FDA.reportPublic FDA data

Phenobarbital

Product NDC
17856-0174
Requested package NDC
17856-0174-2
11-digit product format
178560174
Labeler code
17856
Product ID
17856-0174_067033dc-f5d1-415d-92a2-195ca97982e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
ELIXIR
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2019-07-08
Marketing end
0000-00-00
Substance
PHENOBARBITAL
Active strength
20 mg/5mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage17856-017417856-0174-2DDiscontinued 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 · 5 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
17856-0174-12024-06-05PHENOBARBITAL Elixir, USP CIV
17856-0174-22024-06-05PHENOBARBITAL Elixir, USP CIV
17856-0174-32024-06-05PHENOBARBITAL Elixir, USP CIV
17856-0174-12024-01-30PHENOBARBITAL Elixir, USP CIV
17856-0174-22024-01-30PHENOBARBITAL Elixir, USP CIV
17856-0174-32024-01-30PHENOBARBITAL Elixir, USP CIV

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0174-1ML - Milliliter17856-017440a76ada-db76-4255-93bd-18277881b54712023-05-05
17856-0174-4ML - Milliliter17856-0174a877b781-9856-4b64-9abd-d3691794ed0f12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0174PHENOBARBITAL ELIXIR [ATLANTIC BIOLOGICALS CORP]3Legacy NDC20240606_5125763c-8b97-4192-902c-9d501e4e7ef0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17856-0174-21785601740272 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0174-2) > 7.5 mL in 1 CUP, UNIT-DOSE (17856-0174-5) 2022-02-070000-00-00NoNoCurrent