Over-the-counter drug · ANDA

basic care nicotine (Nicotine polacrilex) NDC 72288-509

Nicotine 4 mg/1 · Lozenge · Oral · Amazon.com Services LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)72288-509Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72288-0509Add 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
72288-509-587228805095840 LOZENGE in 1 CONTAINER (72288-509-58)Marketed from Jul 20, 2023
72288-509-76722880509763 CONTAINER in 1 CARTON (72288-509-76) / 40 LOZENGE in 1 CONTAINERMarketed from Jul 20, 2023

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)
basic care nicotine
Generic name (nonproprietary)
nicotine polacrilex
Active ingredients
Nicotine — 4 mg/1
Dosage form
Lozenge
Route
Oral
Labeler
Amazon.com Services LLCNDC labeler code 72288
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 72288-509_9582d831-2347-465c-af54-99ce27f4effbSPL ID 9582d831-2347-465c-af54-99ce27f4effbSPL set ID d6566f92-cf41-4032-a66b-3d1cdf661f33RxCUI 359818UNII 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

N472288050958 followed by a unit qualifier and the quantity

Package 72288-0509-58. 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 72288-509

What is NDC 72288-509?
72288-509 is the product NDC for basic care nicotine (nicotine polacrilex), Nicotine 4 mg/1 lozenge, listed with the FDA by Amazon.com Services LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
basic care nicotine (Nicotine polacrilex).
What is the active ingredient?
Nicotine.
Who is the labeler?
Amazon.com Services LLC, NDC labeler code 72288. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for basic care nicotine?
22 other product NDCs are listed under this name. See all basic care 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 basic care nicotine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
basic care nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmazon.com Services LLC72288-69372288-0693-0172288-0693-29
basic care nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmazon.com Services LLC72288-57772288-0577-0672288-0577-60
basic care nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralAmazon.com Services LLC72288-81172288-0811-0172288-0811-29
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-49272288-0492-76
Basic Care Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-07772288-0077-0972288-0077-14
Basic Care Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralAmazon.com Services LLC72288-29272288-0292-0672288-0292-60
Basic Care Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-19072288-0190-0572288-0190-11
basic care nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-95772288-0957-0172288-0957-0472288-0957-07
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-80872288-0808-0972288-0808-14
Basic Care Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmazon.com Services LLC72288-00372288-0003-0672288-0003-60

All 23 basic care nicotine NDCs

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
Good Sense Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralL. Perrigo Company0113-0344
nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralPublix Super Markets Inc56062-671
equate nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWal-Mart Stores Inc49035-873
Good Sense Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralL. Perrigo Company0113-5023
quitine nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralQUITINE LLC84720-000
foster and thrive nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralStrategic Sourcing Services LLC70677-1177
nicotine lozengenicotine polacrilexNicotine 2 mg/1LozengeOralH E B37808-674
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralCVS Pharmacy69842-587
foster and thrive nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralStrategic Sourcing Services LLC70677-1176
up and up nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralTarget Corporation82442-741
quitine nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralQUITINE LLC84720-007
Nicotine PolacrilexNicotine 2 mg/1LozengeOralPadagis Israel Pharmaceuticals Ltd45802-344
Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralCVS Pharmacy69842-595
Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-969
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-344
nicotine coatednicotine polacrilexNicotine 2 mg/1LozengeOralPublix Super Markets Inc56062-543
Quitine Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralQUITINE LLC84720-222
Quitine Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralQUITINE LLC84720-400
up and up mint nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralTarget Corporation82442-873
Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralPublix Super Markets Inc56062-636

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