habitrol nicotine polacrilex lozenge mint

Generic: nicotine polacrilex lozenge 4 mg

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

Drug Facts

Product Profile

Brand Name habitrol nicotine polacrilex lozenge mint
Generic Name nicotine polacrilex lozenge 4 mg
Labeler dr. reddy's laboratories inc.
Dosage Form LOZENGE
Routes
ORAL
Active Ingredients

nicotine 4 mg/1

Manufacturer
Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 43598-987
Product ID 43598-987_f9d24ed4-6477-a9bf-c3e2-ac408911a310
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA212796
Listing Expiration 2026-12-31
Marketing Start 2021-05-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598987
Hyphenated Format 43598-987

Supplemental Identifiers

RxCUI
359817 359818 2548896 2548898
UNII
6M3C89ZY6R
NUI
N0000175706 M0014836

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 lozenge mint (source: ndc)
Generic Name nicotine polacrilex lozenge 4 mg (source: ndc)
Application Number ANDA212796 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 5 BOTTLE in 1 CARTON (43598-987-13) / 27 LOZENGE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (43598-987-24) / 24 LOZENGE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (43598-987-27) / 27 LOZENGE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (43598-987-72) / 24 LOZENGE in 1 BOTTLE
source: ndc

Packages (4)

43598-987-13 5 BOTTLE in 1 CARTON (43598-987-13) / 27 LOZENGE in 1 BOTTLE 43598-987-24 1 BOTTLE in 1 CARTON (43598-987-24) / 24 LOZENGE in 1 BOTTLE 43598-987-27 1 BOTTLE in 1 CARTON (43598-987-27) / 27 LOZENGE in 1 BOTTLE 43598-987-72 3 BOTTLE in 1 CARTON (43598-987-72) / 24 LOZENGE in 1 BOTTLE

Ingredients (1)

nicotine (4 mg/1)

Linked Drug Pages (1)

Habitrol Nicotine Polacrilex Lozenge Mint ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f9d24ed4-6477-a9bf-c3e2-ac408911a310", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["359817", "359818", "2548896", "2548898"], "spl_set_id": ["836bae74-076b-3c92-dee9-22b8519b529d"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "5 BOTTLE in 1 CARTON (43598-987-13)  / 27 LOZENGE in 1 BOTTLE", "package_ndc": "43598-987-13", "marketing_start_date": "20210521"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (43598-987-24)  / 24 LOZENGE in 1 BOTTLE", "package_ndc": "43598-987-24", "marketing_start_date": "20210521"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (43598-987-27)  / 27 LOZENGE in 1 BOTTLE", "package_ndc": "43598-987-27", "marketing_start_date": "20210521"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (43598-987-72)  / 24 LOZENGE in 1 BOTTLE", "package_ndc": "43598-987-72", "marketing_start_date": "20210521"}], "brand_name": "Habitrol Nicotine Polacrilex Lozenge Mint", "product_id": "43598-987_f9d24ed4-6477-a9bf-c3e2-ac408911a310", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "43598-987", "generic_name": "Nicotine Polacrilex Lozenge 4 mg", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Habitrol", "brand_name_suffix": "Nicotine Polacrilex Lozenge Mint", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA212796", "marketing_category": "ANDA", "marketing_start_date": "20210521", "listing_expiration_date": "20261231"}