What is NDC 0009-5401?

0009-5401 is the product NDC for Nicotrol (nicotine), Nicotine 10 mg/mL spray, metered, listed with the FDA by Pharmacia & Upjohn Company LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Pharmacia & Upjohn Company LLC, NDC labeler code 0009. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Nicotrol?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nicotrol NDC 0009-5401 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0009-5401Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00009-5401Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0009-5401-01	0000954010100009540101	4 BOTTLE, SPRAY in 1 BOX (0009-5401-01) / 10 mL in 1 BOTTLE, SPRAYMarketed from May 22, 1996

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Nicotrol
Generic name (nonproprietary): nicotine
Active ingredients: Nicotine — 10 mg/mL
Dosage form: Spray, Metered
Route: Nasal
Labeler: Pharmacia & Upjohn Company LLCNDC labeler code 0009
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020385
Marketing start: May 22, 1996
Listing expires: Dec 31, 2026
Other FDA classes: Nicotine (Chemical structure)
Identifiers: Product ID 0009-5401_33997044-c41d-481b-b724-15463f892bd1SPL ID 33997044-c41d-481b-b724-15463f892bd1SPL set ID acb7d02d-249b-4645-ac1b-8ff9a56dd244RxCUI 1797886, 1797888UNII 6M3C89ZY6R
Pharmacologic class: Cholinergic Nicotinic Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400009540101 followed by a unit qualifier and the quantity

Package 00009-5401-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective May 29, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE NICOTROL NS is indicated as an aid to smoking cessation for the relief of nicotine withdrawal symptoms. NICOTROL NS therapy should be used as a part of a comprehensive behavioral smoking cessation program. The safety and efficacy of the continued use of NICOTROL NS for periods longer than 6 months have not been adequately studied and such use is not recommended.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0009-5401

What is NDC 0009-5401?: 0009-5401 is the product NDC for Nicotrol (nicotine), Nicotine 10 mg/mL spray, metered, listed with the FDA by Pharmacia & Upjohn Company LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nicotrol (Nicotine).
What is the active ingredient?: Nicotine.
Who is the labeler?: Pharmacia & Upjohn Company LLC, NDC labeler code 0009. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nicotrol?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Nicotrol (Nicotine) NDC 0009-5401