habitrol nicotine polacrilex gum 4 mg coated fruit

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 gum 4 mg coated fruit
Generic Name nicotine polacrilex
Labeler dr. reddy's laboratories inc.
Dosage Form GUM, CHEWING
Routes
ORAL
Active Ingredients

nicotine 4 mg/1

Manufacturer
Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 75907-300
Product ID 75907-300_a4527ea5-aaa6-4b69-8420-bcf930ed2090
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079038
Listing Expiration 2026-12-31
Marketing Start 2025-06-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75907300
Hyphenated Format 75907-300

Supplemental Identifiers

RxCUI
311975 2717264
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 gum 4 mg coated fruit (source: ndc)
Generic Name nicotine polacrilex (source: ndc)
Application Number ANDA079038 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 10 GUM, CHEWING in 1 BLISTER PACK (75907-300-10)
  • 15 BLISTER PACK in 1 CARTON (75907-300-15) / 10 GUM, CHEWING in 1 BLISTER PACK
  • 8 BLISTER PACK in 1 CARTON (75907-300-80) / 10 GUM, CHEWING in 1 BLISTER PACK
source: ndc

Packages (3)

75907-300-10 10 GUM, CHEWING in 1 BLISTER PACK (75907-300-10) 75907-300-15 15 BLISTER PACK in 1 CARTON (75907-300-15) / 10 GUM, CHEWING in 1 BLISTER PACK 75907-300-80 8 BLISTER PACK in 1 CARTON (75907-300-80) / 10 GUM, CHEWING in 1 BLISTER PACK

Ingredients (1)

nicotine (4 mg/1)

Linked Drug Pages (1)

Habitrol Nicotine Polacrilex Gum 4 mg Coated Fruit ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a4527ea5-aaa6-4b69-8420-bcf930ed2090", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["311975", "2717264"], "spl_set_id": ["5d3b45d6-97c2-4400-ad09-95a4b21f5324"], "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 (75907-300-10)", "package_ndc": "75907-300-10", "marketing_start_date": "20250612"}, {"sample": false, "description": "15 BLISTER PACK in 1 CARTON (75907-300-15)  / 10 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "75907-300-15", "marketing_start_date": "20250612"}, {"sample": false, "description": "8 BLISTER PACK in 1 CARTON (75907-300-80)  / 10 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "75907-300-80", "marketing_start_date": "20250612"}], "brand_name": "Habitrol Nicotine Polacrilex Gum 4 mg Coated Fruit", "product_id": "75907-300_a4527ea5-aaa6-4b69-8420-bcf930ed2090", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "75907-300", "generic_name": "Nicotine Polacrilex", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Habitrol Nicotine Polacrilex Gum 4 mg Coated Fruit", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA079038", "marketing_category": "ANDA", "marketing_start_date": "20250612", "listing_expiration_date": "20261231"}