Presgen is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Kramer Novis. The primary component is Guaifenesin; Phenylephrine Hydrochloride; Dextromethorphan Hydrobromide.
| Product ID | 52083-632_80efc77a-89a1-4630-9db4-6055cede83b8 |
| NDC | 52083-632 |
| Product Type | Human Otc Drug |
| Proprietary Name | Presgen |
| Generic Name | Guaifenesin, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide |
| Dosage Form | Syrup |
| Route of Administration | ORAL |
| Marketing Start Date | 2011-03-28 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Labeler Name | Kramer Novis |
| Substance Name | GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE |
| Active Ingredient Strength | 200 mg/5mL; mg/5mL; mg/5mL |
| NDC Exclude Flag | E |
| Listing Certified Through | 2018-12-31 |
| Marketing Start Date | 2011-03-28 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2011-03-28 |
| Ingredient | Strength |
|---|---|
| GUAIFENESIN | 200 mg/5mL |
| SPL SET ID: | edad7a86-0d27-4a98-85b2-4b6725904f28 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 52083-632 | Presgen | guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide |
| 69140-620 | Klernaz | Guaifenesin, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide |
| 52083-231 | Tussi Pres | guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide |
| 52083-233 | Tussi Pres | guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide |