Over-the-counter drug · ANDA

Nicotine (nicotine polacrilex) NDC 0536-3112

Nicotine 2 mg/1 · Gum, Chewing · Buccal · Rugby Laboratories

NDC codes

FDA NDC Directory
Product NDC (as listed)0536-3112Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00536-3112Add 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
0536-3112-0100536311201100 BLISTER PACK in 1 CARTON (0536-3112-01) / 1 GUM, CHEWING in 1 BLISTER PACK (0536-3112-25)Marketed from Dec 29, 2008
0536-3112-370053631123740 BLISTER PACK in 1 CARTON (0536-3112-37) / 1 GUM, CHEWING in 1 BLISTER PACK (0536-3112-25)Marketed from Dec 29, 2008

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
Generic name (nonproprietary)
nicotine polacrilex
Active ingredients
Nicotine — 2 mg/1
Dosage form
Gum, Chewing
Route
Buccal
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078699
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 0536-3112_2ea2f7a2-3d30-4cd5-bc15-1181050f1d63SPL ID 2ea2f7a2-3d30-4cd5-bc15-1181050f1d63SPL set ID 621eb214-0716-4306-829f-6185a77f24d5RxCUI 311975, 314119UNII 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. Buccal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400536311201 followed by a unit qualifier and the quantity

Package 00536-3112-01. 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 078699

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

FDA NDC Directory listings under ANDA 078699
ProductStrengthForm · routeLabelerProduct NDC
Nicotine PolacrilexNicotine 2 mg/1Gum, ChewingOralAmerisourceBergen (Good Neighbor Pharmacy) 4612246122-717
Nicotine PolacrilexNicotine 2 mg/1Gum, ChewingOralRising Pharma Holdings, Inc.57237-322
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalCARDINAL HEALTH 110, LLC. DBA LEADER 7000070000-0347
Nicotine PolacrilexNicotine 2 mg/1Gum, ChewingOralQuitine LLC84720-927
Nicotine PolacrilexNicotine 2 mg/1Gum, ChewingBuccalAAFES/Your Military Exchanges55301-428
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalChain Drug Consortium, LLC68016-280
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalChain Drug Consortium, LLC68016-284
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalChain Drug Consortium, LLC68016-559
Nicotine Polacrilex coated mintnicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalCVS Pharmacy69842-428
Nicotine PolacrilexNicotine 2 mg/1Gum, ChewingOralWalgreens0363-9270
Nicotine PolacrilexNicotine 2 mg/1Gum, ChewingOralLucy Goods, Inc.72224-927
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalPublix Supermarkets, Inc.56062-428
Habitrol Nicotine Polacrilex Gum 2 mg Coated Mintnicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalDr. Reddy's Laboratories Inc.75907-302

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Nicotine (nicotine polacrilex) NDC 0536-3112 | Med-Code