night time sleep aid

Generic: doxylamine succinate

Labeler: advanced rx llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name night time sleep aid
Generic Name doxylamine succinate
Labeler advanced rx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

doxylamine succinate 25 mg/1

Manufacturer
Advanced Rx LLC

Identifiers & Regulatory

Product NDC 80513-371
Product ID 80513-371_2f0e58dc-121b-d508-e063-6294a90a34ff
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA040564
Listing Expiration 2026-12-31
Marketing Start 2004-08-27

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80513371
Hyphenated Format 80513-371

Supplemental Identifiers

RxCUI
1101446
UPC
0380513000897
UNII
V9BI9B5YI2

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 night time sleep aid (source: ndc)
Generic Name doxylamine succinate (source: ndc)
Application Number ANDA040564 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 225 TABLET in 1 BOTTLE (80513-371-25)
source: ndc

Packages (1)

80513-371-25 225 TABLET in 1 BOTTLE (80513-371-25)

Ingredients (1)

doxylamine succinate (25 mg/1)

Linked Drug Pages (1)

Night Time Sleep Aid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2f0e58dc-121b-d508-e063-6294a90a34ff", "openfda": {"upc": ["0380513000897"], "unii": ["V9BI9B5YI2"], "rxcui": ["1101446"], "spl_set_id": ["db8b730a-1553-4682-96bf-41e670ed0347"], "manufacturer_name": ["Advanced Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "225 TABLET in 1 BOTTLE (80513-371-25)", "package_ndc": "80513-371-25", "marketing_start_date": "20240829"}], "brand_name": "Night Time Sleep Aid", "product_id": "80513-371_2f0e58dc-121b-d508-e063-6294a90a34ff", "dosage_form": "TABLET", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "80513-371", "generic_name": "Doxylamine Succinate", "labeler_name": "Advanced Rx LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Night Time Sleep Aid", "active_ingredients": [{"name": "DOXYLAMINE SUCCINATE", "strength": "25 mg/1"}], "application_number": "ANDA040564", "marketing_category": "ANDA", "marketing_start_date": "20040827", "listing_expiration_date": "20261231"}