Guaifenesin and Dextromethorphan HBr is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Aurohealth Llc. The primary component is Guaifenesin; Dextromethorphan Hydrobromide.
| Product ID | 58602-715_2d67d36e-a36e-47c0-82e4-3da750caf04d |
| NDC | 58602-715 |
| Product Type | Human Otc Drug |
| Proprietary Name | Guaifenesin and Dextromethorphan HBr |
| Generic Name | Guaifenesin And Dextromethorphan Hbr |
| Dosage Form | Tablet, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-03-17 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA206941 |
| Labeler Name | Aurohealth LLC |
| Substance Name | GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE |
| Active Ingredient Strength | 1200 mg/1; mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2017-03-17 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA206941 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-03-17 |
| Marketing Category | ANDA |
| Application Number | ANDA206941 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-03-17 |
| Marketing Category | ANDA |
| Application Number | ANDA206941 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-03-17 |
| Marketing Category | ANDA |
| Application Number | ANDA206941 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-03-17 |
| Marketing Category | ANDA |
| Application Number | ANDA206941 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-03-17 |
| Marketing Category | ANDA |
| Application Number | ANDA206941 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-03-17 |
| Marketing Category | ANDA |
| Application Number | ANDA206941 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-03-17 |
| Marketing Category | ANDA |
| Application Number | ANDA206941 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-03-17 |
| Marketing Category | ANDA |
| Application Number | ANDA206941 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-03-17 |
| Marketing Category | ANDA |
| Application Number | ANDA206941 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-03-17 |
| Marketing Category | ANDA |
| Application Number | ANDA206941 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-03-17 |
| Marketing Category | ANDA |
| Application Number | ANDA206941 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-03-17 |
| Ingredient | Strength |
|---|---|
| GUAIFENESIN | 1200 mg/1 |
| SPL SET ID: | d0b0ceb8-ef42-4baa-85b3-4d7d2e6f66b7 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |