FDA.reportPublic FDA data

Phenobarbital

Product NDC
63739-192
Requested package NDC
63739-192-10
11-digit product format
637390192
Labeler code
63739
Product ID
63739-192_b9e964c1-2163-0271-e053-2a95a90a5b54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2017-02-24
Marketing end
0000-00-00
Substance
PHENOBARBITAL
Active strength
16 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 packagepackage63739-19263739-192-10DDiscontinued by firm2026-10-15

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63739-19263739-192-10DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
63739-192-102024-02-12C16284748780-1ab0e2407-2d3f-f274-e053-dbdaa90a6471PHENOBARBITAL TABLETS, USP
63739-192-102024-01-30C16284748780-1ab0e2407-2d3f-f274-e053-dbdaa90a6471PHENOBARBITAL TABLETS, USP
63739-192-102020-07-22C16284748780-1ab0e2407-2d3f-f274-e053-dbdaa90a6471PHENOBARBITAL TABLETS, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-192-10EA - Each63739-192519563ad-293b-42c0-8d19-a49696ea087b12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-192PHENOBARBITAL TABLET [MCKESSON CORPORATION DBA SKY PACKAGING]8Legacy NDC20250308_0cefcc97-12f6-4774-88ad-152dcb9bef94.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-192-106373901921010 BLISTER PACK in 1 BOX (63739-192-10) > 10 TABLET in 1 BLISTER PACK10 blister pack2019-07-100000-00-00NoNoCurrent