habitrol nicotine polacrilex 2 mg coated cinnamon

Generic: nicotine polacrilex

Labeler: dr. reddy's laboratories inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name habitrol nicotine polacrilex 2 mg coated cinnamon
Generic Name nicotine polacrilex
Labeler dr. reddy's laboratories inc.
Dosage Form GUM, CHEWING
Routes
ORAL
Active Ingredients

nicotine 2 mg/1

Manufacturer
Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 55741-004
Product ID 55741-004_7e00f967-584e-45d0-8d0e-759fe85ff0b4
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079216
Listing Expiration 2026-12-31
Marketing Start 2025-07-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55741004
Hyphenated Format 55741-004

Supplemental Identifiers

RxCUI
314119 2717557
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 habitrol nicotine polacrilex 2 mg coated cinnamon (source: ndc)
Generic Name nicotine polacrilex (source: ndc)
Application Number ANDA079216 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 10 GUM, CHEWING in 1 BLISTER PACK (55741-004-10)
  • 15 BLISTER PACK in 1 CARTON (55741-004-15) / 10 GUM, CHEWING in 1 BLISTER PACK
  • 8 BLISTER PACK in 1 CARTON (55741-004-80) / 10 GUM, CHEWING in 1 BLISTER PACK
source: ndc

Packages (3)

Ingredients (1)

nicotine (2 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "7e00f967-584e-45d0-8d0e-759fe85ff0b4", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["314119", "2717557"], "spl_set_id": ["6874a9f1-d180-4073-8226-df6e21bcf0b7"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 GUM, CHEWING in 1 BLISTER PACK (55741-004-10)", "package_ndc": "55741-004-10", "marketing_start_date": "20250728"}, {"sample": false, "description": "15 BLISTER PACK in 1 CARTON (55741-004-15)  / 10 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "55741-004-15", "marketing_start_date": "20250728"}, {"sample": false, "description": "8 BLISTER PACK in 1 CARTON (55741-004-80)  / 10 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "55741-004-80", "marketing_start_date": "20250728"}], "brand_name": "Habitrol Nicotine Polacrilex 2 mg Coated Cinnamon", "product_id": "55741-004_7e00f967-584e-45d0-8d0e-759fe85ff0b4", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "55741-004", "generic_name": "Nicotine Polacrilex", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Habitrol Nicotine Polacrilex 2 mg Coated Cinnamon", "active_ingredients": [{"name": "NICOTINE", "strength": "2 mg/1"}], "application_number": "ANDA079216", "marketing_category": "ANDA", "marketing_start_date": "20250728", "listing_expiration_date": "20261231"}