NDC 0009-5401

Nicotrol

Nicotine

Nicotrol is a Nasal Spray, Metered in the Human Prescription Drug category. It is labeled and distributed by Pharmacia And Upjohn Company Llc. The primary component is Nicotine.

• Product ID: 0009-5401_580a67d1-210b-4b5b-9de6-61ecd99916f8
• NDC: 0009-5401
• Product Type: Human Prescription Drug
• Proprietary Name: Nicotrol
• Generic Name: Nicotine
• Dosage Form: Spray, Metered
• Route of Administration: NASAL
• Marketing Start Date: 1996-05-22
• Marketing Category: NDA / NDA
• Application Number: NDA020385
• Labeler Name: Pharmacia and Upjohn Company LLC
• Substance Name: NICOTINE
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: Cholinergic Nicotinic Agonist [EPC],Nicotine [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0009-5401-01

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

• Marketing Start Date: 1996-05-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0009-5401-01 [00009540101]

Nicotrol SPRAY, METERED

• Marketing Category: NDA
• Application Number: NDA020385
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1996-05-22

Drug Details

Active Ingredients

Ingredient	Strength
NICOTINE	10 mg/mL

OpenFDA Data

• SPL SET ID: acb7d02d-249b-4645-ac1b-8ff9a56dd244
• Manufacturer:
  • Pharmacia and Upjohn Company LLC
• UNII:
  • 6M3C89ZY6R
• RxNorm Concept Unique ID - RxCUI:
  • 1797886
  • 1797888

Pharmacological Class

• Cholinergic Nicotinic Agonist [EPC]
• Nicotine [CS]

NDC Crossover Matching brand name "Nicotrol" or generic name "Nicotine"

NDC	Brand Name	Generic Name
0009-5400	Nicotrol	nicotine
0009-5401	Nicotrol	nicotine
0067-6011	Meijer NICOTINE TRANSDERMAL SYSTEM	NICOTINE
0067-6012	Meijer NICOTINE TRANSDERMAL SYSTEM	NICOTINE
0067-6013	Meijer NICOTINE TRANSDERMAL SYSTEM	NICOTINE
0135-0194	NICODERM	nicotine
0135-0195	NICODERM	nicotine
0135-0196	NICODERM	nicotine
0363-0451	Nicotine	Nicotine
0363-0455	Nicotine	Nicotine
0363-0457	Nicotine	Nicotine
0536-1106	NICOTINE	NICOTINE
0536-1107	NICOTINE	NICOTINE
0536-1108	NICOTINE	NICOTINE
0536-5894	Nicotine	Nicotine
0536-5895	Nicotine	Nicotine
0536-5896	Nicotine	Nicotine
11673-194	NICOTINE	nicotine
0220-3657	Nicotinum	NICOTINE