nicotine polacrilex

Generic: nicotine polacrilex

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

Drug Facts

Product Profile

Brand Name nicotine polacrilex
Generic Name nicotine polacrilex
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 43598-487
Product ID 43598-487_33e2c1b3-2ea4-98f4-47c2-320c8ddd608e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA212796
Listing Expiration 2026-12-31
Marketing Start 2020-06-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598487
Hyphenated Format 43598-487

Supplemental Identifiers

RxCUI
359817 359818
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 nicotine polacrilex (source: ndc)
Generic Name nicotine polacrilex (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 (43598-487-12) / 24 LOZENGE in 1 BOTTLE
  • 5 BOTTLE in 1 CARTON (43598-487-13) / 27 LOZENGE in 1 BOTTLE
  • 6 BOTTLE in 1 CARTON (43598-487-14) / 24 LOZENGE in 1 BOTTLE
  • 6 BOTTLE in 1 CARTON (43598-487-16) / 27 LOZENGE in 1 BOTTLE
  • 7 BOTTLE in 1 CARTON (43598-487-17) / 24 LOZENGE in 1 BOTTLE
  • 7 BOTTLE in 1 CARTON (43598-487-18) / 27 LOZENGE in 1 BOTTLE
  • 8 BOTTLE in 1 CARTON (43598-487-19) / 24 LOZENGE in 1 BOTTLE
  • 10 BOTTLE in 1 CARTON (43598-487-22) / 24 LOZENGE in 1 BOTTLE
  • 8 BOTTLE in 1 CARTON (43598-487-23) / 27 LOZENGE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (43598-487-24) / 24 LOZENGE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (43598-487-27) / 27 LOZENGE in 1 BOTTLE
  • 10 BOTTLE in 1 CARTON (43598-487-29) / 27 LOZENGE in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (43598-487-48) / 24 LOZENGE in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (43598-487-54) / 27 LOZENGE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (43598-487-72) / 24 LOZENGE in 1 BOTTLE
  • 7 BOTTLE in 1 CARTON (43598-487-73) / 24 LOZENGE in 1 BOTTLE
  • 7 BOTTLE in 1 CARTON (43598-487-74) / 27 LOZENGE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (43598-487-81) / 27 LOZENGE in 1 BOTTLE
  • 4 BOTTLE in 1 CARTON (43598-487-96) / 24 LOZENGE in 1 BOTTLE
source: ndc

Packages (19)

43598-487-12 5 BOTTLE in 1 CARTON (43598-487-12) / 24 LOZENGE in 1 BOTTLE 43598-487-13 5 BOTTLE in 1 CARTON (43598-487-13) / 27 LOZENGE in 1 BOTTLE 43598-487-14 6 BOTTLE in 1 CARTON (43598-487-14) / 24 LOZENGE in 1 BOTTLE 43598-487-16 6 BOTTLE in 1 CARTON (43598-487-16) / 27 LOZENGE in 1 BOTTLE 43598-487-17 7 BOTTLE in 1 CARTON (43598-487-17) / 24 LOZENGE in 1 BOTTLE 43598-487-18 7 BOTTLE in 1 CARTON (43598-487-18) / 27 LOZENGE in 1 BOTTLE 43598-487-19 8 BOTTLE in 1 CARTON (43598-487-19) / 24 LOZENGE in 1 BOTTLE 43598-487-22 10 BOTTLE in 1 CARTON (43598-487-22) / 24 LOZENGE in 1 BOTTLE 43598-487-23 8 BOTTLE in 1 CARTON (43598-487-23) / 27 LOZENGE in 1 BOTTLE 43598-487-24 1 BOTTLE in 1 CARTON (43598-487-24) / 24 LOZENGE in 1 BOTTLE 43598-487-27 1 BOTTLE in 1 CARTON (43598-487-27) / 27 LOZENGE in 1 BOTTLE 43598-487-29 10 BOTTLE in 1 CARTON (43598-487-29) / 27 LOZENGE in 1 BOTTLE 43598-487-48 2 BOTTLE in 1 CARTON (43598-487-48) / 24 LOZENGE in 1 BOTTLE 43598-487-54 2 BOTTLE in 1 CARTON (43598-487-54) / 27 LOZENGE in 1 BOTTLE 43598-487-72 3 BOTTLE in 1 CARTON (43598-487-72) / 24 LOZENGE in 1 BOTTLE 43598-487-73 7 BOTTLE in 1 CARTON (43598-487-73) / 24 LOZENGE in 1 BOTTLE 43598-487-74 7 BOTTLE in 1 CARTON (43598-487-74) / 27 LOZENGE in 1 BOTTLE 43598-487-81 3 BOTTLE in 1 CARTON (43598-487-81) / 27 LOZENGE in 1 BOTTLE 43598-487-96 4 BOTTLE in 1 CARTON (43598-487-96) / 24 LOZENGE in 1 BOTTLE

Ingredients (1)

nicotine (4 mg/1)

Linked Drug Pages (1)

Nicotine Polacrilex ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "33e2c1b3-2ea4-98f4-47c2-320c8ddd608e", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["359817", "359818"], "spl_set_id": ["b0fdb36d-4cf5-8a91-3da1-90e3587450f9"], "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": "5 BOTTLE in 1 CARTON (43598-487-12)  / 24 LOZENGE in 1 BOTTLE", "package_ndc": "43598-487-12", "marketing_start_date": "20200609"}, {"sample": false, "description": "5 BOTTLE in 1 CARTON (43598-487-13)  / 27 LOZENGE in 1 BOTTLE", "package_ndc": "43598-487-13", "marketing_start_date": "20200609"}, {"sample": false, "description": "6 BOTTLE in 1 CARTON (43598-487-14)  / 24 LOZENGE in 1 BOTTLE", "package_ndc": "43598-487-14", "marketing_start_date": "20200609"}, {"sample": false, "description": "6 BOTTLE in 1 CARTON (43598-487-16)  / 27 LOZENGE in 1 BOTTLE", "package_ndc": "43598-487-16", "marketing_start_date": "20200609"}, {"sample": false, "description": "7 BOTTLE in 1 CARTON (43598-487-17)  / 24 LOZENGE in 1 BOTTLE", "package_ndc": "43598-487-17", "marketing_start_date": "20200609"}, {"sample": false, "description": "7 BOTTLE in 1 CARTON (43598-487-18)  / 27 LOZENGE in 1 BOTTLE", "package_ndc": "43598-487-18", "marketing_start_date": "20200609"}, {"sample": false, "description": "8 BOTTLE in 1 CARTON (43598-487-19)  / 24 LOZENGE in 1 BOTTLE", "package_ndc": "43598-487-19", "marketing_start_date": "20200609"}, {"sample": false, "description": "10 BOTTLE in 1 CARTON (43598-487-22)  / 24 LOZENGE in 1 BOTTLE", "package_ndc": "43598-487-22", "marketing_start_date": "20200609"}, {"sample": false, "description": "8 BOTTLE in 1 CARTON (43598-487-23)  / 27 LOZENGE in 1 BOTTLE", "package_ndc": "43598-487-23", "marketing_start_date": "20200609"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (43598-487-24)  / 24 LOZENGE in 1 BOTTLE", "package_ndc": "43598-487-24", "marketing_start_date": "20200609"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (43598-487-27)  / 27 LOZENGE in 1 BOTTLE", "package_ndc": "43598-487-27", "marketing_start_date": "20200609"}, {"sample": false, "description": "10 BOTTLE in 1 CARTON (43598-487-29)  / 27 LOZENGE in 1 BOTTLE", "package_ndc": "43598-487-29", "marketing_start_date": "20200609"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (43598-487-48)  / 24 LOZENGE in 1 BOTTLE", "package_ndc": "43598-487-48", "marketing_start_date": "20200609"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (43598-487-54)  / 27 LOZENGE in 1 BOTTLE", "package_ndc": "43598-487-54", "marketing_start_date": "20200609"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (43598-487-72)  / 24 LOZENGE in 1 BOTTLE", "package_ndc": "43598-487-72", "marketing_start_date": "20200609"}, {"sample": false, "description": "7 BOTTLE in 1 CARTON (43598-487-73)  / 24 LOZENGE in 1 BOTTLE", "package_ndc": "43598-487-73", "marketing_start_date": "20200609"}, {"sample": false, "description": "7 BOTTLE in 1 CARTON (43598-487-74)  / 27 LOZENGE in 1 BOTTLE", "package_ndc": "43598-487-74", "marketing_start_date": "20200609"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (43598-487-81)  / 27 LOZENGE in 1 BOTTLE", "package_ndc": "43598-487-81", "marketing_start_date": "20200609"}, {"sample": false, "description": "4 BOTTLE in 1 CARTON (43598-487-96)  / 24 LOZENGE in 1 BOTTLE", "package_ndc": "43598-487-96", "marketing_start_date": "20200609"}], "brand_name": "Nicotine Polacrilex", "product_id": "43598-487_33e2c1b3-2ea4-98f4-47c2-320c8ddd608e", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "43598-487", "generic_name": "Nicotine Polacrilex", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine Polacrilex", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA212796", "marketing_category": "ANDA", "marketing_start_date": "20200609", "listing_expiration_date": "20261231"}