members mark nicotine

Generic: nicotine polacrilex

Labeler: sam's west inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name members mark nicotine
Generic Name nicotine polacrilex
Labeler sam's west inc
Dosage Form GUM, CHEWING
Routes
ORAL
Active Ingredients

nicotine 4 mg/1

Manufacturer
Sam's West Inc

Identifiers & Regulatory

Product NDC 68196-170
Product ID 68196-170_d3cb746f-c3df-4620-b26c-02a77f376e10
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076789
Listing Expiration 2026-12-31
Marketing Start 2007-09-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68196170
Hyphenated Format 68196-170

Supplemental Identifiers

RxCUI
311975
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 ANDA076789 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 2 CARTON in 1 PACKAGE (68196-170-01) / 190 BLISTER PACK in 1 CARTON (68196-170-56) / 1 GUM, CHEWING in 1 BLISTER PACK
  • 380 BLISTER PACK in 1 CARTON (68196-170-38) / 1 GUM, CHEWING in 1 BLISTER PACK
source: ndc

Packages (2)

Ingredients (1)

nicotine (4 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "d3cb746f-c3df-4620-b26c-02a77f376e10", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["311975"], "spl_set_id": ["8edad777-6491-4ab2-9835-709bf54d5f0c"], "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": "2 CARTON in 1 PACKAGE (68196-170-01)  / 190 BLISTER PACK in 1 CARTON (68196-170-56)  / 1 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "68196-170-01", "marketing_start_date": "20190418"}, {"sample": false, "description": "380 BLISTER PACK in 1 CARTON (68196-170-38)  / 1 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "68196-170-38", "marketing_start_date": "20250911"}], "brand_name": "members mark nicotine", "product_id": "68196-170_d3cb746f-c3df-4620-b26c-02a77f376e10", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "68196-170", "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": "ANDA076789", "marketing_category": "ANDA", "marketing_start_date": "20070920", "listing_expiration_date": "20261231"}