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 GUM, CHEWING
Routes
ORAL
Active Ingredients

nicotine 4 mg/1

Manufacturer
BJWC

Identifiers & Regulatory

Product NDC 68391-309
Product ID 68391-309_ecc73ee8-3d06-4daf-b93b-4d180cc6bc68
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA206393
Listing Expiration 2026-12-31
Marketing Start 2017-02-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68391309
Hyphenated Format 68391-309

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 berkley and jensen nicotine (source: ndc)
Generic Name nicotine polacrilex (source: ndc)
Application Number ANDA206393 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 2 CARTON in 1 CARTON (68391-309-70) / 120 BLISTER PACK in 1 CARTON / 1 GUM, CHEWING in 1 BLISTER PACK
source: ndc

Packages (1)

68391-309-70 2 CARTON in 1 CARTON (68391-309-70) / 120 BLISTER PACK in 1 CARTON / 1 GUM, CHEWING in 1 BLISTER PACK

Ingredients (1)

nicotine (4 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": "ecc73ee8-3d06-4daf-b93b-4d180cc6bc68", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["311975"], "spl_set_id": ["b04f4f1e-55d3-4486-acf1-6a93dc919f2d"], "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": "2 CARTON in 1 CARTON (68391-309-70)  / 120 BLISTER PACK in 1 CARTON / 1 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "68391-309-70", "marketing_start_date": "20201211"}], "brand_name": "Berkley and Jensen Nicotine", "product_id": "68391-309_ecc73ee8-3d06-4daf-b93b-4d180cc6bc68", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "68391-309", "generic_name": "Nicotine Polacrilex", "labeler_name": "BJWC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Berkley and Jensen Nicotine", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA206393", "marketing_category": "ANDA", "marketing_start_date": "20170228", "listing_expiration_date": "20261231"}