NDC 66689-063

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 Vistapharm, Inc.. The primary component is Phenobarbital; Hyoscyamine Sulfate; Atropine Sulfate; Scopolamine Hydrobromide.

Product ID66689-063_24b0447b-4a23-4039-bf76-066bc78a1438
NDC66689-063
Product TypeHuman Prescription Drug
Proprietary NameDonnatal
Generic NamePhenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
Dosage FormElixir
Route of AdministrationORAL
Marketing Start Date2017-10-26
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameVistaPharm, 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 Through2022-12-31

Packaging

NDC 66689-063-10

1 TRAY in 1 CASE (66689-063-10) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (66689-063-01)
Marketing Start Date2017-10-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66689-063-40 [66689006340]

Donnatal ELIXIR
Marketing CategoryUNAPPROVED DRUG OTHER
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-26

NDC 66689-063-50 [66689006350]

Donnatal ELIXIR
Marketing CategoryUNAPPROVED DRUG OTHER
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-26

NDC 66689-063-10 [66689006310]

Donnatal ELIXIR
Marketing CategoryUNAPPROVED DRUG OTHER
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-10-26

NDC 66689-063-01 [66689006301]

Donnatal ELIXIR
Marketing CategoryUNAPPROVED DRUG OTHER
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-10-26

NDC 66689-063-99 [66689006399]

Donnatal ELIXIR
Marketing CategoryUNAPPROVED DRUG OTHER
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-26

Drug Details

Active Ingredients

IngredientStrength
PHENOBARBITAL16.2 mg/5mL

OpenFDA Data

SPL SET ID:11a48ba9-576b-4e8c-9536-6e83636d6930
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1046787
  • 1046924

    • 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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