nicotrol

Generic: nicotine

Labeler: pharmacia & upjohn company llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicotrol
Generic Name nicotine
Labeler pharmacia & upjohn company llc
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

nicotine 10 mg/mL

Manufacturer
Pharmacia & Upjohn Company LLC

Identifiers & Regulatory

Product NDC 0009-5401
Product ID 0009-5401_33997044-c41d-481b-b724-15463f892bd1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020385
Listing Expiration 2026-12-31
Marketing Start 1996-05-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00095401
Hyphenated Format 0009-5401

Supplemental Identifiers

RxCUI
1797886 1797888
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 nicotrol (source: ndc)
Generic Name nicotine (source: ndc)
Application Number NDA020385 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 4 BOTTLE, SPRAY in 1 BOX (0009-5401-01) / 10 mL in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

0009-5401-01 4 BOTTLE, SPRAY in 1 BOX (0009-5401-01) / 10 mL in 1 BOTTLE, SPRAY

Ingredients (1)

nicotine (10 mg/mL)

Linked Drug Pages (1)

Nicotrol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "33997044-c41d-481b-b724-15463f892bd1", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["1797886", "1797888"], "spl_set_id": ["acb7d02d-249b-4645-ac1b-8ff9a56dd244"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Pharmacia & Upjohn Company LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BOTTLE, SPRAY in 1 BOX (0009-5401-01)  / 10 mL in 1 BOTTLE, SPRAY", "package_ndc": "0009-5401-01", "marketing_start_date": "19960522"}], "brand_name": "Nicotrol", "product_id": "0009-5401_33997044-c41d-481b-b724-15463f892bd1", "dosage_form": "SPRAY, METERED", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "0009-5401", "generic_name": "nicotine", "labeler_name": "Pharmacia & Upjohn Company LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nicotrol", "active_ingredients": [{"name": "NICOTINE", "strength": "10 mg/mL"}], "application_number": "NDA020385", "marketing_category": "NDA", "marketing_start_date": "19960522", "listing_expiration_date": "20261231"}