NDC codes

FDA NDC Directory
Product NDC (as listed)46122-716Labeler and product segments. Claims need a package NDC.
Product NDC at billing width46122-0716Add 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
46122-716-15461220716153 BOTTLE, PLASTIC in 1 BOX (46122-716-15) / 27 LOZENGE in 1 BOTTLE, PLASTICMarketed from Feb 8, 2023
46122-716-16461220716161 BOTTLE, PLASTIC in 1 BOX (46122-716-16) / 27 LOZENGE in 1 BOTTLE, PLASTICMarketed from Feb 8, 2023
46122-716-60461220716601 BOTTLE, PLASTIC in 1 BOX (46122-716-60) / 20 LOZENGE in 1 BOTTLE, PLASTICMarketed from Feb 22, 2023

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)
Mini Nicotine
Generic name (nonproprietary)
nicotine polacrilex
Active ingredients
Nicotine — 4 mg/1
Dosage form
Lozenge
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207868
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 46122-716_7100dc63-397a-4caf-80c3-c43e0e5f0054SPL ID 7100dc63-397a-4caf-80c3-c43e0e5f0054SPL set ID 7f1cdc21-d213-4ede-86fd-e11b31dfab58RxCUI 359818UNII 6M3C89ZY6RUPC 0087701434785
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

N446122071615 followed by a unit qualifier and the quantity

Package 46122-0716-15. 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 207868

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

FDA NDC Directory listings under ANDA 207868
ProductStrengthForm · routeLabelerProduct NDC
Mini Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralATLANTIC BIOLOGICALS CORP.17856-1241
Nicotine Mininicotine polacrilexNicotine 2 mg/1LozengeOralRite Aid Corporation11822-3315
Nicotine Mininicotine polacrilexNicotine 2 mg/1LozengeOralWalgreens0363-0262
Nicotine Mininicotine polacrilexNicotine 2 mg/1LozengeOralRugby Laboratories, Inc.0536-1239
Mini Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralRugby Laboratories, Inc.0536-1241
Nicotine Mininicotine polacrilexNicotine 4 mg/1LozengeOralCardinal Health (Leader) 7000070000-0559
Nicotine Mininicotine polacrilexNicotine 2 mg/1LozengeOralCardinal Health (Leader) 7000070000-0560
Mini Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-662
Mini Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralHC Jones, Inc.83253-264
Nicotine Mininicotine polacrilexNicotine 2 mg/1LozengeOralHC Jones, Inc.83253-262
Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralCVS Pharmacy69842-564
Nicotine Mininicotine polacrilexNicotine 2 mg/1LozengeOralWALMART INC. (see also Equate)79903-127
Mini Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWALMART INC. (see also Equate)79903-128
Nicotine Mininicotine polacrilexNicotine 2 mg/1LozengeOralP & L Development, LLC59726-262
Mini Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWalgreens0363-2640
Mini Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralP & L Development, LLC59726-264
Nicotine Mininicotine polacrilexNicotine 4 mg/1LozengeOralPLD Acquisitions LLC DBA Avma Pharma Solutions63548-0264
Nicotine Sugar Freenicotine polacrilexNicotine 2 mg/1LozengeOralCVS Pharmacy69842-662
Nicotine Mininicotine polacrilexNicotine 2 mg/1LozengeOralPLD Acquisitions LLC DBA Avma Pharma Solutions63548-0262
Mini Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)49035-436

Showing 20 of 27.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in