NDC 72768-9011

Phenobarbital with Belladonna Alkaloids - Grape

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide

Phenobarbital with Belladonna Alkaloids - Grape is a Oral Elixir in the Human Prescription Drug category. It is labeled and distributed by Apothecon Florida, Llc. The primary component is Phenobarbital; Hyoscyamine Sulfate; Atropine Sulfate; Scopolamine Hydrobromide.

Product ID72768-9011_1fd77e63-b615-4eb8-8ae0-71df2d385671
NDC72768-9011
Product TypeHuman Prescription Drug
Proprietary NamePhenobarbital with Belladonna Alkaloids - Grape
Generic NamePhenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
Dosage FormElixir
Route of AdministrationORAL
Marketing Start Date2020-04-11
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameApothecon Florida, LLC
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 72768-9011-4

118 mL in 1 BOTTLE (72768-9011-4)
Marketing Start Date2020-04-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72768-9011-6 [72768901106]

Phenobarbital with Belladonna Alkaloids - Grape ELIXIR
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-11

NDC 72768-9011-4 [72768901104]

Phenobarbital with Belladonna Alkaloids - Grape ELIXIR
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-11

Drug Details

Active Ingredients

IngredientStrength
PHENOBARBITAL16.2 mg/5mL

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 "Phenobarbital with Belladonna Alkaloids - Grape" or generic name "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide"

NDCBrand NameGeneric Name
63629-2051Phenobarbital with Belladonna Alkaloids - Grapephenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
72768-9011Phenobarbital with Belladonna Alkaloids - Grapephenobarbital, 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
66213-421Donnatal ExtentabsPhenobarbital, 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
63629-2052Phenobarbital 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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.