Over-the-counter drug · ANDA

Nicorette (Nicotine polacrilex) NDC 0135-0635

Nicotine 2 mg/1 · Lozenge · Oral · Haleon US Holdings LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)0135-0635Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00135-0635Add 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
0135-0635-01001350635013 CONTAINER in 1 CARTON (0135-0635-01) / 72 LOZENGE in 1 CONTAINERMarketed from Jun 1, 2022

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)
Nicorette
Generic name (nonproprietary)
nicotine polacrilex
Active ingredients
Nicotine — 2 mg/1
Dosage form
Lozenge
Route
Oral
Labeler
Haleon US Holdings LLCNDC labeler code 0135
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077007
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 0135-0635_fd080df4-10ba-4b7e-a999-474f51610d2aSPL ID fd080df4-10ba-4b7e-a999-474f51610d2aSPL set ID ffeb8286-860d-49f5-8df3-724afb4aaad8RxCUI 359817, 359818, 968849, 968851UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400135063501 followed by a unit qualifier and the quantity

Package 00135-0635-01. 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 0135-0635

What is NDC 0135-0635?
0135-0635 is the product NDC for Nicorette (nicotine polacrilex), Nicotine 2 mg/1 lozenge, listed with the FDA by Haleon US Holdings LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nicorette (Nicotine polacrilex).
What is the active ingredient?
Nicotine.
Who is the labeler?
Haleon US Holdings LLC, NDC labeler code 0135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nicorette?
8 other product NDCs are listed under this name. See all Nicorette 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 Nicorette NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Nicorettenicotine polacrilexNicotine 4 mg/1LozengeOralHaleon US Holdings LLC0135-063600135-0636-01
Nicorettenicotine polacrilexNicotine 4 mg/1LozengeOralHaleon US Holdings LLC0135-150000135-1500-0100135-1500-02
Nicorettenicotine polacrilexNicotine 2 mg/1LozengeOralHaleon US Holdings LLC0135-280000135-2800-0100135-2800-02
Nicorettenicotine polacrilexNicotine 2 mg/1LozengeOralHaleon US Holdings LLC0135-062500135-0625-0100135-0625-0200135-0625-03
Nicorettenicotine polacrilexNicotine 4 mg/1LozengeOralHaleon US Holdings LLC0135-062600135-0626-0100135-0626-0200135-0626-03
Nicorettenicotine polacrilexNicotine 2 mg/1LozengeOralHaleon US Holdings LLC0135-051000135-0510-0100135-0510-0600135-0510-07
Nicorettenicotine polacrilexNicotine 4 mg/1LozengeOralHaleon US Holdings LLC0135-051100135-0511-0100135-0511-0600135-0511-07
Nicorettenicotine polacrilexNicotine 2 mg/1LozengeOralHaleon US Holdings LLC0135-050800135-0508-0200135-0508-0300135-0508-04

Other NDCs under ANDA 077007

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

FDA NDC Directory listings under ANDA 077007
ProductStrengthForm · routeLabelerProduct NDC
up and up mint nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralTarget Corporation82442-873
Equate Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWal-Mart Stores Inc49035-998
quitine nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralQUITINE LLC84720-007
berkley and jensen nicotine polacrilexnicotine polacrilexNicotine 4 mg/1LozengeOralBJWC68391-873
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-492
quitine nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralQUITINE LLC84720-000
Members Mark Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralSam's West Inc68196-873
Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWalgreen Company0363-2511
basic care nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-509
Quitine Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralQUITINE LLC84720-222
Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralRite Aid Corporation11822-1649
Quitine Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralQUITINE LLC84720-400
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralRite Aid Corporation11822-1720
Topcare Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralTopco Associates LLC76162-403
Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralHyVee Inc42507-344
Nicotine PolacrilexNicotine 4 mg/1LozengeOralPadagis Israel Pharmaceuticals Ltd45802-873
nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-651
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralSixarp, LLC59368-463
good sense nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralL. Perrigo Company0113-6305
exchange select nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralArmy & Air Force Exchange Service55301-617

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