Over-the-counter drug · ANDA

kirkland signature quit 4 (Nicotine polacrilex) NDC 63981-309

Nicotine 4 mg/1 · Gum, Chewing · Oral · Costco Wholesale Company

NDC codes

FDA NDC Directory
Product NDC (as listed)63981-309Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63981-0309Add 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
63981-309-476398103094763981030947150 BLISTER PACK in 1 CARTON (63981-309-47) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Mar 21, 2017
63981-309-8763981030987639810309872 CARTON in 1 PACKAGE (63981-309-87) / 150 BLISTER PACK in 1 CARTON / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Mar 21, 2017

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)
kirkland signature quit 4
Generic name (nonproprietary)
nicotine polacrilex
Active ingredients
Nicotine — 4 mg/1
Dosage form
Gum, Chewing
Route
Oral
Labeler
Costco Wholesale CompanyNDC labeler code 63981
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 63981-309_40fdca35-6979-484d-ab3b-77c97ab84434SPL ID 40fdca35-6979-484d-ab3b-77c97ab84434SPL set ID bfdf3918-3116-4351-b0a8-4c515e2e1f41RxCUI 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

N463981030947 followed by a unit qualifier and the quantity

Package 63981-0309-47. 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 63981-309

What is NDC 63981-309?
63981-309 is the product NDC for kirkland signature quit 4 (nicotine polacrilex), Nicotine 4 mg/1 gum, chewing, listed with the FDA by Costco Wholesale Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
kirkland signature quit 4 (Nicotine Polacrilex).
What is the active ingredient?
Nicotine.
Who is the labeler?
Costco Wholesale Company, NDC labeler code 63981. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for kirkland signature quit 4?
2 other product NDCs are listed under this name. See all kirkland signature quit 4 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 kirkland signature quit 4 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
kirkland signature quit 4nicotine polacrilexNicotine 4 mg/1LozengeOralCostco Wholesale Company63981-87363981-0873-37
kirkland signature quit 4nicotine polacrilexNicotine 4 mg/1Gum, ChewingOralCostco Wholesale Company63981-17063981-0170-0163981-0170-56

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
topcare nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralTopco Associates LLC36800-967
equate nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralWal-Mart Stores Inc49035-309
good sense nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralL. Perrigo Company0113-8600
nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralHyVee Inc42507-309
Coated Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralPublix Super Markets Inc56062-369
Good Sense Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralL. Perrigo Company0113-4111
nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralMeijer Distribution Inc41250-689
basic care nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmazon.com Services LLC72288-693
Good Sense Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralL. Perrigo Company0113-0053
Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralPadagis Israel Pharmaceuticals Ltd45802-651
nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmazon.com Services LLC72288-755
Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralA-S Medication Solutions50090-6674
good sense nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralA-S Medication Solutions50090-6695
foster and thrive nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralStrategic Sourcing Services LLC70677-1193
nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralWalgreen Company0363-2309
careone nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmerican Sales Company41520-843
Blipnicotine polacrilexNicotine 4 mg/1Gum, ChewingOralBlip Products, Inc.82966-309
quitine nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralQUITINE LLC84720-103
nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralKroger Company30142-848
blipnicotine polacrilexNicotine 4 mg/1Gum, ChewingOralBlip Products, Inc.82966-971

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