NDC 17856-0087

Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release

Hydrocodone Polistirex And Chlorpheniramine Polistirex

Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release is a Oral Suspension, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Atlantic Biologicals Corp.. The primary component is Chlorpheniramine Maleate; Hydrocodone Bitartrate.

• Product ID: 17856-0087_006b0771-3a21-4603-bf6b-dcd19abb29ca
• NDC: 17856-0087
• Product Type: Human Prescription Drug
• Proprietary Name: Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release
• Generic Name: Hydrocodone Polistirex And Chlorpheniramine Polistirex
• Dosage Form: Suspension, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2015-03-06
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091632
• Labeler Name: ATLANTIC BIOLOGICALS CORP.
• Substance Name: CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE
• Active Ingredient Strength: 8 mg/5mL; mg/5mL
• Pharm Classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2024-12-31

Packaging

NDC 17856-0087-2

1 BOX, UNIT-DOSE in 1 CUP, UNIT-DOSE (17856-0087-2) > 5 BOX, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0087-3) > 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0087-1) > 5 mL in 1 CUP, UNIT-DOSE

• Marketing Start Date: 2023-01-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 17856-0087-1 [17856008701]

Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release SUSPENSION, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA091632
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-09-27

Drug Details

Active Ingredients

Ingredient	Strength
HYDROCODONE BITARTRATE	10 mg/5mL

OpenFDA Data

• SPL SET ID: 9445fb20-9601-44e8-ac08-b27e1e214755
• Manufacturer:
  • ATLANTIC BIOLOGICALS CORP.
• UNII:
  • V1Q0O9OJ9Z
  • NO70W886KK
• RxNorm Concept Unique ID - RxCUI:
  • 1087459

Pharmacological Class

• Opioid Agonist [EPC]
• Opioid Agonists [MoA]
• Histamine H1 Receptor Antagonists [MoA]
• Histamine-1 Receptor Antagonist [EPC]
• Opioid Agonist [EPC]
• Opioid Agonists [MoA]
• Histamine H1 Receptor Antagonists [MoA]
• Histamine-1 Receptor Antagonist [EPC]

NDC Crossover Matching brand name "Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release" or generic name "Hydrocodone Polistirex And Chlorpheniramine Polistirex"

NDC	Brand Name	Generic Name
17856-0087	Hydrocodone Polistirex and Chlorpheniramine Polistirex	Hydrocodone Polistirex and Chlorpheniramine Polistirex
17856-0301	Hydrocodone Polistirex and Chlorpheniramine Polistirex	Hydrocodone Polistirex and Chlorpheniramine Polistirex
27808-086	Hydrocodone Polistirex and Chlorpheniramine Polistirex	Hydrocodone Polistirex and Chlorpheniramine Polistirex
62542-301	Hydrocodone Polistirex and Chlorpheniramine Polistirex	Hydrocodone Polistirex and Chlorpheniramine Polistirex
63629-2303	Hydrocodone Polistirex and Chlorpheniramine Polistirex	Hydrocodone Polistirex and Chlorpheniramine Polistirex
63629-2304	Hydrocodone Polistirex and Chlorpheniramine Polistirex	Hydrocodone Polistirex and Chlorpheniramine Polistirex
62175-490	Hydrocodone Polistirex and Chlorpheniramine Polistirex Pennkinetic	hydrocodone polistirex and chlorpheniramine polistirex
0187-0108	TussiCaps	hydrocodone polistirex and chlorpheniramine polistirex
53014-548	Tussionex Pennkinetic	hydrocodone polistirex and chlorpheniramine polistirex