berkley and jensen nicotine

Generic: nicotine polacrilex

Labeler: bjwc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name berkley and jensen nicotine
Generic Name nicotine polacrilex
Labeler bjwc
Dosage Form LOZENGE
Routes
ORAL
Active Ingredients

nicotine 2 mg/1

Manufacturer
BJWC

Identifiers & Regulatory

Product NDC 68391-734
Product ID 68391-734_1055f032-3a6e-40d3-8343-d144953c143d
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA203690
Listing Expiration 2026-12-31
Marketing Start 2017-11-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68391734
Hyphenated Format 68391-734

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 berkley and jensen nicotine (source: ndc)
Generic Name nicotine polacrilex (source: ndc)
Application Number ANDA203690 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 27 LOZENGE in 1 BOTTLE (68391-734-01)
  • 7 BOTTLE in 1 PACKAGE (68391-734-06) / 27 LOZENGE in 1 BOTTLE
source: ndc

Packages (2)

68391-734-01 27 LOZENGE in 1 BOTTLE (68391-734-01) 68391-734-06 7 BOTTLE in 1 PACKAGE (68391-734-06) / 27 LOZENGE in 1 BOTTLE

Ingredients (1)

nicotine (2 mg/1)

Linked Drug Pages (1)

berkley and jensen nicotine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1055f032-3a6e-40d3-8343-d144953c143d", "openfda": {"nui": ["N0000175706", "M0014836"], "upc": ["0012345678905"], "unii": ["6M3C89ZY6R"], "rxcui": ["359817"], "spl_set_id": ["1055f032-3a6e-40d3-8343-d144953c143d"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["BJWC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "27 LOZENGE in 1 BOTTLE (68391-734-01)", "package_ndc": "68391-734-01", "marketing_start_date": "20171106"}, {"sample": false, "description": "7 BOTTLE in 1 PACKAGE (68391-734-06)  / 27 LOZENGE in 1 BOTTLE", "package_ndc": "68391-734-06", "marketing_start_date": "20171106"}], "brand_name": "berkley and jensen nicotine", "product_id": "68391-734_1055f032-3a6e-40d3-8343-d144953c143d", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "68391-734", "generic_name": "Nicotine Polacrilex", "labeler_name": "BJWC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "berkley and jensen nicotine", "active_ingredients": [{"name": "NICOTINE", "strength": "2 mg/1"}], "application_number": "ANDA203690", "marketing_category": "ANDA", "marketing_start_date": "20171106", "listing_expiration_date": "20261231"}