unisom sleeptabs

Generic: doxylamine succinate

Labeler: chattem, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name unisom sleeptabs
Generic Name doxylamine succinate
Labeler chattem, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

doxylamine succinate 25 mg/1

Manufacturer
Chattem, Inc.

Identifiers & Regulatory

Product NDC 41167-0063
Product ID 41167-0063_32b4f344-3f75-4804-b8cb-800fe2b508c0
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA040167
Listing Expiration 2027-12-31
Marketing Start 2016-01-15

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 411670063
Hyphenated Format 41167-0063

Supplemental Identifiers

RxCUI
1101446 1101448
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 unisom sleeptabs (source: ndc)
Generic Name doxylamine succinate (source: ndc)
Application Number ANDA040167 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (41167-0063-5) / 16 TABLET in 1 BLISTER PACK
  • 1 BOTTLE, PLASTIC in 1 CARTON (41167-0063-6) / 32 TABLET in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (41167-0063-7) / 48 TABLET in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (41167-0063-8) / 80 TABLET in 1 BOTTLE, PLASTIC
source: ndc

Packages (4)

41167-0063-5 1 BLISTER PACK in 1 CARTON (41167-0063-5) / 16 TABLET in 1 BLISTER PACK 41167-0063-6 1 BOTTLE, PLASTIC in 1 CARTON (41167-0063-6) / 32 TABLET in 1 BOTTLE, PLASTIC 41167-0063-7 1 BOTTLE, PLASTIC in 1 CARTON (41167-0063-7) / 48 TABLET in 1 BOTTLE, PLASTIC 41167-0063-8 1 BOTTLE, PLASTIC in 1 CARTON (41167-0063-8) / 80 TABLET in 1 BOTTLE, PLASTIC

Ingredients (1)

doxylamine succinate (25 mg/1)

Linked Drug Pages (1)

Unisom SleepTabs ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "32b4f344-3f75-4804-b8cb-800fe2b508c0", "openfda": {"unii": ["V9BI9B5YI2"], "rxcui": ["1101446", "1101448"], "spl_set_id": ["f591d52f-5610-4517-a96f-1ed63deb00bc"], "manufacturer_name": ["Chattem, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (41167-0063-5)  / 16 TABLET in 1 BLISTER PACK", "package_ndc": "41167-0063-5", "marketing_start_date": "20160115"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (41167-0063-6)  / 32 TABLET in 1 BOTTLE, PLASTIC", "package_ndc": "41167-0063-6", "marketing_start_date": "20160115"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (41167-0063-7)  / 48 TABLET in 1 BOTTLE, PLASTIC", "package_ndc": "41167-0063-7", "marketing_start_date": "20160115"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (41167-0063-8)  / 80 TABLET in 1 BOTTLE, PLASTIC", "package_ndc": "41167-0063-8", "marketing_start_date": "20160115"}], "brand_name": "Unisom SleepTabs", "product_id": "41167-0063_32b4f344-3f75-4804-b8cb-800fe2b508c0", "dosage_form": "TABLET", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "41167-0063", "generic_name": "Doxylamine Succinate", "labeler_name": "Chattem, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Unisom SleepTabs", "active_ingredients": [{"name": "DOXYLAMINE SUCCINATE", "strength": "25 mg/1"}], "application_number": "ANDA040167", "marketing_category": "ANDA", "marketing_start_date": "20160115", "listing_expiration_date": "20271231"}