NDC codes

FDA NDC Directory
Product NDC (as listed)55301-734Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55301-0734Add 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
55301-734-60553010734601 VIAL in 1 CARTON (55301-734-60) / 20 LOZENGE in 1 VIALMarketed from Aug 14, 2018

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)
exchange select 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 203690
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 55301-734_2763a212-d5df-40a0-b50f-5870b9954a0dSPL ID 2763a212-d5df-40a0-b50f-5870b9954a0dSPL set ID e39e82a5-f642-4643-8509-4e585b8fa566RxCUI 359817UNII 6M3C89ZY6R
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

N455301073460 followed by a unit qualifier and the quantity

Package 55301-0734-60. 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 203690

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

FDA NDC Directory listings under ANDA 203690
ProductStrengthForm · routeLabelerProduct NDC
nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralKroger Company30142-797
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralKroger Company30142-696
up and up nicotine mini mintnicotine polacrilexNicotine 4 mg/1LozengeOralTarget Corporation82442-957
Nicotine PolacrilexNicotine 4 mg/1LozengeOralPadagis Israel Pharmaceuticals Ltd45802-957
basic care nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-642
Rexall Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralDolgencorp, LLC55910-957
Nicotine Mininicotine polacrilexNicotine 2 mg/1LozengeOralKroger Company30142-060
Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralMeijer Distribution Inc41250-734
Nicotine Mininicotine polacrilexNicotine 2 mg/1LozengeOralWalgreen Company0363-7051
mini nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralMeijer, Inc.79481-0734
nicotine mininicotine polacrilexNicotine 4 mg/1LozengeOralWalgreen Company0363-6011
Nicotine Mininicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-739
Basic Care Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-077
CareOne Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmerican Sales Company41520-734
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-734
Mini Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralMeijer, Inc.79481-0957
exchange select nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralArmy & Air Force Exchange Service55301-957
Equate Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWal-Mart Stores Inc49035-734
nicotine mininicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-797
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-808

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