Doxylamine Succinate and Pyridoxine Hydrochloride is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Doxylamine Succinate; Pyridoxine Hydrochloride.
| Product ID | 0378-4615_0e21f33d-1f0c-45be-b5f7-cc0b8888c511 |
| NDC | 0378-4615 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Doxylamine Succinate and Pyridoxine Hydrochloride |
| Generic Name | Doxylamine Succinate And Pyridoxine Hydrochloride |
| Dosage Form | Tablet, Delayed Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-07-21 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA207825 |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Substance Name | DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE |
| Active Ingredient Strength | 10 mg/1; mg/1 |
| Pharm Classes | Antihistamine [EPC],Histamine Receptor Antagonists [MoA],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2020-07-21 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0378-4615 | Doxylamine Succinate and Pyridoxine Hydrochloride | doxylamine succinate and pyridoxine hydrochloride |
| 0591-2132 | Doxylamine succinate and pyridoxine hydrochloride | Doxylamine succinate and pyridoxine hydrochloride |
| 49884-186 | Doxylamine Succinate and Pyridoxine Hydrochloride | Doxylamine Succinate and Pyridoxine Hydrochloride, Delayed release Tablets 10 mg/10 mg |
| 63629-2184 | Doxylamine Succinate and Pyridoxine Hydrochloride | Doxylamine Succinate and Pyridoxine Hydrochloride, Delayed release Tablets 10 mg/10 mg |
| 63629-8358 | Doxylamine succinate and pyridoxine hydrochloride | Doxylamine succinate and pyridoxine hydrochloride |
| 70505-100 | Doxylamine succinate and pyridoxine hydrochloride | Doxylamine succinate and pyridoxine hydrochloride |
| 55494-120 | BONJESTA | doxylamine succinate and pyridoxine hydrochloride |
| 55494-100 | DICLEGIS | doxylamine succinate and pyridoxine hydrochloride |