FDA.reportPublic FDA data

PHENOBARBITAL SODIUM - Food and Drug Administration

Set ID
e3e67a66-d325-4d80-8f9d-059e736d7b00
Type
Indexing - product concept
Effective date
2023-09-12
Version
1
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
PHENOBARBITAL TABLETS, USP CIVProduct nameREMEDYREPACK INC.2026-09-02
PHENOBARBITAL TABLETS, USP CIVProduct nameREMEDYREPACK INC.2026-08-31
PHENOBARBITAL TABLETS, USPProduct nameSun Pharmaceutical Industries, Inc. | Genus Lifesciences Inc.2026-07-14
PHENOBARBITAL TABLETS, USP CIVProduct nameREMEDYREPACK INC.2026-07-07
FIDOQUEL™-CA1 (phenobarbital tablets)Product nameGenus Lifesciences2026-06-01
PHENOHYTRO ® ELIXIRProduct nameATLANTIC BIOLOGICALS CORP.2026-05-19
Phenobarbital Tablets, USP CIV Rx onlyProduct nameMajor Pharmaceuticals2026-04-30
PHENOBARBITAL TABLETS, USP CIVProduct nameGenus Lifesciences2026-04-17
PHENOBARBITAL TABLETS, USPProduct nameWestminster Pharmaceuticals, LLC2026-03-12
PHENOBARBITAL TABLETS, USP CIVProduct nameClinical Solutions Wholesale, LLC2026-03-04
Phenobarbital Oral Solution USP, CIVProduct nameChartwell Governmental & Specialty RX, LLC.2026-02-25
Phenobarbital Oral Solution, USP CIVProduct nameBPI Labs LLC | AJENAT PHARMACEUTICALS LLC2025-12-29
Phenobarbital Oral Solution, USP CIVProduct nameAjenat Pharmaceuticals LLC2025-12-29
These highlights do not include all the information needed to use SEZABY safely and effectively. See full prescribing information for SEZABY. SEZABY™ (phenobarbital sodium) for injection, for intravenous use, CIV Initial U.S. Approval: 2022Product nameSun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Medicare Limited2025-12-23
PHENOBARBITAL TABLETS, USP CIVProduct nameRedpharm Drug2025-12-18
Phenobarbital Sodium Injection, USP CIV FOR IM OR SLOW IV ADMINISTRATION ONLY DO NOT USE IF SOLUTION IS DISCOLORED OR CONTAINS A PRECIPITATE Rx onlyProduct nameBPI Labs LLC2025-12-17
Nexus Pharmaceuticals, LLC human prescription drug labelProduct nameNexus Pharmaceuticals, LLC2025-12-12
PHENOBARBITAL TABLETS, USP CIV Rx only WARNING: MAY BE HABIT-FORMINGProduct nameChartwell RX, LLC2025-12-11
PHENOBARBITAL TABLETS, USP CIVProduct nameWestminster Pharmaceuticals, LLC2025-12-01
Phenobarbital Oral Solution, USP CIV Rx OnlyProduct nameKesin Pharma Corporation2025-11-25
Phenobarbital Tablets, USP CIV Rx onlyProduct nameMajor Pharmaceuticals2025-11-10
Phenobarbital Oral Solution, USP CIVProduct nameAjenat Pharmaceuticals LLC2025-11-05
Phenobarbital Sodium Injection, USPProduct nameBryant Ranch Prepack2025-11-05
Phenobarbital Sodium Injection, USPProduct nameBryant Ranch Prepack2025-11-05
PHENOBARBITAL TABLETS, USP CIVProduct nameREMEDYREPACK INC.2025-09-29
PHENOBARBITAL TABLETS, USPProduct namePD-Rx Pharmaceuticals, Inc.2025-09-25
PHENOBARBITAL TABLETS, USP CIVProduct nameREMEDYREPACK INC.2025-09-25
PHENOBARBITAL ELIXIR, USP CIV Rx onlyProduct nameTrigen Laboratories, LLC2025-09-22
PHENOBARBITAL TABLETS, USP CIV Rx OnlyProduct nameTrigen Laboratories, LLC2025-09-22
PHENOBARBITAL TABLETS, USP CIV Rx Only WARNING: MAY BE HABIT FORMINGProduct nameTrigen Laboratories, LLC2025-09-22
Phenobarbital Oral Solution, USP CIVProduct nameKesin Pharma Corporation2025-09-03
Phenobarbital Sodium Injection, USPProduct nameBryant Ranch Prepack2025-08-18
Phenobarbital Sodium Injection, USPProduct nameBryant Ranch Prepack2025-08-18
Phenobarbital Sodium Injection, USPProduct nameBryant Ranch Prepack2025-08-18
PHENOBARBITAL ELIXIR, USP CIV Rx onlyProduct namee5 Pharma, LLC2025-07-31
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct namee5 Pharma, LLC2025-07-31
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct namee5 Pharma, LLC2025-07-31
Phenobarbital Sodium Injection, USPProduct nameBryant Ranch Prepack2025-07-29
Phenobarbital Sodium Injection, USPProduct nameBryant Ranch Prepack2025-07-29
Phenobarbital Elixir, USP IV Rx Only 8467167/0322FProduct nameAmerican Health Packaging2025-07-10
PHENOBARBITAL TABLETS, USP CIV Rx Only Rev. Jan 2022Product nameCoupler LLC2025-07-02
Phenobarbital Sodium Injection, USPProduct nameBryant Ranch Prepack2025-06-10
Phenobarbital Sodium Injection, USPProduct nameCameron Pharmaceuticals | Vitae Enim Vitae Scientific, Inc.2025-06-04
Phenobarbital Sodium Injection, USPProduct nameCameron Pharmaceuticals | Vitae Enim Vitae Scientific, Inc.2025-06-04
PHENOBARBITAL Elixir, USP CIVProduct nameWestminster Pharmaceuticals, LLC2025-05-08
FIDOQUEL™-CA1 (phenobarbital tablets)Product nameGenus Lifesciences2025-04-10
PHENOBARBITAL TABLETS, USP CIV Rx Only Rev. Jan 2022Product nameCoupler LLC2025-03-26
Phenobarbital Oral Solution USP, CIVProduct nameChartwell RX, LLC | Chartwell Pharmaceuticals Carmel, LLC2025-03-14
PHENOBARBITAL TABLETS, USPProduct nameMcKesson Corporation dba SKY Packaging | Legacy Pharmaceutical Packaging, LLC2025-03-05
PHENOBARBITAL TABLETS, USP CIVProduct nameProficient Rx LP2025-03-01
PHENOBARBITAL ORAL SOLUTION, USP CIVProduct nameBioRamo, LLC2024-12-18
DONNATAL® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Elixir Rx Only Revised: 11/23Product nameAdvanz Pharma (US) Corp.2024-12-05
DONNATAL® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Tablets Rx Only Revised: 11/23Product nameAdvanz Pharma (US) Corp.2024-12-05
Phenobarbital Oral Solution USP, CIVProduct namePAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma2024-11-19
PHENOBARBITAL ELIXIR, USP CIV Rx onlyProduct nameLaser Pharmaceuticals, LLC2024-10-11
Phenobarbital Tablets, USP CIV Rx onlyProduct nameBryant Ranch Prepack2024-10-10
Phenobarbital Tablets, USP CIV Rx onlyProduct nameBryant Ranch Prepack2024-10-04
Phenobarbital Tablets, USP CIV Rx onlyProduct nameBryant Ranch Prepack2024-10-04
Phenobarbital Tablets, USP CIV Rx onlyProduct nameBryant Ranch Prepack2024-10-04
PHENOBARBITAL TABLETS, USP CIVProduct nameProficient Rx LP2024-10-01
Phenobarbital Sodium Injection, USPProduct nameBryant Ranch Prepack2024-09-06
PHENOBARBITAL ORAL SOLUTION, USP CIVProduct nameBryant Ranch Prepack2024-08-20
Phenobarbital Tablets, USP CIV Rx onlyProduct namePar Health USA, LLC | Generics Bidco II LLC d/b/a Prinston Laboratories2024-08-20
PHENOBARBITAL 32.4mg TABLETSProduct nameRedPharm Drug, Inc. | RedPharm Drug2024-08-07
PHENOBARBITAL TABLETS, USPProduct nameTaro Pharmaceuticals U.S.A. Inc. | Genus Lifesciences Inc.2024-07-30
PHENOBARBITAL TABLETS, USP CIV Rx OnlyProduct nameHikma Pharmaceuticals USA Inc.2024-07-30
Phenobarbital Sodium Injection, USP CIV FOR IM OR SLOW IV ADMINISTRATION DO NOT USE IF SOLUTION IS DISCOLORED OR CONTAINS A PRECIPITATE Rx onlyProduct nameHikma Pharmaceuticals USA Inc.2024-04-10
PHENOBARBITAL TABLETS, USP C-IV Rx only WARNING: MAY BE HABIT-FORMINGProduct nameBryant Ranch Prepack2024-03-28
PHENOBARBITAL TABLETS, USP CIVProduct nameProficient Rx LP2024-03-01
PHENOBARBITAL TABLETS, USP C-IV Rx only WARNING: MAY BE HABIT-FORMINGProduct nameBryant Ranch Prepack2024-02-07
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct nameBryant Ranch Prepack2024-02-07
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct nameBryant Ranch Prepack2024-02-07
PHENOBARBITAL TABLETS, USP C-IV Rx only WARNING: MAY BE HABIT-FORMINGProduct nameBryant Ranch Prepack2024-01-11
PHENOBARBITAL TABLETS, USP C-IV Rx only WARNING: MAY BE HABIT-FORMINGProduct nameBryant Ranch Prepack2024-01-11
PHENOBARBITAL TABLETS, USP C-IV Rx only WARNING: MAY BE HABIT-FORMINGProduct nameBryant Ranch Prepack2024-01-11
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct nameClinical Solutions Wholesale, LLC2024-01-09
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct nameBryant Ranch Prepack2024-01-09
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct nameClinical Solutions Wholesale, LLC2024-01-09
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct nameBryant Ranch Prepack2024-01-09
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct nameBryant Ranch Prepack2024-01-09
PHENOBARBITAL TABLETS, USP C-IV Rx only WARNING: MAY BE HABIT-FORMINGProduct nameBryant Ranch Prepack2023-12-08
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct nameBryant Ranch Prepack2023-12-08
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct nameBryant Ranch Prepack2023-12-08
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct nameBryant Ranch Prepack2023-12-08
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct nameBryant Ranch Prepack2023-12-08
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct nameBryant Ranch Prepack2023-10-20
PHENOBARBITAL ORAL SOLUTION, USP CIVProduct nameWestminster Pharmaceuticals, LLC2023-10-12
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct nameBryant Ranch Prepack2023-10-09
PHENOBARBITAL TABLETS, USP C-IV Rx only WARNING: MAY BE HABIT-FORMINGProduct nameBryant Ranch Prepack2023-09-13
PHENOBARBITAL TABLETS, USP CIVProduct nameWestminster Pharmaceuticals, LLC2023-09-13
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct nameBryant Ranch Prepack2023-08-30
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct nameBryant Ranch Prepack2023-08-30
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct nameBryant Ranch Prepack2023-08-30
PHENOBARBITAL ORAL SOLUTION, USP CIVProduct nameBryant Ranch Prepack2023-08-29
PHENOBARBITAL ORAL SOLUTION, USP CIVProduct nameATLANTIC BIOLOGICALS CORP2023-04-18
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct nameBryant Ranch Prepack2023-03-01
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct nameBryant Ranch Prepack2023-03-01
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct nameBryant Ranch Prepack2023-03-01
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct nameBryant Ranch Prepack2023-03-01
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct nameBryant Ranch Prepack2023-03-01
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct nameBryant Ranch Prepack2023-03-01
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct nameBryant Ranch Prepack2023-03-01
PHENOBARBITAL TABLETS, USP C-IV Rx only WARNING: MAY BE HABIT-FORMINGProduct nameBryant Ranch Prepack2023-02-27
PHENOBARBITAL TABLETS, USP CIV Rx onlyProduct nameBryant Ranch Prepack2023-02-21
PHENOBARBITAL TABLETS, USP C-IV Rx onlyProduct nameQUAGEN PHARMACEUTICALS LLC2023-02-16
PHENOBARBITAL TABLETS, USP C-IV Rx onlyProduct nameQUAGEN PHARMACEUTICALS LLC2023-02-16
PHENOBARBITAL ORAL SOLUTION, USP CIV Rx onlyProduct nameQUAGEN PHARMACEUTICALS LLC2023-02-02
PHENOBARBITAL TABLETS, USP C-IV Rx only WARNING: MAY BE HABIT-FORMINGProduct nameProficient Rx LP2023-02-01
PHENOBARBITAL TABLETS, USP C-IV Rx Only WARNING: MAY BE HABIT-FORMINGProduct nameProficient Rx LP2023-02-01
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir Rx Only Revised: 05/21Product nameIngenus Pharmaceuticals, LLC2023-01-12
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets Rx Only Revised: 05/21Product nameIngenus Pharmaceuticals, LLC2023-01-10
PHENOBARBITAL TABLETS, USP C-IV Rx Only WARNING: MAY BE HABIT-FORMINGProduct nameProficient Rx LP2022-08-01
DONNATAL® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Elixir Rx OnlyProduct nameVistaPharm, LLC2022-07-07
PHENOBARBITAL TABLETS, USP CIV Rx Only Rev. Jan 2022Product nameWINDER LABORATORIES, LLC2022-05-31
PHENOBARBITAL ELIXIR, USP CIV Rx onlyProduct nameStrides Pharma Science Limited | Strides Pharma Global Pte. Ltd. | Strides Pharma, Inc2022-04-06
PHENOBARBITAL ORAL SOLUTION, USP CIVProduct nameBioRamo, LLC2022-03-03
Phenobarbital Oral Solution USP CIVProduct namePharmaceutical Associates, Inc.2022-01-05
PHENOBARBITAL ORAL SOLUTION, USP CIVProduct nameATLANTIC BIOLOGICALS CORP.2021-01-22
PHENOHYTRO ® ELIXIRProduct nameATLANTIC BIOLOGICALS CORP.2021-01-12
PHENOBARBITAL ORAL SOLUTION, USP CIVProduct nameRising Pharma Holdings, Inc. | QUAGEN PHARMACEUTICALS LLC2020-09-15