FDA.reportPublic FDA data

Phenobarbital

Product NDC
82804-999
11-digit product format
828040999
Labeler code
82804
Product ID
82804-999_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
100 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
PHENOBARBITAL100 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
82804-999-00Phenobarbital100 in 1 BOTTLETABLET1001
82804-999-11Phenobarbital1000 in 1 BOTTLETABLET10001
82804-999-30Phenobarbital30 in 1 BOTTLETABLET301
82804-999-55Phenobarbital500 in 1 BOTTLETABLET5001
82804-999-60Phenobarbital60 in 1 BOTTLETABLET601
82804-999-64Phenobarbital240 in 1 BOTTLETABLET2401
82804-999-72Phenobarbital120 in 1 BOTTLETABLET1201
82804-999-78Phenobarbital180 in 1 BOTTLETABLET1801
82804-999-90Phenobarbital90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-999-00EA - Each82804-99986c44c54-497a-4e30-a3ff-e30c0a63437212024-05-16
82804-999-11EA - Each82804-99946b0ddd0-bf01-4d8f-b889-1b68abd1c40312024-05-16
82804-999-30EA - Each82804-999920040c4-f6db-4a89-a4b9-3d94d939b39312024-05-16
82804-999-55EA - Each82804-99925fb6469-1bfc-4f8b-9d4d-72cca60141b112024-05-16
82804-999-60EA - Each82804-999efcca95c-b126-4299-8258-d6a08a96b6db12024-05-16
82804-999-64EA - Each82804-999871ffb48-1bf1-4b33-b840-66114b1b6dc812024-05-16
82804-999-72EA - Each82804-99989a53a83-fba6-485a-867a-d0ecde5ddc1f12024-05-16
82804-999-78EA - Each82804-999013a2e07-15c8-4650-a3c5-2c2b29adcac412024-05-16
82804-999-90EA - Each82804-999afa55a5f-caf6-4ba3-a8b7-10fa73a7fcd112024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-999PHENOBARBITAL 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
82804-999-0082804099900100 TABLET in 1 BOTTLE (82804-999-00) 100 tablet2024-03-25NoNoHistorical
82804-999-11828040999111000 TABLET in 1 BOTTLE (82804-999-11) 1000 tablet2024-03-25NoNoHistorical
82804-999-308280409993030 TABLET in 1 BOTTLE (82804-999-30) 30 tablet2024-03-25NoNoHistorical
82804-999-5582804099955500 TABLET in 1 BOTTLE (82804-999-55) 500 tablet2024-03-25NoNoHistorical
82804-999-608280409996060 TABLET in 1 BOTTLE (82804-999-60) 60 tablet2024-03-25NoNoHistorical
82804-999-6482804099964240 TABLET in 1 BOTTLE (82804-999-64) 240 tablet2024-03-25NoNoHistorical
82804-999-7282804099972120 TABLET in 1 BOTTLE (82804-999-72) 120 tablet2024-03-25NoNoHistorical
82804-999-7882804099978180 TABLET in 1 BOTTLE (82804-999-78) 180 tablet2024-03-25NoNoHistorical
82804-999-908280409999090 TABLET in 1 BOTTLE (82804-999-90) 90 tablet2024-03-25NoNoHistorical