FDA.reportPublic FDA data

Phenobarbital

Product NDC
69367-212
11-digit product format
693670212
Labeler code
69367
Product ID
69367-212_aa193c29-8394-4345-b3a6-cb6dba0e990e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2019-05-21
Marketing end
0000-00-00
Substance
PHENOBARBITAL
Active strength
32 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69367-212DDiscontinued by firm2026-10-05
excluded packagepackage69367-21269367-212-01DDiscontinued by firm2026-10-05
excluded packagepackage69367-21269367-212-10DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
69367-212-01Phenobarbital100 in 1 BOTTLE, PLASTICTABLET1007
69367-212-10Phenobarbital1000 in 1 BOTTLE, PLASTICTABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-212-01EA - Each69367-21271d91116-298c-4eb6-b898-0ab48ba706cb12019-07-02
69367-212-10EA - Each69367-212a088e20d-ff21-4ba2-a80f-c532fe9b776312019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-212PHENOBARBITAL TABLET [WESTMINSTER PHARMACEUTICALS, LLC]6Legacy NDC, 2 package rows20230726_d8a5874a-5ea7-456c-87d4-95b3188abc9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198086PHENobarbital 16.2 MG Oral TabletPSNd8a5874a-5ea7-456c-87d4-95b3188abc9b7
199167PHENobarbital 32.4 MG Oral TabletPSNd8a5874a-5ea7-456c-87d4-95b3188abc9b7
199168PHENobarbital 64.8 MG Oral TabletPSNd8a5874a-5ea7-456c-87d4-95b3188abc9b7
199164PHENobarbital 97.2 MG Oral TabletPSNd8a5874a-5ea7-456c-87d4-95b3188abc9b7
198086phenobarbital 16.2 MG Oral TabletSCDd8a5874a-5ea7-456c-87d4-95b3188abc9b7
199167phenobarbital 32.4 MG Oral TabletSCDd8a5874a-5ea7-456c-87d4-95b3188abc9b7
199168phenobarbital 64.8 MG Oral TabletSCDd8a5874a-5ea7-456c-87d4-95b3188abc9b7
199164phenobarbital 97.2 MG Oral TabletSCDd8a5874a-5ea7-456c-87d4-95b3188abc9b7
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
199167PHENobarbital 32.4 MG Oral TabletPSNbd5c8684-8095-de7e-e053-2a95a90a652d2
199167phenobarbital 32.4 MG Oral TabletSCDbd5c8684-8095-de7e-e053-2a95a90a652d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69367-212-0169367021201100 TABLET in 1 BOTTLE, PLASTIC (69367-212-01) 100 tablet2019-05-210000-00-00NoNoCurrent
69367-212-10693670212101000 TABLET in 1 BOTTLE, PLASTIC (69367-212-10) 1000 tablet2019-05-210000-00-00NoNoCurrent