members mark nicotine (68196-084)

Drug Facts

Product Profile

Brand Name members mark nicotine

Generic Name nicotine polacrilex

Labeler sam's west inc

Dosage Form LOZENGE

Routes

ORAL

Active Ingredients

nicotine 4 mg/1

Manufacturer

Sam's West Inc

Identifiers & Regulatory

Product NDC 68196-084

Product ID 68196-084_a0f96342-bb41-486f-8266-8cdcf2c2225a

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA203690

Listing Expiration 2026-12-31

Marketing Start 2020-08-05

Pharmacologic Class

Established (EPC)

cholinergic nicotinic agonist [epc]

Chemical Structure

nicotine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68196084

Hyphenated Format 68196-084

Supplemental Identifiers

RxCUI

359818

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 members mark nicotine (source: ndc)

Generic Name nicotine polacrilex (source: ndc)

Application Number ANDA203690 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

4 mg/1

source: ndc

Packaging

8 CONTAINER in 1 CARTON (68196-084-08) / 27 LOZENGE in 1 CONTAINER (68196-084-09)

source: ndc

Packages (1)

68196-084-08 8 CONTAINER in 1 CARTON (68196-084-08) / 27 LOZENGE in 1 CONTAINER (68196-084-09)

Ingredients (1)

nicotine (4 mg/1)

Linked Drug Pages (1)

members mark nicotine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "a0f96342-bb41-486f-8266-8cdcf2c2225a", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["359818"], "spl_set_id": ["d185b5e7-9bb1-4d16-b146-1fbfba874053"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Sam's West Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 CONTAINER in 1 CARTON (68196-084-08)  / 27 LOZENGE in 1 CONTAINER (68196-084-09)", "package_ndc": "68196-084-08", "marketing_start_date": "20200805"}], "brand_name": "members mark nicotine", "product_id": "68196-084_a0f96342-bb41-486f-8266-8cdcf2c2225a", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "68196-084", "generic_name": "Nicotine Polacrilex", "labeler_name": "Sam's West Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "members mark nicotine", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA203690", "marketing_category": "ANDA", "marketing_start_date": "20200805", "listing_expiration_date": "20261231"}