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 |