Topcare Nicotine (nicotine polacrilex) NDC 76162-403

NDC codes

FDA NDC Directory

Product NDC (as listed)76162-403Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76162-0403Add 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
76162-403-27	76162040327	2 CONTAINER in 1 CARTON (76162-403-27) / 40 LOZENGE in 1 CONTAINER (76162-403-58)Marketed from Jun 30, 2023

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): Topcare Nicotine
Generic name (nonproprietary): nicotine polacrilex
Active ingredients: Nicotine — 2 mg/1
Dosage form: Lozenge
Route: Oral
Labeler: Topco Associates LLC
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077007
Marketing start: Jun 30, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Nicotine (Chemical structure)
Identifiers: Product ID 76162-403_25aba504-b4ce-473d-862b-c878189a50a9SPL ID 25aba504-b4ce-473d-862b-c878189a50a9SPL set ID a0ceda92-78e7-417f-adfc-a085f9b18584RxCUI 359817UNII 6M3C89ZY6RUPC 0012345678905
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

N476162040327 followed by a unit qualifier and the quantity

Package 76162-0403-27. 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 28, 2023.

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
Nicotinenicotine polacrilex	Nicotine 4 mg/1	LozengeOral	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	51316-787
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

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