Over-the-counter drug · ANDA

nicotine (Nicotine polacrilex) NDC 42507-309

Nicotine 4 mg/1 · Gum, Chewing · Oral · HyVee Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)42507-309Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42507-0309Add 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
42507-309-7842507030978100 BLISTER PACK in 1 CARTON (42507-309-78) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Feb 25, 2026

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
Gum, Chewing
Route
Oral
Labeler
HyVee IncNDC labeler code 42507
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206393
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 42507-309_b2dae2b5-497e-4a90-ad3c-4429ee87f1daSPL ID b2dae2b5-497e-4a90-ad3c-4429ee87f1daSPL set ID 9087e72a-6061-4b11-b41d-c9bfd2c20ec3RxCUI 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

N442507030978 followed by a unit qualifier and the quantity

Package 42507-0309-78. 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 42507-309

What is NDC 42507-309?
42507-309 is the product NDC for nicotine (nicotine polacrilex), Nicotine 4 mg/1 gum, chewing, listed with the FDA by HyVee Inc. It has 1 package NDC, 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?
HyVee Inc, NDC labeler code 42507. 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?
194 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 LLC72288-73072288-0730-60
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/1LozengeOralSixarp, LLC59368-46359368-0463-02

All 195 nicotine NDCs

Other NDCs under ANDA 206393

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

FDA NDC Directory listings under ANDA 206393
ProductStrengthForm · routeLabelerProduct NDC
Basic Care Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmazon.com Services LLC72288-003
basic care nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmazon.com Services LLC72288-577
basic care nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmazon.com Services LLC72288-693
Berkley and Jensen Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralBJWC68391-309
Blipnicotine polacrilexNicotine 4 mg/1Gum, ChewingOralBlip Products, Inc.82966-309
blipnicotine polacrilexNicotine 4 mg/1Gum, ChewingOralBlip Products, Inc.82966-971
careone nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmerican Sales Company41520-843
Coated Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralPublix Super Markets Inc56062-369
equate nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralWal-Mart Stores Inc49035-309
foster and thrive nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralStrategic Sourcing Services LLC70677-1193
Good Sense Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralL. Perrigo Company0113-0053
Good Sense Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralL. Perrigo Company0113-4111
good sense nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralL. Perrigo Company0113-8600
good sense nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralA-S Medication Solutions50090-6695
kirkland signature quit 4nicotine polacrilexNicotine 4 mg/1Gum, ChewingOralCostco Wholesale Company63981-309
members mark nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralSam's West Inc68196-309
Members Mark Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralSam's West Inc68196-971
nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralWalgreen Company0363-2309
nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralWalgreen Company0363-7103
nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralWalgreen Company0363-7971

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