NDC 66213-421

Donnatal Extentabs

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide

Donnatal Extentabs is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Pbm Pharmaceuticals, Inc. The primary component is Phenobarbital; Hyoscyamine Sulfate; Atropine Sulfate; Scopolamine Hydrobromide.

Product ID66213-421_03a3609f-520f-4e7b-8d7b-1652881723c0
NDC66213-421
Product TypeHuman Prescription Drug
Proprietary NameDonnatal Extentabs
Generic NamePhenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2008-05-07
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NamePBM Pharmaceuticals, Inc
Substance NamePHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE
Active Ingredient Strength49 mg/1; mg/1; mg/1; mg/1
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 66213-421-10

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (66213-421-10)
Marketing Start Date2008-05-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66213-421-10 [66213042110]

Donnatal Extentabs TABLET, FILM COATED, EXTENDED RELEASE
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-05-07
Inactivation Date2020-01-31

NDC 66213-421-50 [66213042150]

Donnatal Extentabs TABLET, FILM COATED, EXTENDED RELEASE
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-05-07
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PHENOBARBITAL48.6 mg/1

OpenFDA Data

SPL SET ID:2064014b-6f8e-4232-88c2-d1870042abc7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1046999
  • 1046997
    • UPC Code
  • 0366213421507
  • 0366213421101

    • 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 Extentabs" or generic name "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide"

    NDCBrand NameGeneric Name
    66213-421Donnatal ExtentabsPhenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
    42254-268DonnatalPhenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
    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
    66213-425DonnatalPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE
    66689-063Donnatalphenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
    68151-0607DonnatalPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE
    63629-2050Phenobarbital with Belladonna Alkaloidsphenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
    72768-7010Phenobarbital with Belladonna Alkaloidsphenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
    63629-2051Phenobarbital with Belladonna Alkaloids - Grapephenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
    72768-9011Phenobarbital 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 Extentabs]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DONNATAL EXTENTABS
    DONNATAL EXTENTABS
    72167940 0768358 Dead/Cancelled
    A. H. Robins Company, Inc.
    1963-05-01
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.