Over-the-counter drug · ANDA

Nicotine (Nicotine polacrilex) NDC 0536-3113

Nicotine 4 mg/1 · Gum, Chewing · Buccal · Rugby Laboratories

NDC codes

FDA NDC Directory
Product NDC (as listed)0536-3113Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00536-3113Add 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
0536-3113-010053631130100536311301100 BLISTER PACK in 1 CARTON (0536-3113-01) / 1 GUM, CHEWING in 1 BLISTER PACK (0536-3113-25)Marketed from Dec 29, 2008
0536-3113-37005363113370053631133740 BLISTER PACK in 1 CARTON (0536-3113-37) / 1 GUM, CHEWING in 1 BLISTER PACK (0536-3113-25)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 — 4 mg/1
Dosage form
Gum, Chewing
Route
Buccal
Labeler
Rugby LaboratoriesNDC labeler code 0536
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078697
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 0536-3113_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

N400536311301 followed by a unit qualifier and the quantity

Package 00536-3113-01. 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)

About NDC 0536-3113

What is NDC 0536-3113?
0536-3113 is the product NDC for Nicotine (nicotine polacrilex), Nicotine 4 mg/1 gum, chewing, listed with the FDA by Rugby Laboratories. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nicotine (Nicotine Polacrilex).
What is the active ingredient?
Nicotine.
Who is the labeler?
Rugby Laboratories, NDC labeler code 0536. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nicotine?
197 other product NDCs are listed under this name. See all Nicotine NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Nicotine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralAmazon.com Services LLC72288-68472288-0684-02
Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmazon.com Services LLC72288-73072288-0730-60
nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmazon.com Services LLC72288-75572288-0755-06
Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmazon.com Services LLC72288-86372288-0863-06
Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralSafeway21130-77221130-0772-02
Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-96972288-0969-76
Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-86972288-0869-76
Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalCardinal Health 107, LLC55154-681855154-6818-00
nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-65172288-0651-14
Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWalgreen Company0363-251100363-2511-27

All 198 Nicotine NDCs

Other NDCs under ANDA 078697

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

FDA NDC Directory listings under ANDA 078697
ProductStrengthForm · routeLabelerProduct NDC
Habitrol Nicotine Polacrilex Gum 4 mg Coated Mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingOralDr. Reddy's Laboratories Inc.75907-303
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralWalgreens0363-9330
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralAmerisourceBergen (Good Neighbor Pharmacy) 4612246122-718
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralA-S Medication Solutions50090-8146
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingBuccalAAFES/Your Military Exchanges55301-429
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-796
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-976
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralRising Pharma Holdings, Inc.57237-323
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralLucy Goods, Inc.72224-933
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralQuitine LLC84720-933
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalPublix Supermarkets, Inc.56062-429
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalChain Drug Consortium, LLC68016-281
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalChain Drug Consortium, LLC68016-285
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalChain Drug Consortium, LLC68016-560
Nicotine Polacrilex coated mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalCVS Pharmacy69842-430
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalCARDINAL HEALTH 110, LLC. DBA LEADER 7000070000-0343

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