Dextromethorphan Polistirex Extended-Release is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Dextromethorphan Hydrobromide.
| Product ID | 65162-700_20542a3d-7028-49a5-973f-4d49645dc526 |
| NDC | 65162-700 |
| Product Type | Human Otc Drug |
| Proprietary Name | Dextromethorphan Polistirex Extended-Release |
| Generic Name | Dextromethorphan Polistirex |
| Dosage Form | Suspension |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-08-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA203133 |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE |
| Active Ingredient Strength | 30 mg/5mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2017-08-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA203133 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-08-01 |
| Marketing Category | ANDA |
| Application Number | ANDA203133 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-08-01 |
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/5mL |
| SPL SET ID: | ce7402d1-e48f-4bf1-90e9-cc57a52b35e5 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 65162-799 | Dextromethorphan Polistirex Extended-Release | Dextromethorphan Polistirex Extended-Release |
| 65162-700 | Dextromethorphan Polistirex Extended-Release | Dextromethorphan Polistirex Extended-Release |
| 0113-7384 | basic care cough DM | dextromethorphan polistirex |
| 0363-0899 | childrens cough dm | Dextromethorphan polistirex |
| 0031-8725 | Childrens Robitussin 12 Hour Cough Relief | dextromethorphan polistirex |
| 0031-8726 | Childrens Robitussin 12 Hour Cough Relief | dextromethorphan polistirex |
| 0363-0384 | Cough DM | dextromethorphan polistirex |
| 0363-0494 | Cough DM | dextromethorphan polistirex |
| 0363-0958 | Cough DM | dextromethorphan polistirex |
| 0904-6312 | cough dm | dextromethorphan polistirex |
| 11822-0384 | Cough DM | dextromethorphan polistirex |
| 11822-0494 | Cough DM | dextromethorphan polistirex |
| 0113-0384 | good sense cough dm | dextromethorphan polistirex |
| 0113-0958 | Good Sense Cough DM | dextromethorphan polistirex |
| 0031-8655 | Robitussin 12 Hour Cough Relief | dextromethorphan polistirex |
| 0031-8753 | Robitussin 12 Hour Cough Relief | dextromethorphan polistirex |
| 0031-8754 | Robitussin 12 Hour Cough Relief | dextromethorphan polistirex |
| 0031-8755 | Robitussin 12 Hour Cough Relief | dextromethorphan polistirex |
| 11673-114 | up and up 12 hour cough relief | dextromethorphan polistirex |