nicotine lozenge

Generic: nicotine polacrilex

Labeler: h e b
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicotine lozenge
Generic Name nicotine polacrilex
Labeler h e b
Dosage Form LOZENGE
Routes
ORAL
Active Ingredients

nicotine 2 mg/1

Manufacturer
H E B

Identifiers & Regulatory

Product NDC 37808-674
Product ID 37808-674_f186f7fc-7b7a-4029-a404-99e5f2e1f557
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077007
Listing Expiration 2027-12-31
Marketing Start 2019-04-16

Pharmacologic Class

Established (EPC)
cholinergic nicotinic agonist [epc]
Chemical Structure
nicotine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 37808674
Hyphenated Format 37808-674

Supplemental Identifiers

RxCUI
359817
UPC
0012345678905
UNII
6M3C89ZY6R
NUI
N0000175706 M0014836

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 nicotine lozenge (source: ndc)
Generic Name nicotine polacrilex (source: ndc)
Application Number ANDA077007 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 1 CONTAINER in 1 CARTON (37808-674-03) / 24 LOZENGE in 1 CONTAINER
  • 4 CONTAINER in 1 CARTON (37808-674-10) / 27 LOZENGE in 1 CONTAINER
source: ndc

Packages (2)

37808-674-03 1 CONTAINER in 1 CARTON (37808-674-03) / 24 LOZENGE in 1 CONTAINER 37808-674-10 4 CONTAINER in 1 CARTON (37808-674-10) / 27 LOZENGE in 1 CONTAINER

Ingredients (1)

nicotine (2 mg/1)

Linked Drug Pages (1)

nicotine lozenge ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f186f7fc-7b7a-4029-a404-99e5f2e1f557", "openfda": {"nui": ["N0000175706", "M0014836"], "upc": ["0012345678905"], "unii": ["6M3C89ZY6R"], "rxcui": ["359817"], "spl_set_id": ["db78d030-7abf-494f-94ca-4a385f519faf"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["H E B"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CONTAINER in 1 CARTON (37808-674-03)  / 24 LOZENGE in 1 CONTAINER", "package_ndc": "37808-674-03", "marketing_start_date": "20190416"}, {"sample": false, "description": "4 CONTAINER in 1 CARTON (37808-674-10)  / 27 LOZENGE in 1 CONTAINER", "package_ndc": "37808-674-10", "marketing_start_date": "20190416"}], "brand_name": "nicotine lozenge", "product_id": "37808-674_f186f7fc-7b7a-4029-a404-99e5f2e1f557", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "37808-674", "generic_name": "nicotine polacrilex", "labeler_name": "H E B", "product_type": "HUMAN OTC DRUG", "brand_name_base": "nicotine lozenge", "active_ingredients": [{"name": "NICOTINE", "strength": "2 mg/1"}], "application_number": "ANDA077007", "marketing_category": "ANDA", "marketing_start_date": "20190416", "listing_expiration_date": "20271231"}