Nicotine (nicotine polacrilex) NDC 0363-9580

NDC codes

FDA NDC Directory

Product NDC (as listed)0363-9580Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00363-9580Add 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
0363-9580-08	00363958008	4 BOTTLE, PLASTIC in 1 BOX (0363-9580-08) / 27 LOZENGE in 1 BOTTLE, PLASTICMarketed from May 28, 2021
0363-9580-24	00363958024	1 BOTTLE, PLASTIC in 1 BOX (0363-9580-24) / 24 LOZENGE in 1 BOTTLE, PLASTICMarketed from May 28, 2021
0363-9580-27	00363958027	1 BOTTLE, PLASTIC in 1 BOX (0363-9580-27) / 27 LOZENGE in 1 BOTTLE, PLASTICMarketed from May 28, 2021
0363-9580-44	00363958044	6 BOTTLE, PLASTIC in 1 BOX (0363-9580-44) / 24 LOZENGE in 1 BOTTLE, PLASTICMarketed from May 28, 2021

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: Lozenge
Route: Oral
Labeler: Walgreens
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209206
Marketing start: May 28, 2021
Marketing end: May 28, 2027
Other FDA classes: Nicotine (Chemical structure)
Identifiers: Product ID 0363-9580_9e0dc481-384d-4c7b-a752-c0e75c3bc4f5SPL ID 9e0dc481-384d-4c7b-a752-c0e75c3bc4f5SPL set ID 49a8e4f0-2b4c-4928-98f8-c8f9bb17c0f4RxCUI 359818UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400363958008 followed by a unit qualifier and the quantity

Package 00363-9580-08. 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 Jan 20, 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 209206

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

FDA NDC Directory listings under ANDA 209206
Product	Strength	Form · route	Labeler	Product NDC
Nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	AmerisourceBergen (Good Neighbor Pharmacy) 46122	46122-734
Maxi Nicotinenicotine polacrilex	Nicotine 4 mg/1	LozengeOral	Rite Aid Corporation	11822-3317
Nicotine Sugar Freenicotine polacrilex	Nicotine 4 mg/1	LozengeOral	CVS Pharmacy	69842-858
Nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	Cardinal Health (Leader) 70000	70000-0562
Maxi Nicotinenicotine polacrilex	Nicotine 4 mg/1	LozengeOral	Cardinal Health (Leader) 70000	70000-0561
Nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	Rugby Laboratories, Inc.	0536-1337
Maxi Nicotinenicotine polacrilex	Nicotine 4 mg/1	LozengeOral	Rugby Laboratories, Inc.	0536-1338
Nicotine Sugar Freenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	CVS Pharmacy	69842-957
Nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	Walgreens	0363-9570
Nicotinenicotine polacrilex	Nicotine 4 mg/1	LozengeOral	AmerisourceBergen (Good Neighbor Pharmacy) 46122	46122-732