Over-the-counter drug · ANDA

Nicotine Polacrilex Coated Mint (Nicotine polacrilex) NDC 70000-0343

Nicotine 4 mg/1 · Gum, Chewing · Buccal · CARDINAL HEALTH 110, LLC. DBA LEADER 70000

NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0343Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0343Add 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
70000-0343-1700000343017000003430110 BLISTER PACK in 1 CARTON (70000-0343-1) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jul 3, 2018

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 4 mg/1
Dosage form
Gum, Chewing
Route
Buccal
Labeler
CARDINAL HEALTH 110, LLC. DBA LEADER 70000NDC labeler code 70000
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078697
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 70000-0343_7b8f2279-83c7-4b39-bf76-ca081ba91b25SPL ID 7b8f2279-83c7-4b39-bf76-ca081ba91b25SPL set ID 2c420ee4-0ed0-4a3f-bc92-202d825d0ca3RxCUI 311975, 314119UNII 6M3C89ZY6RUPC 0096295133752, 0096295133790
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

N470000034301 followed by a unit qualifier and the quantity

Package 70000-0343-01. 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 70000-0343

What is NDC 70000-0343?
70000-0343 is the product NDC for Nicotine Polacrilex Coated Mint (nicotine polacrilex), Nicotine 4 mg/1 gum, chewing, listed with the FDA by CARDINAL HEALTH 110, LLC. DBA LEADER 70000. 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?
CARDINAL HEALTH 110, LLC. DBA LEADER 70000, NDC labeler code 70000. 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 2 mg/1Gum, ChewingBuccalCARDINAL HEALTH 110, LLC. DBA LEADER 7000070000-034770000-0347-01
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalChain Drug Consortium, LLC68016-55968016-0559-00
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 078697

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

FDA NDC Directory listings under ANDA 078697
ProductStrengthForm · routeLabelerProduct NDC
Habitrol Nicotine Polacrilex Gum 4 mg Coated Mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingOralDr. Reddy's Laboratories Inc.75907-303
Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalRugby Laboratories0536-3113
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralWalgreens0363-9330
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralAmerisourceBergen (Good Neighbor Pharmacy) 4612246122-718
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralA-S Medication Solutions50090-8146
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingBuccalAAFES/Your Military Exchanges55301-429
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-796
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-976
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralRising Pharma Holdings, Inc.57237-323
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralLucy Goods, Inc.72224-933
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralQuitine LLC84720-933
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalPublix Supermarkets, Inc.56062-429
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalChain Drug Consortium, LLC68016-281
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalChain Drug Consortium, LLC68016-285
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalChain Drug Consortium, LLC68016-560
Nicotine Polacrilex coated mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalCVS Pharmacy69842-430

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