FDA.reportPublic FDA data

Phenobarbital

Product NDC
71205-892
Requested package NDC
71205-892-60
11-digit product format
712050892
Labeler code
71205
Product ID
71205-892_e8057c39-a5b1-491e-8dc5-2e697b17af38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2019-05-21
Substance
PHENOBARBITAL
Active strength
64.8 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
PHENOBARBITAL64.8 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
71368966-b2d6-44cb-9418-050fe943af73Available 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
71205-892-00Phenobarbital100 in 1 BOTTLE, PLASTICTABLET1003
71205-892-11Phenobarbital1000 in 1 BOTTLE, PLASTICTABLET10003
71205-892-30Phenobarbital30 in 1 BOTTLE, PLASTICTABLET303
71205-892-55Phenobarbital500 in 1 BOTTLE, PLASTICTABLET5003
71205-892-60Phenobarbital60 in 1 BOTTLE, PLASTICTABLET603
71205-892-90Phenobarbital90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-892-00EA - Each71205-89206ca9fb3-6a27-4bcd-aaa5-1ec661923ae512021-09-07
71205-892-11EA - Each71205-892f583541a-4256-443a-83ed-2f7915997bd612021-09-07
71205-892-30EA - Each71205-8925d2c600b-4ab3-4e5d-bae6-9100c6bdf13612021-09-07
71205-892-55EA - Each71205-892c36d8312-eac3-4232-a46e-fac71e4636c012021-09-07
71205-892-60EA - Each71205-8924130cfa9-74b2-4d9f-aa61-fcf34a2cf36e12021-09-07
71205-892-90EA - Each71205-8929e47c87f-1f90-46b6-89c1-8ae09a4b460112021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-892PHENOBARBITAL TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 6 package rows20250321_71368966-b2d6-44cb-9418-050fe943af73.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 LP71368966-b2d6-44cb-9418-050fe943af732025-03-01Warnings, Adverse reactionsExact identifier
ndc (package): 71205-892-60
ndc (product): 71205-892
ndc11 (package): 71205089260

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198086PHENobarbital 16.2 MG Oral TabletPSN71368966-b2d6-44cb-9418-050fe943af733
199167PHENobarbital 32.4 MG Oral TabletPSN71368966-b2d6-44cb-9418-050fe943af733
199168PHENobarbital 64.8 MG Oral TabletPSN71368966-b2d6-44cb-9418-050fe943af733
199164PHENobarbital 97.2 MG Oral TabletPSN71368966-b2d6-44cb-9418-050fe943af733
198086phenobarbital 16.2 MG Oral TabletSCD71368966-b2d6-44cb-9418-050fe943af733
199167phenobarbital 32.4 MG Oral TabletSCD71368966-b2d6-44cb-9418-050fe943af733
199168phenobarbital 64.8 MG Oral TabletSCD71368966-b2d6-44cb-9418-050fe943af733
199164phenobarbital 97.2 MG Oral TabletSCD71368966-b2d6-44cb-9418-050fe943af733

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-892-607120508926060 TABLET in 1 BOTTLE, PLASTIC (71205-892-60) 60 tablet2021-08-030000-00-00NoNoCurrent