FDA.reportPublic FDA data

Phenobarbital

Product NDC
0904-6575
11-digit product format
009046575
Labeler code
0904
Product ID
0904-6575_36cbae84-9974-4169-b168-f71f2dfba1e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2003-02-01
Marketing end
2027-02-28
Substance
PHENOBARBITAL
Active strength
32.4 mg/1
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0904-65750904-6575-80DDiscontinued by firm2026-08-17

Additional Listing Data#

Finished product
Yes
Brand name base
Phenobarbital

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOBARBITAL32.4 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199167Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e024b80b-c22f-44bc-b273-f9398f840ed0Available 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
0904-6575-61Phenobarbital100 in 1 CARTONTABLET10012
0904-6575-61Phenobarbital1 in 1 BLISTER PACKTABLET112
0904-6575-80Phenobarbital1000 in 1 BOTTLE, PLASTICTABLET100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6575-61EA - Each0904-65755f909a40-45b4-4053-bfde-17c708ebcf1412017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6575PHENOBARBITAL TABLET [MAJOR PHARMACEUTICALS]9Current NDC, Legacy NDC, 3 package rows20250406_e024b80b-c22f-44bc-b273-f9398f840ed0.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
PhenobarbitalPHENOBARBITALMajor Pharmaceuticalse024b80b-c22f-44bc-b273-f9398f840ed02026-04-30Warnings, Adverse reactionsExact identifier
ndc (product): 0904-6575

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199167PHENobarbital 32.4 MG Oral TabletPSNe024b80b-c22f-44bc-b273-f9398f840ed012
199167phenobarbital 32.4 MG Oral TabletSCDe024b80b-c22f-44bc-b273-f9398f840ed012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6575-6100904657561100 BLISTER PACK in 1 CARTON (0904-6575-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2003-02-012027-02-28NoNoCurrent
0904-6575-80009046575801000 TABLET in 1 BOTTLE, PLASTIC (0904-6575-80) 1000 tablet2003-02-012026-05-31NoNoCurrent