NDC 21695-594

RE-PB HYOS ELIXIR

Belladonna Alkaloids W/ Phenobarbital

RE-PB HYOS ELIXIR is a Oral Elixir in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Phenobarbital; Hyoscyamine Sulfate; Atropine Sulfate; Scopolamine Hydrobromide.

Product ID21695-594_4de8df82-23db-421b-8531-c755854b3e5e
NDC21695-594
Product TypeHuman Prescription Drug
Proprietary NameRE-PB HYOS ELIXIR
Generic NameBelladonna Alkaloids W/ Phenobarbital
Dosage FormElixir
Route of AdministrationORAL
Marketing Start Date2009-10-20
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameRebel Distributors Corp
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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-594-16

480 mL in 1 BOTTLE (21695-594-16)
Marketing Start Date2009-10-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-594-16 [21695059416]

RE-PB HYOS ELIXIR ELIXIR
Marketing CategoryUnapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-10-20
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
PHENOBARBITAL16.2 mg/5mL

OpenFDA Data

SPL SET ID:4de8df82-23db-421b-8531-c755854b3e5e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1046787
  • Pharmacological Class

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

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