What is NDC 36800-375?

36800-375 is the product NDC for topcare nicotine polacrilex (nicotine polacrilex), Nicotine 2 mg/1 lozenge, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

topcare nicotine polacrilex (Nicotine Polacrilex).

Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for topcare nicotine polacrilex?

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.

topcare nicotine polacrilex NDC 36800-375

NDC codes

FDA NDC Directory

Product NDC (as listed)36800-375Labeler and product segments. Claims need a package NDC.

Product NDC at billing width36800-0375Add 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
36800-375-05	3680003750536800037505	3 CONTAINER in 1 CARTON (36800-375-05) / 24 LOZENGE in 1 CONTAINER (36800-375-03)Marketed from Feb 13, 2013

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 polacrilex
Generic name (nonproprietary): nicotine polacrilex
Active ingredients: Nicotine — 2 mg/1
Dosage form: Lozenge
Route: Oral
Labeler: Topco Associates LLCNDC labeler code 36800
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090711
Marketing start: Jun 22, 1998
Listing expires: Dec 31, 2027
Other FDA classes: Nicotine (Chemical structure)
Identifiers: Product ID 36800-375_6a0be9fe-8359-4fce-a4bf-cfc3f6832a23SPL ID 6a0be9fe-8359-4fce-a4bf-cfc3f6832a23SPL set ID d0403746-f866-42da-ad66-2a686c8bce01RxCUI 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

N436800037505 followed by a unit qualifier and the quantity

Package 36800-0375-05. 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 Feb 11, 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)

About NDC 36800-375

What is NDC 36800-375?: 36800-375 is the product NDC for topcare nicotine polacrilex (nicotine polacrilex), Nicotine 2 mg/1 lozenge, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: topcare nicotine polacrilex (Nicotine Polacrilex).
What is the active ingredient?: Nicotine.
Who is the labeler?: Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for topcare nicotine polacrilex?: 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.

Other NDCs under ANDA 090711

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

FDA NDC Directory listings under ANDA 090711
Product	Strength	Form · route	Labeler	Product NDC
Kirkland Signature Nicotinenicotine	Nicotine 4 mg/1	LozengeOral	Costco Wholesale Company	63981-190
Nicotinenicotine polacrilex	Nicotine 4 mg/1	LozengeOral	Kroger Company	30142-190
up and up cherry nicotinenicotine polacrilex	Nicotine 4 mg/1	LozengeOral	Target Corporation	82442-190
nicotine	Nicotine 2 mg/1	LozengeOral	H E B	37808-533
Kirkland Signature Nicotinenicotine	Nicotine 2 mg/1	LozengeOral	Costco Wholesale Company	63981-124
Nicotinenicotine polacrilex	Nicotine 4 mg/1	LozengeOral	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	51316-190
equate nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	Wal-Mart Stores Inc	49035-124
Nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	CVS Pharmacy	59779-397
Equate Nicotinenicotine polacrilex	Nicotine 4 mg/1	LozengeOral	Wal-Mart Stores Inc	49035-190
Nicotinenicotine polacrilex	Nicotine 4 mg/1	LozengeOral	Walgreen Company	0363-4190
nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	Meijer Distribution Inc	41250-700
Good Sense Nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	L. Perrigo Company	0113-1125
nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	Publix Super Markets Inc	56062-499
nicotinenicotine polacrilex	Nicotine 4 mg/1	LozengeOral	Publix Super Markets Inc	56062-509
basic care nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	Amazon.com Services LLC	72288-124
nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	Walgreen Company	0363-0124
Quitine Nicotinenicotine polacrilex	Nicotine 4 mg/1	LozengeOral	QUITINE LLC	84720-190
nicotine	Nicotine 4 mg/1	LozengeOral	H E B	37808-383
Quitine nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	QUITINE LLC	84720-124
good sense nicotinenicotine polacrilex	Nicotine 4 mg/1	LozengeOral	L. Perrigo Company	0113-1190

Showing 20 of 27.

topcare nicotine polacrilex (Nicotine polacrilex) NDC 36800-375