FDA.reportPublic FDA data

Phenobarbital

Product NDC
71205-845
Requested package NDC
71205-845-78
11-digit product format
712050845
Labeler code
71205
Product ID
71205-845_6cf88fef-0c82-4d5d-85e8-5896ac013165
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
15 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
PHENOBARBITAL15 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198083Internal RxNorm lookup
198089Internal RxNorm lookup
312357Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6cf88fef-0c82-4d5d-85e8-5896ac013165Available 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
71205-845-00Phenobarbital100 in 1 BOTTLETABLET1001
71205-845-11Phenobarbital1000 in 1 BOTTLETABLET10001
71205-845-30Phenobarbital30 in 1 BOTTLETABLET301
71205-845-55Phenobarbital500 in 1 BOTTLETABLET5001
71205-845-60Phenobarbital60 in 1 BOTTLETABLET601
71205-845-64Phenobarbital240 in 1 BOTTLETABLET2401
71205-845-72Phenobarbital120 in 1 BOTTLETABLET1201
71205-845-78Phenobarbital180 in 1 BOTTLETABLET1801
71205-845-90Phenobarbital90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-845-00EA - Each71205-84527db584d-7544-4252-a1f0-2882aeb8858912023-03-13
71205-845-11EA - Each71205-845f29a3e1e-cdda-4eff-977a-7cc53373b76612023-03-13
71205-845-30EA - Each71205-845e85460d5-a861-4029-a68c-1ea0943797f612023-03-13
71205-845-55EA - Each71205-84554880716-fddd-453b-a136-8d84140e5c5a12023-03-13
71205-845-60EA - Each71205-8450544a574-060a-474b-9c02-f16efeffcd9312023-03-13
71205-845-64EA - Each71205-845b9cd0004-5c70-4189-8374-32272118839212023-03-13
71205-845-72EA - Each71205-845df9abb1f-d01b-4693-b8bf-6c8450185f0312023-03-13
71205-845-78EA - Each71205-84519790bdb-bba1-4b7c-b511-4076ff52b07f12023-03-13
71205-845-90EA - Each71205-8459351be44-92f3-4ff5-a293-ce43c48c33f712023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-845PHENOBARBITAL TABLET [PROFICIENT RX LP]1Current NDC, 9 package rows20230214_6cf88fef-0c82-4d5d-85e8-5896ac013165.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 LP6cf88fef-0c82-4d5d-85e8-5896ac0131652023-02-01Warnings, Adverse reactionsExact identifier
ndc (package): 71205-845-78
ndc (product): 71205-845
ndc11 (package): 71205084578

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198083PHENobarbital 100 MG Oral TabletPSN6cf88fef-0c82-4d5d-85e8-5896ac0131651
312357PHENobarbital 15 MG Oral TabletPSN6cf88fef-0c82-4d5d-85e8-5896ac0131651
198089PHENobarbital 60 MG Oral TabletPSN6cf88fef-0c82-4d5d-85e8-5896ac0131651
198083phenobarbital 100 MG Oral TabletSCD6cf88fef-0c82-4d5d-85e8-5896ac0131651
312357phenobarbital 15 MG Oral TabletSCD6cf88fef-0c82-4d5d-85e8-5896ac0131651
198089phenobarbital 60 MG Oral TabletSCD6cf88fef-0c82-4d5d-85e8-5896ac0131651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-845-7871205084578180 TABLET in 1 BOTTLE (71205-845-78) 180 tablet2023-02-13NoNoCurrent