NDC codes

FDA NDC Directory
Product NDC (as listed)0363-3290Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-3290Add 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
0363-3290-100036332901000363329010100 BLISTER PACK in 1 CARTON (0363-3290-10) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Oct 30, 2020

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Gum, Chewing
Route
Oral
Labeler
WalgreensNDC labeler code 0363
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204833
Marketing start
Marketing end
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 0363-3290_2cd7b668-4c0b-4511-b3db-f83f333c9799SPL ID 2cd7b668-4c0b-4511-b3db-f83f333c9799SPL set ID 5741531a-3886-4b0a-ae92-d7c238488fdfRxCUI 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

N400363329010 followed by a unit qualifier and the quantity

Package 00363-3290-10. 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 0363-3290

What is NDC 0363-3290?
0363-3290 is the product NDC for Nicotine Polacrilex, Nicotine 4 mg/1 gum, chewing, listed with the FDA by Walgreens. 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?
Walgreens, NDC labeler code 0363. 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?
48 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.72224-92772224-0927-10
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 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 49 Nicotine Polacrilex NDCs

Other NDCs under ANDA 204833

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

FDA NDC Directory listings under ANDA 204833
ProductStrengthForm · routeLabelerProduct NDC
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralFamily Dollar (FAMILY WELLNESS)55319-966
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-933
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingBuccalChain Drug Consortium, LLC68016-293
Nicotine Polacrilex coated ice mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalAmerisourceBergen (Good Neighbor Pharmacy) 4612246122-449
Nicotine Polacrilex coated ice mintnicotine polacrilex gumNicotine 4 mg/1Gum, ChewingBuccalCVS Pharmacy69842-217
Nicotine Polacrilex Coated Ice Mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalCARDINAL HEALTH 110, LLC. DBA LEADER 7000070000-0344

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