FDA.reportPublic FDA data

Phenobarbital

Product NDC
71205-891
11-digit product format
712050891
Labeler code
71205
Product ID
71205-891_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
32.4 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phenobarbital
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOBARBITAL32.4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYQE403BP4D
Rxcui198086, 199164, 199167, 199168

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
71205-891-00Phenobarbital100 in 1 BOTTLE, PLASTICTABLET1003
71205-891-11Phenobarbital1000 in 1 BOTTLE, PLASTICTABLET10003
71205-891-30Phenobarbital30 in 1 BOTTLE, PLASTICTABLET303
71205-891-55Phenobarbital500 in 1 BOTTLE, PLASTICTABLET5003
71205-891-60Phenobarbital60 in 1 BOTTLE, PLASTICTABLET603
71205-891-90Phenobarbital90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-891-00EA - Each71205-891398c0235-4297-4e8b-a74a-ac57e37421d112021-09-07
71205-891-11EA - Each71205-8917083f0af-98f0-4cfc-8a26-00c27e5a699612021-09-07
71205-891-30EA - Each71205-891af38bc43-79b8-48d5-bf69-f150c6f7886d12021-09-07
71205-891-55EA - Each71205-891eaf742e4-49cb-4e2e-991d-7ab06a6eb2f212021-09-07
71205-891-60EA - Each71205-89173421da0-c210-471f-97a9-6550e43ba3cd12021-09-07
71205-891-90EA - Each71205-891f3d8dc1d-b209-4607-9729-da0ae3dc3b4f12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-891PHENOBARBITAL TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 6 package rows20250321_71368966-b2d6-44cb-9418-050fe943af73.zip

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
71205-891-0071205089100100 TABLET in 1 BOTTLE, PLASTIC (71205-891-00) 100 tablet2021-08-030000-00-00NoNoCurrent
71205-891-11712050891111000 TABLET in 1 BOTTLE, PLASTIC (71205-891-11) 1000 tablet2021-08-030000-00-00NoNoCurrent
71205-891-307120508913030 TABLET in 1 BOTTLE, PLASTIC (71205-891-30) 30 tablet2021-08-030000-00-00NoNoCurrent
71205-891-5571205089155500 TABLET in 1 BOTTLE, PLASTIC (71205-891-55) 500 tablet2021-08-030000-00-00NoNoCurrent
71205-891-607120508916060 TABLET in 1 BOTTLE, PLASTIC (71205-891-60) 60 tablet2021-08-030000-00-00NoNoCurrent
71205-891-907120508919090 TABLET in 1 BOTTLE, PLASTIC (71205-891-90) 90 tablet2021-08-030000-00-00NoNoCurrent