| Product NDC: | 55494-100 |
| Proprietary Name: | DICLEGIS |
| Non Proprietary Name: | doxylamine succinate and pyridoxine hydrochloride |
| Active Ingredient(s): | 10; 10 mg/1; mg/1 & nbsp; doxylamine succinate and pyridoxine hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, DELAYED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 55494-100 |
| Labeler Name: | Duchesnay USA, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021876 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20130515 |
| Package NDC: | 55494-100-10 |
| Package Description: | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-10) |
| NDC Code | 55494-100-10 |
| Proprietary Name | DICLEGIS |
| Package Description | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-10) |
| Product NDC | 55494-100 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | doxylamine succinate and pyridoxine hydrochloride |
| Dosage Form Name | TABLET, DELAYED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20130515 |
| Marketing Category Name | NDA |
| Labeler Name | Duchesnay USA, Inc. |
| Substance Name | DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE |
| Strength Number | 10; 10 |
| Strength Unit | mg/1; mg/1 |
| Pharmaceutical Classes |