NDC codes

FDA NDC Directory
Product NDC (as listed)46122-733Labeler and product segments. Claims need a package NDC.
Product NDC at billing width46122-0733Add 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
46122-733-604612207336020 BLISTER PACK in 1 CARTON (46122-733-60) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Sep 30, 2022

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)
Nicotine
Generic name (nonproprietary)
nicotine polacrilex
Active ingredients
Nicotine — 4 mg/1
Dosage form
Gum, Chewing
Route
Oral
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 46122-733_96dc8684-d49d-435b-9bef-beeb547eab8fSPL ID 96dc8684-d49d-435b-9bef-beeb547eab8fSPL set ID 6432c7fc-02d3-42a4-bd46-d48250a1d4d2RxCUI 311975UNII 6M3C89ZY6RUPC 0346122733601
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

N446122073360 followed by a unit qualifier and the quantity

Package 46122-0733-60. 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 074707

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

FDA NDC Directory listings under ANDA 074707
ProductStrengthForm · routeLabelerProduct NDC
Rugby Nicotine Polacrilex Gum, Original Flavornicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalATLANTIC BIOLOGICALS CORP.17856-3030
Nicotine Polacrilex, Originalnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalChain Drug Consortium, LLC68016-287
Nicotine Polacrilex originalnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalWalgreens0363-1609
Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalRugby Laboratories0536-3030
Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralWalgreens0363-9350
Nicotine Polacrilex Origianl Flavornicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalPublix Supermarkets, Inc.56062-609
Nicotine Polacrilex originalnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalCVS Pharmacy69842-609
Nicotine Polacrilex Originalnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalCARDINAL HEALTH 110, LLC. DBA LEADER 7000070000-0341
Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralP & L Development, LLC59726-935
Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralThe Kroger Co.30142-671

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