Nicotine (nicotine polacrilex) NDC 0536-3405

NDC codes

FDA NDC Directory

Product NDC (as listed)0536-3405Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00536-3405Add 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
0536-3405-01	00536340501	100 BLISTER PACK in 1 CARTON (0536-3405-01) / 1 GUM, CHEWING in 1 BLISTER PACK (0536-3405-25)Marketed from Jul 8, 2009

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): Nicotine
Generic name (nonproprietary): nicotine polacrilex
Active ingredients: Nicotine — 4 mg/1
Dosage form: Gum, Chewing
Route: Buccal
Labeler: Rugby Laboratories
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 079219
Marketing start: Jul 8, 2009
Listing expires: Dec 31, 2027
Other FDA classes: Nicotine (Chemical structure)
Identifiers: Product ID 0536-3405_3f003626-da26-4e6c-9e31-edbd35c2d5b4SPL ID 3f003626-da26-4e6c-9e31-edbd35c2d5b4SPL set ID d67149d5-4766-4b84-8205-f1a6b692f4c9RxCUI 311975, 314119UNII 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. Buccal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400536340501 followed by a unit qualifier and the quantity

Package 00536-3405-01. 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 Jul 14, 2026.

Indications (excerpt from the label)

Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 079219

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 079219
Product	Strength	Form · route	Labeler	Product NDC
Nicotinenicotine polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Walgreens	0363-3911
Habitrol Nicotine Polacrilex 4 mg Coated Cinnamonnicotine polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Dr. Reddy's Laboratories Inc.	55741-001
Nicotinenicotine polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	McKesson Corporation dba SKY Packaging	63739-369
Nicotinenicotine polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Lucy Goods, Inc.	72224-930
Nicotine Polacrilex coated cinnamonnicotine polacrilex	Nicotine 4 mg/1	Gum, ChewingBuccal	CVS Pharmacy	69842-028
Nicotinenicotine polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	H E B	37808-821