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NDC 55494-0120-99 BONJESTA 20; 20 mg/1; mg/1 Details
BONJESTA 20; 20 mg/1; mg/1
BONJESTA is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Duchesnay USA, Inc.. The primary component is DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE.
Product Information
| NDC | 55494-0120 |
|---|---|
| Product ID | 55494-120_af3a70f8-e0ea-4863-a89b-55e3ebe481f3 |
| Associated GPIs | 50309902100430 |
| GCN Sequence Number | 076841 |
| GCN Sequence Number Description | doxylamine succinate/vit B6 TAB IR DR 20 MG-20MG ORAL |
| HIC3 | H6J |
| HIC3 Description | ANTIEMETIC/ANTIVERTIGO AGENTS |
| GCN | 42645 |
| HICL Sequence Number | 001970 |
| HICL Sequence Number Description | DOXYLAMINE SUCCINATE/PYRIDOXINE HCL (VITAMIN B6) |
| Brand/Generic | Brand |
| Proprietary Name | BONJESTA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | doxylamine succinate and pyridoxine hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 20; 20 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE |
| Labeler Name | Duchesnay USA, Inc. |
| Pharmaceutical Class | Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA209661 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 55494-0120-99 (55494012099)
| NDC Package Code | 55494-120-99 |
|---|---|
| Billing NDC | 55494012099 |
| Package | 6 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-99) |
| Marketing Start Date | 2018-02-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |