berkley and jensen nicotine polacrilex

Generic: nicotine polacrilex

Labeler: bjwc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

nicotine 4 mg/1

Manufacturer
BJWC

Identifiers & Regulatory

Product NDC 68391-873
Product ID 68391-873_1b1ebcd0-e7ac-4c86-a922-fd02744b427e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077007
Listing Expiration 2026-12-31
Marketing Start 2006-05-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68391873
Hyphenated Format 68391-873

Supplemental Identifiers

RxCUI
359818
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 polacrilex (source: ndc)
Generic Name nicotine polacrilex (source: ndc)
Application Number ANDA077007 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 7 CONTAINER in 1 CARTON (68391-873-13) / 27 LOZENGE in 1 CONTAINER
source: ndc

Packages (1)

68391-873-13 7 CONTAINER in 1 CARTON (68391-873-13) / 27 LOZENGE in 1 CONTAINER

Ingredients (1)

nicotine (4 mg/1)

Linked Drug Pages (1)

berkley and jensen nicotine polacrilex ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1b1ebcd0-e7ac-4c86-a922-fd02744b427e", "openfda": {"nui": ["N0000175706", "M0014836"], "upc": ["0012345678905"], "unii": ["6M3C89ZY6R"], "rxcui": ["359818"], "spl_set_id": ["b586ce1c-77cd-497c-b22c-8c97f54583ba"], "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": "7 CONTAINER in 1 CARTON (68391-873-13)  / 27 LOZENGE in 1 CONTAINER", "package_ndc": "68391-873-13", "marketing_start_date": "20161123"}], "brand_name": "berkley and jensen nicotine polacrilex", "product_id": "68391-873_1b1ebcd0-e7ac-4c86-a922-fd02744b427e", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "68391-873", "generic_name": "Nicotine Polacrilex", "labeler_name": "BJWC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "berkley and jensen nicotine polacrilex", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA077007", "marketing_category": "ANDA", "marketing_start_date": "20060502", "listing_expiration_date": "20261231"}