FDA.reportPublic FDA data

Phenobarbital

Product NDC
82804-985
11-digit product format
828040985
Labeler code
82804
Product ID
82804-985_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
97.2 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
PHENOBARBITAL97.2 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
82804-985-00Phenobarbital100 in 1 BOTTLETABLET1001
82804-985-11Phenobarbital1000 in 1 BOTTLETABLET10001
82804-985-30Phenobarbital30 in 1 BOTTLETABLET301
82804-985-55Phenobarbital500 in 1 BOTTLETABLET5001
82804-985-60Phenobarbital60 in 1 BOTTLETABLET601
82804-985-90Phenobarbital90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-985-00EA - Each82804-9852f5b55ea-d449-40bb-8567-1fe989c68b9d12024-12-10
82804-985-11EA - Each82804-9859cead506-a981-4d40-b780-02d53d0b0e0312024-12-10
82804-985-30EA - Each82804-98559431ed2-7443-48de-a00f-25715cb8d07312024-12-10
82804-985-55EA - Each82804-9852e8644d9-3b5e-4adb-bc42-244f54fc80fb12024-12-10
82804-985-60EA - Each82804-985ae4437dd-981d-4dc9-bf5b-f78f9c36910a12024-12-10
82804-985-90EA - Each82804-985aa0a35f8-45f6-4653-aba0-ba6b155e001512024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-985PHENOBARBITAL 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
82804-985-0082804098500100 TABLET in 1 BOTTLE (82804-985-00) 100 tablet2024-10-28NoNoCurrent
82804-985-11828040985111000 TABLET in 1 BOTTLE (82804-985-11) 1000 tablet2024-10-28NoNoCurrent
82804-985-308280409853030 TABLET in 1 BOTTLE (82804-985-30) 30 tablet2024-10-28NoNoCurrent
82804-985-5582804098555500 TABLET in 1 BOTTLE (82804-985-55) 500 tablet2024-10-28NoNoCurrent
82804-985-608280409856060 TABLET in 1 BOTTLE (82804-985-60) 60 tablet2024-10-28NoNoCurrent
82804-985-908280409859090 TABLET in 1 BOTTLE (82804-985-90) 90 tablet2024-10-28NoNoCurrent