FDA.reportPublic FDA data

Phenobarbital

Product NDC
82804-983
11-digit product format
828040983
Labeler code
82804
Product ID
82804-983_6b5ca781-50a9-4e89-8184-831c7c2936b2
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
32.4 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
PHENOBARBITAL32.4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYQE403BP4D
Rxcui198086, 199164, 199167, 199168

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
82804-983-00Phenobarbital100 in 1 BOTTLETABLET1001
82804-983-11Phenobarbital1000 in 1 BOTTLETABLET10001
82804-983-30Phenobarbital30 in 1 BOTTLETABLET301
82804-983-55Phenobarbital500 in 1 BOTTLETABLET5001
82804-983-60Phenobarbital60 in 1 BOTTLETABLET601
82804-983-90Phenobarbital90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-983-00EA - Each82804-983a2914584-76a9-4897-9c76-606738d16fe012024-12-10
82804-983-11EA - Each82804-983d0ad510f-98f5-4436-a629-96763794902812024-12-10
82804-983-30EA - Each82804-98392d84e91-6aa0-4031-a829-42f6c77fd10612024-12-10
82804-983-55EA - Each82804-9830980136a-afa4-41e3-864e-58623b29e8d912024-12-10
82804-983-60EA - Each82804-98393d78960-62b1-4497-9b32-9a1722d682a912024-12-10
82804-983-90EA - Each82804-9834e90cdf8-dffb-45d8-9b84-fdb03180b19e12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-983PHENOBARBITAL TABLET [PROFICIENT RX LP]1Current NDC, 6 package rows20241030_6b5ca781-50a9-4e89-8184-831c7c2936b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198086PHENobarbital 16.2 MG Oral TabletPSN6b5ca781-50a9-4e89-8184-831c7c2936b21
199167PHENobarbital 32.4 MG Oral TabletPSN6b5ca781-50a9-4e89-8184-831c7c2936b21
199168PHENobarbital 64.8 MG Oral TabletPSN6b5ca781-50a9-4e89-8184-831c7c2936b21
199164PHENobarbital 97.2 MG Oral TabletPSN6b5ca781-50a9-4e89-8184-831c7c2936b21
198086phenobarbital 16.2 MG Oral TabletSCD6b5ca781-50a9-4e89-8184-831c7c2936b21
199167phenobarbital 32.4 MG Oral TabletSCD6b5ca781-50a9-4e89-8184-831c7c2936b21
199168phenobarbital 64.8 MG Oral TabletSCD6b5ca781-50a9-4e89-8184-831c7c2936b21
199164phenobarbital 97.2 MG Oral TabletSCD6b5ca781-50a9-4e89-8184-831c7c2936b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-983-0082804098300100 TABLET in 1 BOTTLE (82804-983-00) 100 tablet2024-10-28NoNoHistorical
82804-983-11828040983111000 TABLET in 1 BOTTLE (82804-983-11) 1000 tablet2024-10-28NoNoHistorical
82804-983-308280409833030 TABLET in 1 BOTTLE (82804-983-30) 30 tablet2024-10-28NoNoHistorical
82804-983-5582804098355500 TABLET in 1 BOTTLE (82804-983-55) 500 tablet2024-10-28NoNoHistorical
82804-983-608280409836060 TABLET in 1 BOTTLE (82804-983-60) 60 tablet2024-10-28NoNoHistorical
82804-983-908280409839090 TABLET in 1 BOTTLE (82804-983-90) 90 tablet2024-10-28NoNoHistorical