NDC codes

FDA NDC Directory
Product NDC (as listed)45802-873Labeler and product segments. Claims need a package NDC.
Product NDC at billing width45802-0873Add 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
45802-873-0545802087305458020873053 CONTAINER in 1 CARTON (45802-873-05) / 24 LOZENGE in 1 CONTAINER (45802-873-03)Marketed from Mar 31, 2014

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 — 4 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 077007
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 45802-873_574b2fe4-a95b-400d-a107-4658e84f7d87SPL ID 574b2fe4-a95b-400d-a107-4658e84f7d87SPL set ID 8d4dfba9-1571-4128-9cdc-47cdce04e3e4RxCUI 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

N445802087305 followed by a unit qualifier and the quantity

Package 45802-0873-05. 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 45802-873

What is NDC 45802-873?
45802-873 is the product NDC for Nicotine Polacrilex, Nicotine 4 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 077007

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

FDA NDC Directory listings under ANDA 077007
ProductStrengthForm · routeLabelerProduct NDC
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-344
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-492
basic care nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-509
basic care nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-873
berkley and jensen nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralBJWC68391-344
berkley and jensen nicotine polacrilexnicotine polacrilexNicotine 4 mg/1LozengeOralBJWC68391-873
care one nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmerican Sales Company41520-873
careone nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmerican Sales Company41520-701
equate nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWal-Mart Stores Inc49035-873
Equate Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWal-Mart Stores Inc49035-998
equate nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWALMART INC.79903-182
Equate Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWALMART INC.79903-353
Equate Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWALMART INC.79903-354
euqate nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWALMART INC.79903-101
exchange select nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralArmy & Air Force Exchange Service55301-617
exchange select nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralArmy & Air Force Exchange Service55301-873
foster and thrive nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralStrategic Sourcing Services LLC70677-1176
foster and thrive nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralStrategic Sourcing Services LLC70677-1177
Good Sense Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralL. Perrigo Company0113-0344
good sense nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralL. Perrigo Company0113-0873

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