NDC codes

FDA NDC Directory
Product NDC (as listed)11822-0201Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11822-0201Add 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
11822-0201-0118220201003 CONTAINER in 1 CARTON (11822-0201-0) / 24 LOZENGE in 1 CONTAINER (11822-0201-1)Marketed from Dec 11, 2020

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
Generic name (nonproprietary)
nicotine polacrilex
Active ingredients
Nicotine — 2 mg/1
Dosage form
Lozenge
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090821
Marketing start
Marketing end
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 11822-0201_a7ac4d1e-d6aa-409c-b5d0-aa3142f1eb43SPL ID a7ac4d1e-d6aa-409c-b5d0-aa3142f1eb43SPL set ID cd17f3b4-dddd-4387-9fb1-1efa32ba1d2bRxCUI 359817UNII 6M3C89ZY6RUPC 0012345678905
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

N411822020100 followed by a unit qualifier and the quantity

Package 11822-0201-00. 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)

Other NDCs under ANDA 090821

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

FDA NDC Directory listings under ANDA 090821
ProductStrengthForm · routeLabelerProduct NDC
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralCVS Pharmacy59779-201
nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralCVS Pharmacy59779-424
Equate Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWal-Mart Stores Inc49035-702
nicotinenicotine polarilexNicotine 2 mg/1LozengeOralMeijer Distribution Inc41250-201
nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralRite Aid Corporation11822-0424
Equate Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWal-Mart Stores Inc49035-201
foster and thrive nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralStrategic Sourcing Services LLC70677-1174
foster and thrive nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralStrategic Sourcing Services LLC70677-1175
Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralMeijer Distribution Inc41250-424
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWalgreen Company0363-0201
Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWalgreen Company0363-0424

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