NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0341Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0341Add 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
70000-0341-17000003410150 BLISTER PACK in 1 CARTON (70000-0341-1) / 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 OriginalSuffix: Original
Generic name (nonproprietary)
nicotine polacrilex
Active ingredients
Nicotine4 mg/1
Dosage form
Gum, Chewing
Route
Buccal
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074707
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 70000-0341_905563ef-1910-4436-a4cd-351213b503afSPL ID 905563ef-1910-4436-a4cd-351213b503afSPL set ID 4acbda22-9c87-49f2-ad5f-55b1e54bdf2eRxCUI 311975, 314119UNII 6M3C89ZY6RUPC 0096295133837, 0096295133844
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

N470000034101 followed by a unit qualifier and the quantity

Package 70000-0341-01. 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)

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