NDC codes

FDA NDC Directory
Product NDC (as listed)45802-089Labeler and product segments. Claims need a package NDC.
Product NDC at billing width45802-0089Add 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
45802-089-0245802008902458020089023 CONTAINER in 1 CARTON (45802-089-02) / 27 LOZENGE in 1 CONTAINER (45802-089-01)Marketed from Jul 8, 2016

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 Polacrilex
Generic name (nonproprietary)
nicotine polacrilex
Active ingredients
Nicotine — 2 mg/1
Dosage form
Lozenge
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 203690
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 45802-089_b0db32b2-4ace-4fbe-a319-029ce7d54251SPL ID b0db32b2-4ace-4fbe-a319-029ce7d54251SPL set ID b765570e-e5b5-48e4-b4d2-2a85ac19a2eaRxCUI 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

N445802008902 followed by a unit qualifier and the quantity

Package 45802-0089-02. 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 45802-089

What is NDC 45802-089?
45802-089 is the product NDC for Nicotine Polacrilex, Nicotine 2 mg/1 lozenge, 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 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 Polacrilex?
46 other product NDCs are listed under this name. See all Nicotine Polacrilex 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 Polacrilex NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Nicotine PolacrilexNicotine 2 mg/1Gum, ChewingOralLucy Goods, Inc.72224-92472224-0924-10
Nicotine PolacrilexNicotine 2 mg/1Gum, ChewingOralLucy Goods, Inc.72224-92572224-0925-10
Nicotine PolacrilexNicotine 2 mg/1Gum, ChewingOralLucy Goods, Inc.72224-92772224-0927-10
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralLucy Goods, Inc.72224-93372224-0933-10
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-97655910-0976-20
Nicotine PolacrilexNicotine 2 mg/1Gum, ChewingOralQuitine LLC84720-92784720-0927-03
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralQuitine LLC84720-93384720-0933-03
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-79655910-0796-20
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-93355910-0933-10
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralA-S Medication Solutions50090-814650090-8146-00

All 47 Nicotine Polacrilex 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
Up and Up Mini Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralTarget Corporation82442-802
members mark nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralSam's West Inc68196-084
up and up citrus mini nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralTarget Corporation82442-399
nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralPublix Super Markets Inc56062-957
Nicotine Mininicotine polacrilexNicotine 4 mg/1LozengeOralKroger Company30142-209
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-223
nicotine mininicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-789
nicotine mininicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-797
Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralMeijer Distribution Inc41250-957
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-808
nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralH E B37808-563
Good Sense Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralL. Perrigo Company0113-0957
up and up mint mini nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralTarget Corporation82442-734
Equate Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWal-Mart Stores Inc49035-734
mini nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralMeijer, Inc.79481-0734
members mark Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralSam's West Inc68196-734
nicotineNicotine 4 mg/1LozengeOralCVS Pharmacy69842-828
members mark nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralSam's West Inc68196-811
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralH E B37808-617
Topcare Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralTopco Associates LLC36800-734

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