FDA.reportPublic FDA data

Phenobarbital

Product NDC
43063-953
11-digit product format
430630953
Labeler code
43063
Product ID
43063-953_e6db88e4-fc21-090f-e053-2a95a90af0ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2017-02-24
Marketing end
0000-00-00
Substance
PHENOBARBITAL
Active strength
32 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43063-953DDiscontinued by firm2026-10-05
excluded packagepackage43063-95343063-953-30DDiscontinued by firm2026-10-05

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 · 2 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 productproduct43063-953DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-95343063-953-30DDiscontinued 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-953-30EA - Each43063-9537f1fe5bc-cf97-4298-8f20-110aeb32d3b712019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-953PHENOBARBITAL TABLET [PD-RX PHARMACEUTICALS, INC.]12Legacy NDC20241018_5d567cef-2480-416b-b4e4-a2e3cb205e9a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-953-304306309533030 TABLET in 1 BOTTLE, PLASTIC (43063-953-30) 30 tablet2019-03-060000-00-00NoNoCurrent