NDC 0187-0108

TussiCaps

Hydrocodone Polistirex And Chlorpheniramine Polistirex

TussiCaps is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Valeant Pharmaceuticals North America Llc. The primary component is Hydrocodone; Chlorpheniramine.

• Product ID: 0187-0108_2524519a-8e01-4c69-8459-8c9d25755120
• NDC: 0187-0108
• Product Type: Human Prescription Drug
• Proprietary Name: TussiCaps
• Generic Name: Hydrocodone Polistirex And Chlorpheniramine Polistirex
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2011-09-02
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077273
• Labeler Name: VALEANT PHARMACEUTICALS NORTH AMERICA LLC
• Substance Name: HYDROCODONE; CHLORPHENIRAMINE
• Active Ingredient Strength: 10 mg/1; mg/1
• Pharm Classes: Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0187-0108-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0187-0108-01)

• Marketing Start Date: 2011-09-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0187-0108-20 [00187010820]

TussiCaps CAPSULE, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA077273
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-09-02

NDC 0187-0108-01 [00187010801]

TussiCaps CAPSULE, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA077273
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-09-02

Drug Details

Active Ingredients

Ingredient	Strength
HYDROCODONE	10 mg/1

OpenFDA Data

• SPL SET ID: 571c1b83-2fde-4339-be0c-cac0dedaf76c
• Manufacturer:
  • VALEANT PHARMACEUTICALS NORTH AMERICA LLC
• UNII:
  • 6YKS4Y3WQ7
  • 3U6IO1965U
• RxNorm Concept Unique ID - RxCUI:
  • 1087389
  • 857510
  • 1087427
  • 857512

Pharmacological Class

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

NDC Crossover Matching brand name "TussiCaps" or generic name "Hydrocodone Polistirex And Chlorpheniramine Polistirex"

NDC	Brand Name	Generic Name
0187-0108	TussiCaps	hydrocodone polistirex and chlorpheniramine polistirex
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
53014-548	Tussionex Pennkinetic	hydrocodone polistirex and chlorpheniramine polistirex