Over-the-counter drug · ANDA

Topcare Nicotine (Nicotine polacrilex) NDC 36800-734

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

NDC codes

FDA NDC Directory
Product NDC (as listed)36800-734Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0734Add 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
36800-734-02368000734023 CONTAINER in 1 CARTON (36800-734-02) / 27 LOZENGE in 1 CONTAINER (36800-734-01)Marketed from Feb 15, 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
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 203690
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 36800-734_cfed4776-31f3-4047-86af-67c2cb6fa16eSPL ID cfed4776-31f3-4047-86af-67c2cb6fa16eSPL set ID 17cf8f3d-6491-4cd8-a447-3c7533f76dafRxCUI 359817UNII 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

N436800073402 followed by a unit qualifier and the quantity

Package 36800-0734-02. 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 36800-734

What is NDC 36800-734?
36800-734 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 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?
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 2 mg/1LozengeOralTopco Associates LLC76162-40376162-0403-27
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 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 203690

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

FDA NDC Directory listings under ANDA 203690
ProductStrengthForm · routeLabelerProduct NDC
Basic Care Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-077
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-223
basic care nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-642
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-734
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-808
basic care nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-957
berkley and jensen nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralBJWC68391-734
berkley and jensen nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralBJWC68391-957
Blipnicotine polacrilexNicotine 2 mg/1LozengeOralBlip Products, Inc.82966-222
Blipnicotine polacrilexNicotine 4 mg/1LozengeOralBlip Products, Inc.82966-303
Blipnicotine polacrilexNicotine 2 mg/1LozengeOralBlip Products, Inc.82966-734
Blipnicotine polacrilexNicotine 4 mg/1LozengeOralBlip Products, Inc.82966-957
CareOne Mini Nicotine Polacrilexnicotine polacrilexNicotine 4 mg/1LozengeOralAmerican Sales Company41520-957
CareOne Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmerican Sales Company41520-734
Dg Health Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralDolgencorp Inc55910-669
Equate Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWal-Mart Stores Inc49035-734
equate nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWal-Mart Stores Inc49035-791
Equate nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWal-Mart Stores Inc49035-900
equate nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWALMART INC.79903-104
equate nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWALMART INC.79903-160

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