NDC 42291-244

Donnatal

Phenobarbital Elixir

Donnatal is a Oral Elixir in the Human Prescription Drug category. It is labeled and distributed by Avkare, Inc.. The primary component is Phenobarbital; Hyoscyamine Sulfate; Scopolamine Hydrobromide; Atropine Sulfate.

Product ID42291-244_625eed7a-4db1-6378-e053-2a91aa0a4145
NDC42291-244
Product TypeHuman Prescription Drug
Proprietary NameDonnatal
Generic NamePhenobarbital Elixir
Dosage FormElixir
Route of AdministrationORAL
Marketing Start Date2014-01-13
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameAvKARE, Inc.
Substance NamePHENOBARBITAL; HYOSCYAMINE SULFATE; SCOPOLAMINE HYDROBROMIDE; ATROPINE SULFATE
Active Ingredient Strength16 mg/5mL; mg/5mL; mg/5mL; mg/5mL
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 42291-244-04

118 mL in 1 BOTTLE (42291-244-04)
Marketing Start Date2014-02-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42291-244-16 [42291024416]

Donnatal ELIXIR
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-02-04

NDC 42291-244-04 [42291024404]

Donnatal ELIXIR
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-02-04

Drug Details

Active Ingredients

IngredientStrength
PHENOBARBITAL16.2 mg/5mL

OpenFDA Data

SPL SET ID:85c207ad-83bb-20e8-ef73-9a374eb8ccb6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1046787
  • 1046924
    • UPC Code
  • 0342291244047

    • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]
    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]
    • Cholinergic Muscarinic Antagonist [EPC]
    • Cholinergic Muscarinic Antagonists [MoA]

    NDC Crossover Matching brand name "Donnatal" or generic name "Phenobarbital Elixir"

    NDCBrand NameGeneric Name
    17856-0423DonnatalPHENOBARBITAL
    42254-268DonnatalPhenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
    42291-244Donnatalphenobarbital elixir
    42291-245DonnatalPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE
    59212-422Donnatalphenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
    59212-423Donnatalphenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
    59212-425DonnatalPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE
    65084-123DonnatalPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE
    66213-422DonnatalPHENOBARBITAL ELIXIR
    66213-423DonnatalPHENOBARBITAL ELIXIR
    66213-425DonnatalPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE
    66689-063Donnatalphenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
    68151-0607DonnatalPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE

    Trademark Results [Donnatal]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DONNATAL
    DONNATAL
    71377644 0338733 Live/Registered
    A. H. ROBINS COMPANY, INC.
    1936-04-25
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