Doxylamine Succinate and Pyridoxine Hydrochloride
- Product NDC
- 0378-4615
- 11-digit product format
- 003784615
- Labeler code
- 0378
- Product ID
- 0378-4615_948c17d8-e019-4e4e-b93b-a775ec327a6d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- doxylamine succinate and pyridoxine hydrochloride
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA207825
- Marketing category
- ANDA
- Marketing start
- 2020-07-21
- Marketing end
- 2026-05-31
- Substance
- DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
- Active strength
- 10; 10 mg/1; mg/1
- Pharmacologic classes
- Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-4615-01 | Doxylamine Succinate and Pyridoxine Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-4615 | DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20250119_957865a2-efcf-43a6-92a8-f9f980892833.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-4615-01 | 00378461501 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-4615-01) | 2020-07-21 | 2026-05-31 | No | No | Current |