Over-the-counter drug · ANDA

Nicotine Polacrilex Coated Mint (Nicotine polacrilex) NDC 68016-559

Nicotine 2 mg/1 · Gum, Chewing · Buccal · Chain Drug Consortium, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)68016-559Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68016-0559Add 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
68016-559-0068016055900680160559002 BLISTER PACK in 1 CARTON (68016-559-00) / 10 GUM, CHEWING in 1 BLISTER PACKMarketed from Oct 1, 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 Coated MintSuffix: Coated Mint
Generic name (nonproprietary)
nicotine polacrilex
Active ingredients
Nicotine — 2 mg/1
Dosage form
Gum, Chewing
Route
Buccal
Labeler
Chain Drug Consortium, LLCNDC labeler code 68016
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078699
Marketing start
Marketing end
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 68016-559_4004f343-1acc-48c7-a332-f0fbf9aca9b2SPL ID 4004f343-1acc-48c7-a332-f0fbf9aca9b2SPL set ID b4ac0a22-3556-4591-aa7b-e09c6010adc8RxCUI 311975, 314119UNII 6M3C89ZY6RUPC 0840986031090, 0840986029868, 0840986031106
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. Buccal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468016055900 followed by a unit qualifier and the quantity

Package 68016-0559-00. 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 68016-559

What is NDC 68016-559?
68016-559 is the product NDC for Nicotine Polacrilex Coated Mint (nicotine polacrilex), Nicotine 2 mg/1 gum, chewing, listed with the FDA by Chain Drug Consortium, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nicotine Polacrilex Coated Mint (Nicotine Polacrilex).
What is the active ingredient?
Nicotine.
Who is the labeler?
Chain Drug Consortium, LLC, NDC labeler code 68016. 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 Coated Mint?
11 other product NDCs are listed under this name. See all Nicotine Polacrilex Coated Mint 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 Coated Mint NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalCARDINAL HEALTH 110, LLC. DBA LEADER 7000070000-034370000-0343-01
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalCARDINAL HEALTH 110, LLC. DBA LEADER 7000070000-034770000-0347-01
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalChain Drug Consortium, LLC68016-56068016-0560-00
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalPublix Supermarkets, Inc.56062-42856062-0428-44
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalPublix Supermarkets, Inc.56062-42956062-0429-44
Nicotine Polacrilex coated mintnicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalCVS Pharmacy69842-42869842-0428-1669842-0428-2269842-0428-79
Nicotine Polacrilex coated mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalCVS Pharmacy69842-43069842-0430-1669842-0430-2269842-0430-79
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalChain Drug Consortium, LLC68016-28568016-0285-44
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalChain Drug Consortium, LLC68016-28068016-0280-49
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalChain Drug Consortium, LLC68016-28168016-0281-49

All 12 Nicotine Polacrilex Coated Mint NDCs

Other NDCs under ANDA 078699

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

FDA NDC Directory listings under ANDA 078699
ProductStrengthForm · routeLabelerProduct NDC
Habitrol Nicotine Polacrilex Gum 2 mg Coated Mintnicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalDr. Reddy's Laboratories Inc.75907-302
Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalRugby Laboratories0536-3112
Nicotine PolacrilexNicotine 2 mg/1Gum, ChewingOralWalgreens0363-9270
Nicotine PolacrilexNicotine 2 mg/1Gum, ChewingOralAmerisourceBergen (Good Neighbor Pharmacy) 4612246122-717
Nicotine PolacrilexNicotine 2 mg/1Gum, ChewingBuccalAAFES/Your Military Exchanges55301-428
Nicotine PolacrilexNicotine 2 mg/1Gum, ChewingOralRising Pharma Holdings, Inc.57237-322
Nicotine PolacrilexNicotine 2 mg/1Gum, ChewingOralLucy Goods, Inc.72224-927
Nicotine PolacrilexNicotine 2 mg/1Gum, ChewingOralQuitine LLC84720-927
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalPublix Supermarkets, Inc.56062-428
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalChain Drug Consortium, LLC68016-280
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalChain Drug Consortium, LLC68016-284
Nicotine Polacrilex coated mintnicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalCVS Pharmacy69842-428
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalCARDINAL HEALTH 110, LLC. DBA LEADER 7000070000-0347

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