FDA.reportPublic FDA data

Phenobarbital

Product NDC
67296-1427
Requested package NDC
67296-1427-2
11-digit product format
672961427
Labeler code
67296
Product ID
67296-1427_bd5c8684-8096-de7e-e053-2a95a90a652d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
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
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67296-142767296-1427-2IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1427-22024-08-07C16284748780-1f386c649-f24c-0266-e053-dadaa90a7c1aPHENOBARBITAL 32.4mg TABLETS
67296-1427-22023-01-30C16284748780-1f386c649-f24c-0266-e053-dadaa90a7c1aPHENOBARBITAL 32.4mg TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1427-2Phenobarbital20 in 1 BOTTLETABLET202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1427PHENOBARBITAL TABLET [REDPHARM DRUG, INC.]2Legacy NDC, 1 package rows20240808_bd5c8684-8095-de7e-e053-2a95a90a652d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
67296-1427-26729614270220 TABLET in 1 BOTTLE (67296-1427-2) 20 tablet2021-03-010000-00-00NoNoCurrent