Over-the-counter drug · ANDA

Nicotine (Nicotine polacrilex) NDC 45802-651

Nicotine 4 mg/1 · Gum, Chewing · Oral · Padagis Israel Pharmaceuticals Ltd

NDC codes

FDA NDC Directory
Product NDC (as listed)45802-651Labeler and product segments. Claims need a package NDC.
Product NDC at billing width45802-0651Add 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
45802-651-254580206512545802065125110 BLISTER PACK in 1 CARTON (45802-651-25) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Aug 14, 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)
Nicotine
Generic name (nonproprietary)
nicotine polacrilex
Active ingredients
Nicotine — 4 mg/1
Dosage form
Gum, Chewing
Route
Oral
Labeler
Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206393
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 45802-651_e9554b2d-192b-4f07-87ca-c537b0c419baSPL ID e9554b2d-192b-4f07-87ca-c537b0c419baSPL set ID 26edb714-656d-49ca-b875-28972c490e5fRxCUI 311975UNII 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

N445802065125 followed by a unit qualifier and the quantity

Package 45802-0651-25. 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 45802-651

What is NDC 45802-651?
45802-651 is the product NDC for Nicotine (nicotine polacrilex), Nicotine 4 mg/1 gum, chewing, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nicotine (Nicotine polacrilex).
What is the active ingredient?
Nicotine.
Who is the labeler?
Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nicotine?
191 other product NDCs are listed under this name. See all 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 Nicotine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralAmazon.com Services LLC72288-68472288-0684-02
Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmazon.com Services LLC72288-73072288-0730-60
nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmazon.com Services LLC72288-75572288-0755-0672288-0755-60
Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmazon.com Services LLC72288-86372288-0863-06
Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralSafeway21130-77221130-0772-02
Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-96972288-0969-76
Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-86972288-0869-76
Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalCardinal Health 107, LLC55154-681855154-6818-00
nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-65172288-0651-14
Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWalgreen Company0363-251100363-2511-27

All 192 Nicotine NDCs

Other NDCs under ANDA 206393

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

FDA NDC Directory listings under ANDA 206393
ProductStrengthForm · routeLabelerProduct NDC
topcare nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralTopco Associates LLC36800-967
equate nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralWal-Mart Stores Inc49035-309
good sense nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralL. Perrigo Company0113-8600
nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralHyVee Inc42507-309
Coated Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralPublix Super Markets Inc56062-369
Good Sense Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralL. Perrigo Company0113-4111
nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralMeijer Distribution Inc41250-689
basic care nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmazon.com Services LLC72288-693
Good Sense Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralL. Perrigo Company0113-0053
nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmazon.com Services LLC72288-755
Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralA-S Medication Solutions50090-6674
good sense nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralA-S Medication Solutions50090-6695
foster and thrive nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralStrategic Sourcing Services LLC70677-1193
nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralWalgreen Company0363-2309
careone nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmerican Sales Company41520-843
Blipnicotine polacrilexNicotine 4 mg/1Gum, ChewingOralBlip Products, Inc.82966-309
quitine nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralQUITINE LLC84720-103
nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralKroger Company30142-848
blipnicotine polacrilexNicotine 4 mg/1Gum, ChewingOralBlip Products, Inc.82966-971
Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmazon.com Services LLC72288-863

Showing 20 of 39.

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