Nicotine Polacrilex Coated Fruit NDC 70000-0346

NDC codes

FDA NDC Directory

Product NDC (as listed)70000-0346Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70000-0346Add 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 NDC	11-digit (billing)	Package	Copy
70000-0346-1	70000034601	20 BLISTER PACK in 1 CARTON (70000-0346-1) / 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 FruitSuffix: Coated Fruit
Generic name (nonproprietary): nicotine polacrilex
Active ingredients: Nicotine — 2 mg/1
Dosage form: Gum, Chewing
Route: Buccal
Labeler: CARDINAL HEALTH 110, LLC. DBA LEADER 70000
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 079044
Marketing start: Jul 3, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Nicotine (Chemical structure)
Identifiers: Product ID 70000-0346_8d31f88b-5a5c-4552-b2f8-0e44600c8594SPL ID 8d31f88b-5a5c-4552-b2f8-0e44600c8594SPL set ID d6c7a2ab-109d-40df-bce0-30c3531eb982RxCUI 311975, 314119UNII 6M3C89ZY6RUPC 0096295133776, 0096295133806
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

N470000034601 followed by a unit qualifier and the quantity

Package 70000-0346-01. 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 Apr 10, 2026.

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 079044

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

FDA NDC Directory listings under ANDA 079044
Product	Strength	Form · route	Labeler	Product NDC
Nicotine Polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	AAFES/Your Military Exchanges	55301-503
Nicotinenicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	Walgreens	0363-9250
Nicotine Polacrilex	Nicotine 2 mg/1	Gum, ChewingOral	Lucy Goods, Inc.	72224-925
Nicotine Polacrilex coated fruitnicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	CVS Pharmacy	69842-024
Nicotine Polacrilex Coated Fruitnicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	Publix Supermarkets, Inc.	56062-503
Habitrol Nicotine Polacrilex Gum 2 mg Coated Fruitnicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingOral	Dr. Reddy's Laboratories Inc.	75907-301
Nicotinenicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	P & L Development, LLC	59726-592
Rugby Nicotine Polacrilex Gum, Coated Fruit Flavornicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	Rugby Laboratories	0536-3386

Nicotine Polacrilex Coated Fruit (nicotine polacrilex) NDC 70000-0346