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NDC 00378-4615-01 Doxylamine Succinate and Pyridoxine Hydrochloride 10; 10 mg/1; mg/1 Details
Doxylamine Succinate and Pyridoxine Hydrochloride 10; 10 mg/1; mg/1
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.
MedlinePlus Drug Summary
The combination of doxylamine and pyridoxine is used to treat nausea and vomiting in pregnant women whose symptoms have not improved after changing their diet or using other non-medicine treatments. Doxylamine is in a class of medications called antihistamines. It works by blocking the action of certain natural substances in the body that may contribute to nausea and vomiting. Pyridoxine (vitamin B6) is a vitamin. It is given because a lack of pyridoxine in the body may also be a factor in causing nausea and vomiting during pregnancy.
Related Packages: 00378-4615-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Doxylamine and Pyridoxine
Product Information
| NDC | 00378-4615 |
|---|---|
| Product ID | 0378-4615_cb6d7357-e5e8-469b-9cc6-24afed78d00b |
| Associated GPIs | 50309902100620 |
| GCN Sequence Number | 004722 |
| GCN Sequence Number Description | doxylamine succinate/vit B6 TABLET DR 10 MG-10MG ORAL |
| HIC3 | H6J |
| HIC3 Description | ANTIEMETIC/ANTIVERTIGO AGENTS |
| GCN | 73860 |
| HICL Sequence Number | 001970 |
| HICL Sequence Number Description | DOXYLAMINE SUCCINATE/PYRIDOXINE HCL (VITAMIN B6) |
| Brand/Generic | Generic |
| Proprietary Name | Doxylamine Succinate and Pyridoxine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | doxylamine succinate and pyridoxine hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, DELAYED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 10; 10 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE |
| Labeler Name | Mylan Pharmaceuticals 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 | ANDA |
| Application Number | ANDA207825 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00378-4615-01 (00378461501)
| NDC Package Code | 0378-4615-01 |
|---|---|
| Billing NDC | 00378461501 |
| Package | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-4615-01) |
| Marketing Start Date | 2020-07-21 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 2.13093 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | DOXYLAMINE-PYRIDOXINE 10-10 MG |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |