Hydrocodone Polistirex and Chlorpheniramine Polistirex is a Oral Suspension, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Atlantic Biologicals Corps. The primary component is Hydrocodone; Chlorpheniramine.
Product ID | 17856-0301_d6f4aadf-6381-439e-99a3-ac9fdde39a0c |
NDC | 17856-0301 |
Product Type | Human Prescription Drug |
Proprietary Name | Hydrocodone Polistirex and Chlorpheniramine Polistirex |
Generic Name | Hydrocodone Polistirex And Chlorpheniramine Polistirex |
Dosage Form | Suspension, Extended Release |
Route of Administration | ORAL |
Marketing Start Date | 2014-10-23 |
Marketing Category | ANDA / ANDA |
Application Number | ANDA091671 |
Labeler Name | Atlantic Biologicals Corps |
Substance Name | HYDROCODONE; CHLORPHENIRAMINE |
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 | E |
Listing Certified Through | 2018-12-31 |
Marketing Start Date | 2016-11-29 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA091671 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2017-03-29 |
Marketing End Date | 2017-06-16 |
Marketing Category | ANDA |
Application Number | ANDA091671 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2016-11-29 |
Inactivation Date | 2020-01-31 |
Ingredient | Strength |
---|---|
HYDROCODONE | 10 mg/5mL |
SPL SET ID: | 616633d3-66b8-46fa-9afa-eb9d937713c3 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
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 |