nighttime sleep aid

Generic: nighttime sleep aid

Labeler: allegiant health
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nighttime sleep aid
Generic Name nighttime sleep aid
Labeler allegiant health
Dosage Form TABLET
Routes
ORAL
Active Ingredients

doxylamine succinate 25 mg/1

Manufacturer
Allegiant Health

Identifiers & Regulatory

Product NDC 69168-439
Product ID 69168-439_8accb0e9-d994-4b6a-acc3-4b416f3f65ba
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA040564
Listing Expiration 2026-12-31
Marketing Start 2023-05-16

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69168439
Hyphenated Format 69168-439

Supplemental Identifiers

RxCUI
1101446
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 nighttime sleep aid (source: ndc)
Generic Name nighttime sleep aid (source: ndc)
Application Number ANDA040564 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 120 TABLET in 1 BOTTLE (69168-439-06)
  • 40 TABLET in 1 BOTTLE (69168-439-40)
  • 2 BLISTER PACK in 1 CARTON (69168-439-84) / 8 TABLET in 1 BLISTER PACK
  • 200 TABLET in 1 BOTTLE (69168-439-98)
source: ndc

Packages (4)

69168-439-06 120 TABLET in 1 BOTTLE (69168-439-06) 69168-439-40 40 TABLET in 1 BOTTLE (69168-439-40) 69168-439-84 2 BLISTER PACK in 1 CARTON (69168-439-84) / 8 TABLET in 1 BLISTER PACK 69168-439-98 200 TABLET in 1 BOTTLE (69168-439-98)

Ingredients (1)

doxylamine succinate (25 mg/1)

Linked Drug Pages (1)

Nighttime Sleep Aid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8accb0e9-d994-4b6a-acc3-4b416f3f65ba", "openfda": {"unii": ["V9BI9B5YI2"], "rxcui": ["1101446"], "spl_set_id": ["3761182c-275b-40f3-a262-9ef5f5a80723"], "manufacturer_name": ["Allegiant Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE (69168-439-06)", "package_ndc": "69168-439-06", "marketing_start_date": "20230516"}, {"sample": false, "description": "40 TABLET in 1 BOTTLE (69168-439-40)", "package_ndc": "69168-439-40", "marketing_start_date": "20231106"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (69168-439-84)  / 8 TABLET in 1 BLISTER PACK", "package_ndc": "69168-439-84", "marketing_start_date": "20230516"}, {"sample": false, "description": "200 TABLET in 1 BOTTLE (69168-439-98)", "package_ndc": "69168-439-98", "marketing_start_date": "20231106"}], "brand_name": "Nighttime Sleep Aid", "product_id": "69168-439_8accb0e9-d994-4b6a-acc3-4b416f3f65ba", "dosage_form": "TABLET", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "69168-439", "generic_name": "Nighttime Sleep Aid", "labeler_name": "Allegiant Health", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nighttime Sleep Aid", "active_ingredients": [{"name": "DOXYLAMINE SUCCINATE", "strength": "25 mg/1"}], "application_number": "ANDA040564", "marketing_category": "ANDA", "marketing_start_date": "20230516", "listing_expiration_date": "20261231"}