NDC 17856-0423

Donnatal

Phenobarbital

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

Product ID17856-0423_42d4c5a0-3af9-481f-b29e-813b66090ba1
NDC17856-0423
Product TypeHuman Prescription Drug
Proprietary NameDonnatal
Generic NamePhenobarbital
Dosage FormElixir
Route of AdministrationORAL
Marketing Start Date2009-11-01
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameAtlantic Biologicals Corps
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]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 17856-0423-2

15 mL in 1 CUP (17856-0423-2)
Marketing Start Date2009-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-0423-4 [17856042304]

Donnatal ELIXIR
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-26
Inactivation Date2020-01-31

NDC 17856-0423-8 [17856042308]

Donnatal ELIXIR
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-06
Inactivation Date2020-01-31

NDC 17856-0423-5 [17856042305]

Donnatal ELIXIR
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-11-01
Inactivation Date2020-01-31

NDC 17856-0423-9 [17856042309]

Donnatal ELIXIR
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-06
Inactivation Date2020-01-31

NDC 17856-0423-2 [17856042302]

Donnatal ELIXIR
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-01
Inactivation Date2020-01-31

NDC 17856-0423-3 [17856042303]

Donnatal ELIXIR
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-11-01
Inactivation Date2020-01-31

NDC 17856-0423-6 [17856042306]

Donnatal ELIXIR
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PHENOBARBITAL16.2 mg/5mL

OpenFDA Data

SPL SET ID:5d69ffc1-4608-4d73-ae91-838983bcf98d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1046787
  • 1046924

    • 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"

    NDCBrand NameGeneric Name
    68151-0607DonnatalDonnatal
    17856-0423DonnatalDonnatal
    42291-244DonnatalDonnatal
    42291-245DonnatalDonnatal
    42254-268DonnatalDonnatal
    59212-422DonnatalDonnatal
    59212-425DonnatalDonnatal
    59212-423DonnatalDonnatal
    65084-123DonnatalDonnatal
    66213-423DonnatalDonnatal
    66213-425DonnatalDonnatal
    66213-422DonnatalDonnatal
    66689-063DonnatalDonnatal
    0121-0531PhenobarbitalPhenobarbital
    0143-1445PhenobarbitalPhenobarbital
    0143-1450PhenobarbitalPhenobarbital
    0143-1455PhenobarbitalPhenobarbital
    0143-1458PhenobarbitalPhenobarbital
    0143-1495PhenobarbitalPhenobarbital
    0143-1500PhenobarbitalPhenobarbital
    0463-6145PhenobarbitalPhenobarbital
    0463-6151PhenobarbitalPhenobarbital
    0463-6160PhenobarbitalPhenobarbital
    0463-6170PhenobarbitalPhenobarbital
    0603-1508Phenobarbitalphenobarbital
    0603-5165Phenobarbitalphenobarbital
    0603-5166Phenobarbitalphenobarbital
    0603-5167Phenobarbitalphenobarbital
    0603-5168Phenobarbitalphenobarbital
    0904-6575Phenobarbitalphenobarbital
    13517-107Phenobarbitalphenobarbital
    13517-110Phenobarbitalphenobarbital

    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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