FDA.reportPublic FDA data

Phenobarbital

Product NDC
71205-890
11-digit product format
712050890
Labeler code
71205
Product ID
71205-890_886f2c7d-6a6e-4d73-bbbd-61cff9514a87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-11-01
Substance
PHENOBARBITAL
Active strength
30 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
PHENOBARBITAL30 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
312362Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8fd2647b-6c3a-4b4c-a93b-304be364baf3Available 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
71205-890-00Phenobarbital100 in 1 BOTTLETABLET1002
71205-890-11Phenobarbital1000 in 1 BOTTLETABLET10002
71205-890-30Phenobarbital30 in 1 BOTTLETABLET302
71205-890-55Phenobarbital500 in 1 BOTTLETABLET5002
71205-890-60Phenobarbital60 in 1 BOTTLETABLET602
71205-890-90Phenobarbital90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-890-00EA - Each71205-890bf737b6b-6e4d-460c-a12d-d8222586140412021-09-07
71205-890-11EA - Each71205-890bf91b9ed-f171-4642-a9c4-de497b0b6c4f12021-09-07
71205-890-30EA - Each71205-89062f1fa36-bcd8-4b15-a397-565ab0b42e9d12021-09-07
71205-890-55EA - Each71205-89002c60f46-c027-40b8-be2c-d6b2bdd0d7b812021-09-07
71205-890-60EA - Each71205-8903d72b859-5f3c-4055-b45f-68e55c9b6aa912021-09-07
71205-890-90EA - Each71205-8906bc9c5b0-6c59-4fc4-92fc-c259694761d612021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-890PHENOBARBITAL TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 6 package rows20220820_8fd2647b-6c3a-4b4c-a93b-304be364baf3.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 LP8fd2647b-6c3a-4b4c-a93b-304be364baf32022-08-01Warnings, Adverse reactionsExact identifier
ndc (product): 71205-890

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312362PHENobarbital 30 MG Oral TabletPSN8fd2647b-6c3a-4b4c-a93b-304be364baf32
312362phenobarbital 30 MG Oral TabletSCD8fd2647b-6c3a-4b4c-a93b-304be364baf32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-890-0071205089000100 TABLET in 1 BOTTLE (71205-890-00) 100 tablet2021-08-030000-00-00NoNoCurrent
71205-890-11712050890111000 TABLET in 1 BOTTLE (71205-890-11) 1000 tablet2021-08-030000-00-00NoNoCurrent
71205-890-307120508903030 TABLET in 1 BOTTLE (71205-890-30) 30 tablet2021-08-030000-00-00NoNoCurrent
71205-890-5571205089055500 TABLET in 1 BOTTLE (71205-890-55) 500 tablet2021-08-030000-00-00NoNoCurrent
71205-890-607120508906060 TABLET in 1 BOTTLE (71205-890-60) 60 tablet2021-08-030000-00-00NoNoCurrent
71205-890-907120508909090 TABLET in 1 BOTTLE (71205-890-90) 90 tablet2021-08-030000-00-00NoNoCurrent