Over-the-counter drug · ANDA

Nicotine (Nicotine polacrilex) NDC 41250-456

Nicotine 2 mg/1 · Gum, Chewing · Oral · Meijer Distribution Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)41250-456Labeler and product segments. Claims need a package NDC.
Product NDC at billing width41250-0456Add 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
41250-456-064125004560641250045606160 BLISTER PACK in 1 CARTON (41250-456-06) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from May 4, 2007
41250-456-60412500456604125004566020 BLISTER PACK in 1 CARTON (41250-456-60) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jun 20, 2014
41250-456-704125004567041250045670240 BLISTER PACK in 1 CARTON (41250-456-70) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jun 3, 2011
41250-456-764125004567641250045676120 BLISTER PACK in 1 CARTON (41250-456-76) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Nov 7, 2007
41250-456-784125004567841250045678100 BLISTER PACK in 1 CARTON (41250-456-78) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Oct 31, 2006

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 — 2 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 076777
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 41250-456_d06119b1-1c60-4a98-9f45-64c5f3e7314aSPL ID d06119b1-1c60-4a98-9f45-64c5f3e7314aSPL set ID 6d86cb8f-018e-41be-a6d0-9ca30e731855RxCUI 314119UNII 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

N441250045606 followed by a unit qualifier and the quantity

Package 41250-0456-06. 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 41250-456

What is NDC 41250-456?
41250-456 is the product NDC for Nicotine (nicotine polacrilex), Nicotine 2 mg/1 gum, chewing, listed with the FDA by Meijer Distribution Inc. It has 5 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?
197 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 LLC72288-75572288-0755-06
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 198 Nicotine NDCs

Other NDCs under ANDA 076777

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

FDA NDC Directory listings under ANDA 076777
ProductStrengthForm · routeLabelerProduct NDC
Basic Care Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralAmazon.com Services LLC72288-456
Equate Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralWal-Mart Stores Inc49035-456
foster and thrive nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralStrategic Sourcing Services LLC70677-1170
Good Sense Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralL. Perrigo Company0113-0456
Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralWalgreen Company0363-0456
Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralRite Aid Corporation11822-0456
NicotineNicotine 2 mg/1Gum, ChewingOralH E B37808-682
quitine nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralQUITINE LLC84720-456
Topcare Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralTopco Associates LLC36800-456
up and up coated cool mint nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralTarget Corporation82442-456

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