FDA.reportPublic FDA data

Phenobarbital

Product NDC
16571-330
11-digit product format
165710330
Labeler code
16571
Product ID
16571-330_16a21d06-8b1d-4f87-a957-37a46cfcd5a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
LIQUID
Route
ORAL
Labeler
Rising Pharmaceuticals, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2016-06-10
Marketing end
2020-10-31
Substance
PHENOBARBITAL
Active strength
20 mg/5mL
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct16571-330DDiscontinued by firm2026-10-05
excluded packagepackage16571-33016571-330-16DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage16571-330-16d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage16571-330-16f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage16571-330-162ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage16571-330-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage16571-330-16cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage16571-330-16cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage16571-330-16302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage16571-330-16ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage16571-330-160efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16571-330-16ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16571-330-16367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16571-330-16557ba5c1ecfa…9c80585c8c6e…

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
16571-330-16ML - Milliliter16571-3308b863f95-7f7f-4f05-bfd9-a1e409a3f3e012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PhenobarbitalACTIVE INGREDIENTYQE403BP4DPHENOBARBITAL LIQUID [PACK PHARMACEUTICALS, LLC]1
PhenobarbitalACTIVE MOIETYYQE403BP4DPHENOBARBITAL LIQUID [PACK PHARMACEUTICALS, LLC]1
alcoholINACTIVE INGREDIENT3K9958V90MPHENOBARBITAL LIQUID [PACK PHARMACEUTICALS, LLC]1
FD&C Red no. 40INACTIVE INGREDIENTWZB9127XOAPHENOBARBITAL LIQUID [PACK PHARMACEUTICALS, LLC]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXPHENOBARBITAL LIQUID [PACK PHARMACEUTICALS, LLC]1
OrangeINACTIVE INGREDIENT5EVU04N5QUPHENOBARBITAL LIQUID [PACK PHARMACEUTICALS, LLC]1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYPHENOBARBITAL LIQUID [PACK PHARMACEUTICALS, LLC]1
SorbitolINACTIVE INGREDIENT506T60A25RPHENOBARBITAL LIQUID [PACK PHARMACEUTICALS, LLC]1
WaterINACTIVE INGREDIENT059QF0KO0RPHENOBARBITAL LIQUID [PACK PHARMACEUTICALS, LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702519PHENobarbital 20 MG in 5 mL Oral SolutionPSN65c41274-a2ef-369a-e053-2a91aa0aa6a31
702519phenobarbital 4 MG/ML Oral SolutionSCD65c41274-a2ef-369a-e053-2a91aa0aa6a31
702519phenobarbital 20 MG per 5 ML Oral SolutionSY65c41274-a2ef-369a-e053-2a91aa0aa6a31
702519phenobarbital 30 MG per 7.5 ML Oral SolutionSY65c41274-a2ef-369a-e053-2a91aa0aa6a31
702519phenobarbital 60 MG per 15 ML Oral SolutionSY65c41274-a2ef-369a-e053-2a91aa0aa6a31