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 ID: 21695-594_4de8df82-23db-421b-8531-c755854b3e5e
• NDC: 21695-594
• Product Type: Human Prescription Drug
• Proprietary Name: RE-PB HYOS ELIXIR
• Generic Name: Belladonna Alkaloids W/ Phenobarbital
• Dosage Form: Elixir
• Route of Administration: ORAL
• Marketing Start Date: 2009-10-20
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Rebel Distributors Corp
• Substance Name: PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE
• Active Ingredient Strength: 16 mg/5mL; mg/5mL; mg/5mL; mg/5mL
• Pharm Classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA]
• DEA Schedule: CIV
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 21695-594-16

480 mL in 1 BOTTLE (21695-594-16)

• Marketing Start Date: 2009-10-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 21695-594-16 [21695059416]

RE-PB HYOS ELIXIR ELIXIR

• Marketing Category: Unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-10-20
• Inactivation Date: 2019-09-24

Drug Details

Active Ingredients

Ingredient	Strength
PHENOBARBITAL	16.2 mg/5mL

OpenFDA Data

• SPL SET ID: 4de8df82-23db-421b-8531-c755854b3e5e
• Manufacturer:
  • Rebel Distributors Corp
• UNII:
  • YQE403BP4D
  • 451IFR0GXB
  • 03J5ZE7KA5
  • F2R8V82B84
• 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]