Over-the-counter drug · ANDA

Nicotine (Nicotine polacrilex) NDC 41250-957

Nicotine 4 mg/1 · Lozenge · Oral · Meijer Distribution Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)41250-957Labeler and product segments. Claims need a package NDC.
Product NDC at billing width41250-0957Add 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
41250-957-02412500957023 CONTAINER in 1 CARTON (41250-957-02) / 27 LOZENGE in 1 CONTAINERMarketed from Jan 18, 2013
41250-957-60412500957601 CONTAINER in 1 CARTON (41250-957-60) / 20 LOZENGE in 1 CONTAINERMarketed from Apr 24, 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
Lozenge
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 203690
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 41250-957_c0f1a0c4-802c-447a-abc9-66c6498919b3SPL ID c0f1a0c4-802c-447a-abc9-66c6498919b3SPL set ID dc70703e-2c55-4178-a5d5-50f762ab6492RxCUI 359818UNII 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

N441250095702 followed by a unit qualifier and the quantity

Package 41250-0957-02. 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 41250-957

What is NDC 41250-957?
41250-957 is the product NDC for Nicotine (nicotine polacrilex), Nicotine 4 mg/1 lozenge, listed with the FDA by Meijer Distribution Inc. It has 2 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?
196 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 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
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-88872288-0888-14
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralSixarp, LLC59368-46359368-0463-02

All 197 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
Nicotine PolacrilexNicotine 4 mg/1LozengeOralBryant Ranch Prepack71335-2730
Nicotine PolacrilexNicotine 2 mg/1LozengeOralBryant Ranch Prepack71335-2729
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-734
exchange select nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralArmy & Air Force Exchange Service55301-957
Equate Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWal-Mart Stores Inc49035-734
Nicotine Mininicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-739
up and up citrus mini nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralTarget Corporation82442-023
Nicotine Mininicotine polacrilexNicotine 4 mg/1LozengeOralKroger Company30142-209
nicotine mininicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-797
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-808
equate nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWALMART INC.79903-160
nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralH E B37808-563
CareOne Mini Nicotine Polacrilexnicotine polacrilexNicotine 4 mg/1LozengeOralAmerican Sales Company41520-957
equate nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWal-Mart Stores Inc49035-791
Nicotine PolacrilexNicotine 2 mg/1LozengeOralPadagis Israel Pharmaceuticals Ltd45802-089
Nicotine PolacrilexNicotine 2 mg/1LozengeOralBryant Ranch Prepack72162-2287
Nicotine PolacrilexNicotine 4 mg/1LozengeOralBryant Ranch Prepack72162-2288
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-223
up and up citrus mini nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralTarget Corporation82442-399
Topcare Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralTopco Associates LLC36800-734

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