NDC codes

FDA NDC Directory
Product NDC (as listed)0363-0262Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-0262Add 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
0363-0262-08003630262084 BOTTLE, PLASTIC in 1 BOX (0363-0262-08) / 27 LOZENGE in 1 BOTTLE, PLASTICMarketed from Aug 30, 2019
0363-0262-20003630262201 BOTTLE, PLASTIC in 1 BOX (0363-0262-20) / 20 LOZENGE in 1 BOTTLE, PLASTICMarketed from Aug 30, 2019
0363-0262-35003630262355 BOTTLE, PLASTIC in 1 BOX (0363-0262-35) / 27 LOZENGE in 1 BOTTLE, PLASTICMarketed from Aug 30, 2019
0363-0262-81003630262813 BOTTLE, PLASTIC in 1 BOTTLE (0363-0262-81) / 27 LOZENGE in 1 BOTTLE, PLASTICMarketed from Aug 30, 2019

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Nicotine Mini
Generic name (nonproprietary)
nicotine polacrilex
Active ingredients
Nicotine2 mg/1
Dosage form
Lozenge
Route
Oral
Labeler
Walgreens
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 0363-0262_53f29f90-3b59-47f4-b2ab-cde7f34a329dSPL ID 53f29f90-3b59-47f4-b2ab-cde7f34a329dSPL set ID 60551e9a-c82f-45ce-8ef4-03c00c6c870aRxCUI 359817UNII 6M3C89ZY6RUPC 0311917210070
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

N400363026208 followed by a unit qualifier and the quantity

Package 00363-0262-08. 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/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
Mini Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmerisourceBergen (Good Neighbor Pharmacy) 4612246122-716

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