FDA.reportPublic FDA data

Phenobarbital

Product NDC
82804-985
Requested package NDC
82804-985-11
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
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
PHENOBARBITAL97.2 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
198086Internal RxNorm lookup
199164Internal RxNorm lookup
199167Internal RxNorm lookup
199168Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6b5ca781-50a9-4e89-8184-831c7c2936b2Available 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
82804-985-00Phenobarbital100 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

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 LP6b5ca781-50a9-4e89-8184-831c7c2936b22024-10-01Warnings, Adverse reactionsExact identifier
ndc (package): 82804-985-11
ndc (product): 82804-985
ndc11 (package): 82804098511

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
82804-985-11828040985111000 TABLET in 1 BOTTLE (82804-985-11) 1000 tablet2024-10-28NoNoCurrent