doxylamine succinate and pyridoxine hydrochloride

Generic: doxylamine succinate and pyridoxine hydrochloride

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxylamine succinate and pyridoxine hydrochloride
Generic Name doxylamine succinate and pyridoxine hydrochloride
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

doxylamine succinate 10 mg/1, pyridoxine hydrochloride 10 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-4615
Product ID 0378-4615_948c17d8-e019-4e4e-b93b-a775ec327a6d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207825
Marketing Start 2020-07-21
Marketing End 2026-05-31

Pharmacologic Class

Classes
analogs/derivatives [chemical/ingredient] antihistamine [epc] histamine receptor antagonists [moa] vitamin b 6 [chemical/ingredient] vitamin b6 analog [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03784615
Hyphenated Format 0378-4615

Supplemental Identifiers

RxCUI
1375948
UPC
0303784615010
UNII
V9BI9B5YI2 68Y4CF58BV

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name doxylamine succinate and pyridoxine hydrochloride (source: ndc)
Generic Name doxylamine succinate and pyridoxine hydrochloride (source: ndc)
Application Number ANDA207825 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-4615-01)
source: ndc

Packages (1)

0378-4615-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-4615-01)

Ingredients (2)

doxylamine succinate (10 mg/1) pyridoxine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Doxylamine Succinate and Pyridoxine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "948c17d8-e019-4e4e-b93b-a775ec327a6d", "openfda": {"upc": ["0303784615010"], "unii": ["V9BI9B5YI2", "68Y4CF58BV"], "rxcui": ["1375948"], "spl_set_id": ["957865a2-efcf-43a6-92a8-f9f980892833"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-4615-01)", "package_ndc": "0378-4615-01", "marketing_end_date": "20260531", "marketing_start_date": "20200721"}], "brand_name": "Doxylamine Succinate and Pyridoxine Hydrochloride", "product_id": "0378-4615_948c17d8-e019-4e4e-b93b-a775ec327a6d", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Analogs/Derivatives [Chemical/Ingredient]", "Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]", "Vitamin B 6 [Chemical/Ingredient]", "Vitamin B6 Analog [EPC]"], "product_ndc": "0378-4615", "generic_name": "doxylamine succinate and pyridoxine hydrochloride", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxylamine Succinate and Pyridoxine Hydrochloride", "active_ingredients": [{"name": "DOXYLAMINE SUCCINATE", "strength": "10 mg/1"}, {"name": "PYRIDOXINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA207825", "marketing_category": "ANDA", "marketing_end_date": "20260531", "marketing_start_date": "20200721"}