NDC 59212-422

Donnatal

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide

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

Product ID59212-422_03afa114-a2a5-4c44-a651-b15ea2739a56
NDC59212-422
Product TypeHuman Prescription Drug
Proprietary NameDonnatal
Generic NamePhenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
Dosage FormElixir
Route of AdministrationORAL
Marketing Start Date1980-12-30
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameConcordia Pharmaceuticals Inc.
Substance NamePHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE
Active Ingredient Strength16 mg/5mL; mg/5mL; mg/5mL; mg/5mL
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 59212-422-04

118 mL in 1 BOTTLE (59212-422-04)
Marketing Start Date1980-12-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59212-422-11 [59212042211]

Donnatal ELIXIR
Marketing CategoryUNAPPROVED DRUG OTHER
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-28
Marketing End Date2017-02-08

NDC 59212-422-10 [59212042210]

Donnatal ELIXIR
Marketing CategoryUNAPPROVED DRUG OTHER
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1980-12-30

NDC 59212-422-12 [59212042212]

Donnatal ELIXIR
Marketing CategoryUNAPPROVED DRUG OTHER
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-28
Marketing End Date2017-02-08

NDC 59212-422-04 [59212042204]

Donnatal ELIXIR
Marketing CategoryUNAPPROVED DRUG OTHER
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1980-12-30

NDC 59212-422-16 [59212042216]

Donnatal ELIXIR
Marketing CategoryUNAPPROVED DRUG OTHER
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1980-12-30

Drug Details

Active Ingredients

IngredientStrength
PHENOBARBITAL16.2 mg/5mL

OpenFDA Data

SPL SET ID:4dba30db-7979-455f-a225-24f0a04d744e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1046787
  • 1046924
    • UPC Code
  • 0359212422040
  • 0359212423047

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Donnatal" or generic name "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide"

    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
    68151-0607DonnatalDonnatal
    66213-421Donnatal ExtentabsPhenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
    63629-2050Phenobarbital with Belladonna Alkaloidsphenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
    63629-2051Phenobarbital with Belladonna Alkaloids - Grapephenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
    63629-2052Phenobarbital with Belladonna Alkaloids - Mintphenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
    50742-665Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine HydrobromidePhenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
    50742-666Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine HydrobromidePhenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
    66993-118phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromidephenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
    66993-119phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromidephenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
    21695-970QUADRAPAXPhenobarbital, 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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