Over-the-counter drug · ANDA

nicotine (Nicotine polacrilex) NDC 41250-689

Nicotine 4 mg/1 · Gum, Chewing · Oral · Meijer Distribution Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)41250-689Labeler and product segments. Claims need a package NDC.
Product NDC at billing width41250-0689Add 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
41250-689-064125006890641250068906160 BLISTER PACK in 1 CARTON (41250-689-06) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 3, 2020
41250-689-60412500689604125006896020 BLISTER PACK in 1 CARTON (41250-689-60) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Dec 18, 2019
41250-689-784125006897841250068978100 BLISTER PACK in 1 CARTON (41250-689-78) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Dec 21, 2019

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
Meijer Distribution IncNDC labeler code 41250
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 41250-689_77c4b21f-d51f-4909-af11-b61b1cb2d980SPL ID 77c4b21f-d51f-4909-af11-b61b1cb2d980SPL set ID 860f8306-4cd4-4444-8c6e-182ddeb10ad6RxCUI 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

N441250068906 followed by a unit qualifier and the quantity

Package 41250-0689-06. 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 41250-689

What is NDC 41250-689?
41250-689 is the product NDC for nicotine (nicotine polacrilex), Nicotine 4 mg/1 gum, chewing, listed with the FDA by Meijer Distribution Inc. It has 3 package NDCs, 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?
Meijer Distribution Inc, NDC labeler code 41250. 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
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, ChewingOralPadagis Israel Pharmaceuticals Ltd45802-651
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

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