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 Tris Pharma Inc. The primary component is Hydrocodone Bitartrate; Chlorpheniramine Maleate.
Product ID | 27808-086_68aacf08-9d3b-41ae-a72c-8129ef090991 |
NDC | 27808-086 |
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 | Tris Pharma Inc |
Substance Name | HYDROCODONE BITARTRATE; CHLORPHENIRAMINE MALEATE |
Active Ingredient Strength | 10 mg/5mL; mg/5mL |
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 | 2022-12-31 |
Marketing Start Date | 2015-03-06 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA091632 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2019-10-01 |
Marketing Category | ANDA |
Application Number | ANDA091632 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2015-03-06 |
Marketing Category | ANDA |
Application Number | ANDA091632 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2015-03-06 |
Ingredient | Strength |
---|---|
HYDROCODONE BITARTRATE | 10 mg/5mL |
SPL SET ID: | 25f400d9-1d6e-4d38-8f0d-98d471eba73b |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI | |
UPC Code |
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 |