 1 BOTTLETABLET10001
82804-997-30Phenobarbital30 in 1 BOTTLETABLET301
82804-997-55Phenobarbital500 in 1 BOTTLETABLET5001
82804-997-60Phenobarbital60 in 1 BOTTLETABLET601
82804-997-64Phenobarbital240 in 1 BOTTLETABLET2401
82804-997-72Phenobarbital120 in 1 BOTTLETABLET1201
82804-997-78Phenobarbital180 in 1 BOTTLETABLET1801
82804-997-90Phenobarbital90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-997PHENOBARBITAL TABLET [PROFICIENT RX LP]1Current NDC, 9 package rows20240327_7d6516be-285b-41be-a1f3-8c9ad8857316.zip

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
82804-997-0082804099700100 TABLET in 1 BOTTLE (82804-997-00) 100 tablet2024-03-25NoNoCurrent
82804-997-11828040997111000 TABLET in 1 BOTTLE (82804-997-11) 1000 tablet2024-03-25NoNoCurrent
82804-997-308280409973030 TABLET in 1 BOTTLE (82804-997-30) 30 tablet2024-03-25NoNoCurrent
82804-997-5582804099755500 TABLET in 1 BOTTLE (82804-997-55) 500 tablet2024-03-25NoNoCurrent
82804-997-608280409976060 TABLET in 1 BOTTLE (82804-997-60) 60 tablet2024-03-25NoNoCurrent
82804-997-6482804099764240 TABLET in 1 BOTTLE (82804-997-64) 240 tablet2024-03-25NoNoCurrent
82804-997-7282804099772120 TABLET in 1 BOTTLE (82804-997-72) 120 tablet2024-03-25NoNoCurrent
82804-997-7882804099778180 TABLET in 1 BOTTLE (82804-997-78) 180 tablet2024-03-25NoNoCurrent
82804-997-908280409979090 TABLET in 1 BOTTLE (82804-997-90) 90 tablet2024-03-25NoNoCurrent