Over-the-counter drug · ANDA

Topcare Nicotine (Nicotine polacrilex) NDC 76162-403

Nicotine 2 mg/1 · Lozenge · Oral · Topco Associates LLC

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 NDC11-digit (billing)PackageCopy
76162-403-27761620403272 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 LLCNDC labeler code 76162
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077007
Marketing start
Listing expires
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 .

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 76162-403

What is NDC 76162-403?
76162-403 is the product NDC for Topcare Nicotine (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 (Nicotine Polacrilex).
What is the active ingredient?
Nicotine.
Who is the labeler?
Topco Associates LLC, NDC labeler code 76162. 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?
14 other product NDCs are listed under this name. See all Topcare Nicotine NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Topcare Nicotine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Topcare Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralTopco Associates LLC36800-46036800-0460-25
topcare nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralTopco Associates LLC76162-70076162-0700-2776162-0700-58
topcare nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralTopco Associates LLC36800-26936800-0269-78
topcare nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralTopco Associates LLC36800-96736800-0967-78
Topcare Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralTopco Associates LLC36800-65036800-0650-6036800-0650-78
Topcare Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralTopco Associates LLC36800-86336800-0863-78
Topcare Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralTopco Associates LLC36800-73436800-0734-02
Topcare Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralTopco Associates LLC36800-95736800-0957-02
Topcare Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralTopco Associates LLC36800-53936800-0539-05
Topcare Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralTopco Associates LLC36800-87336800-0873-0536800-0873-06

All 15 Topcare Nicotine NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-344
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-492
basic care nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-509
basic care nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-873
berkley and jensen nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralBJWC68391-344
berkley and jensen nicotine polacrilexnicotine polacrilexNicotine 4 mg/1LozengeOralBJWC68391-873
care one nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmerican Sales Company41520-873
careone nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmerican Sales Company41520-701
equate nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWal-Mart Stores Inc49035-873
Equate Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWal-Mart Stores Inc49035-998
equate nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWALMART INC.79903-182
Equate Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWALMART INC.79903-353
Equate Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWALMART INC.79903-354
euqate nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWALMART INC.79903-101
exchange select nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralArmy & Air Force Exchange Service55301-617
exchange select nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralArmy & Air Force Exchange Service55301-873
foster and thrive nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralStrategic Sourcing Services LLC70677-1176
foster and thrive nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralStrategic Sourcing Services LLC70677-1177
Good Sense Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralL. Perrigo Company0113-0344
good sense nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralL. Perrigo Company0113-0873

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