NDC codes

FDA NDC Directory
Product NDC (as listed)0363-7269Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-7269Add 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
0363-7269-0600363726906160 BLISTER PACK in 1 CARTON (0363-7269-06) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from May 28, 2019
0363-7269-600036372696020 BLISTER PACK in 1 CARTON (0363-7269-60) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from May 28, 2019
0363-7269-7800363726978100 BLISTER PACK in 1 CARTON (0363-7269-78) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from May 24, 2019

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
Generic name (nonproprietary)
nicotine polacrilex
Active ingredients
Nicotine2 mg/1
Dosage form
Gum, Chewing
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206394
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 0363-7269_ebcf227f-597d-449c-9ae5-b505f04261e2SPL ID ebcf227f-597d-449c-9ae5-b505f04261e2SPL set ID 97fefc42-5c9d-453e-a0b6-dc7aac5ee8e1RxCUI 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

N400363726906 followed by a unit qualifier and the quantity

Package 00363-7269-06. 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)

Other NDCs under ANDA 206394

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

FDA NDC Directory listings under ANDA 206394
ProductStrengthForm · routeLabelerProduct NDC
Topcare Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralTopco Associates LLC36800-460
up and up uncoated mint nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralTarget Corporation82442-899
good sense nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralL. Perrigo Company0113-8100
nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralKroger Company30142-749
Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralWalgreen Company0363-7050
nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralMeijer, Inc.79481-0755
Good Sense Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralL. Perrigo Company0113-6020
Kirkland Signature Quit 2nicotine polacrilexNicotine 2 mg/1Gum, ChewingOralCostco Wholesale Company63981-012
good sense nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralA-S Medication Solutions50090-7063
nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralRite Aid Corporation11822-0269
careone nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralAmerican Sales Company41520-711
Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralMeijer Distribution Inc41250-209
coated nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralPublix Super Markets Inc56062-110
Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralKroger Company30142-208
basic care nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralAmazon.com Services LLC72288-811
Blipnicotine polacrilexNicotine 2 mg/1Gum, ChewingOralBlip Products, Inc.82966-269
Blipnicotine polacrilexNicotine 2 mg/1Gum, ChewingOralBlip Products, Inc.82966-012
Basic Care Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralAmazon.com Services LLC72288-292
nictoine gumnicotine polacrilexNicotine 2 mg/1Gum, ChewingOralRite Aid Corporation11822-0904
signature care nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralSafeway21130-186

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