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 |