Nicotine (nicotine polacrilex) NDC 51316-787

NDC codes

FDA NDC Directory

Product NDC (as listed)51316-787Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51316-0787Add 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
51316-787-60	51316078760	1 CONTAINER in 1 CARTON (51316-787-60) / 20 LOZENGE in 1 CONTAINERMarketed from Aug 4, 2026

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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: CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077007
Marketing start: Aug 4, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Nicotine (Chemical structure)
Identifiers: Product ID 51316-787_2f80c43a-8b04-42aa-ae89-50266b74f4b3SPL ID 2f80c43a-8b04-42aa-ae89-50266b74f4b3SPL set ID 9ba85e0a-bcb7-4803-8d21-0eb93768cb3aRxCUI 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

N451316078760 followed by a unit qualifier and the quantity

Package 51316-0787-60. 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 Aug 7, 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 077007

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

FDA NDC Directory listings under ANDA 077007
Product	Strength	Form · route	Labeler	Product NDC
Nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	HyVee Inc	42507-344
nicotinenicotine polacrilex	Nicotine 4 mg/1	LozengeOral	Walgreen Company	0363-7044
nicotine polacrilexnicotine	Nicotine 4 mg/1	LozengeOral	H E B	37808-948
Good Sense Nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	L. Perrigo Company	0113-2502
nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	Sixarp, LLC	59368-463
nicotinenicotine polacrilex	Nicotine 4 mg/1	LozengeOral	Amazon.com Services LLC	72288-651
good sense nicotinenicotine polacrilex	Nicotine 4 mg/1	LozengeOral	A-S Medication Solutions	50090-7060
Good Sense Nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	A-S Medication Solutions	50090-7061
careone nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	American Sales Company	41520-701
Nicotinenicotine polacrilex	Nicotine 4 mg/1	LozengeOral	HyVee Inc	42507-690
Nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	CVS Pharmacy	59779-344
kirkland signature quit 2nicotine polacrilex	Nicotine 2 mg/1	LozengeOral	Costco Wholesale Company	63981-344
Nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	Rite Aid Corporation	11822-0344
Nicotinenicotine polacrilex	Nicotine 4 mg/1	LozengeOral	Safeway	21130-636
exchange select nicotinenicotine polacrilex	Nicotine 4 mg/1	LozengeOral	Army & Air Force Exchange Service	55301-873
Nicotinenicotine polacrilex	Nicotine 4 mg/1	LozengeOral	Kroger Company	30142-873
Nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	H E B	59640-099
Nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	51316-319
kirkland signature quit 4nicotine polacrilex	Nicotine 4 mg/1	LozengeOral	Costco Wholesale Company	63981-873
Nicotinenicotine polacrilex	Nicotine 4 mg/1	LozengeOral	H E B	59640-151

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