Over-the-counter drug · ANDA

nicotine (Nicotine polacrilex) NDC 11822-0124

Nicotine 2 mg/1 · Lozenge · Oral · Rite Aid Corporation

NDC codes

FDA NDC Directory
Product NDC (as listed)11822-0124Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11822-0124Add 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
11822-0124-111822012401118220124013 CONTAINER in 1 CARTON (11822-0124-1) / 24 LOZENGE in 1 CONTAINERMarketed from Feb 5, 2015

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Lozenge
Route
Oral
Labeler
Rite Aid CorporationNDC labeler code 11822
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090711
Marketing start
Marketing end
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 11822-0124_fdc04364-11ec-4f68-b844-5d9df23aec2bSPL ID fdc04364-11ec-4f68-b844-5d9df23aec2bSPL set ID 6020abb5-2a4f-4602-8014-e2b4e462c05fRxCUI 359817UNII 6M3C89ZY6RUPC 0012345678905
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

N411822012401 followed by a unit qualifier and the quantity

Package 11822-0124-01. 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 11822-0124

What is NDC 11822-0124?
11822-0124 is the product NDC for nicotine (nicotine polacrilex), Nicotine 2 mg/1 lozenge, listed with the FDA by Rite Aid Corporation. It has 1 package NDC, 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?
Rite Aid Corporation, NDC labeler code 11822. 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 090711

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

FDA NDC Directory listings under ANDA 090711
ProductStrengthForm · routeLabelerProduct NDC
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-124
Basic Care Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-190
equate nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWal-Mart Stores Inc49035-124
Equate Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWal-Mart Stores Inc49035-190
Good Sense Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralL. Perrigo Company0113-1125
good sense nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralL. Perrigo Company0113-1190
Kirkland Signature NicotinenicotineNicotine 2 mg/1LozengeOralCostco Wholesale Company63981-124
Kirkland Signature NicotinenicotineNicotine 4 mg/1LozengeOralCostco Wholesale Company63981-190
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWalgreen Company0363-0124
Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWalgreen Company0363-4190
nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralRite Aid Corporation11822-0009
Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralKroger Company30142-124
Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralKroger Company30142-190
nicotineNicotine 4 mg/1LozengeOralH E B37808-383
nicotineNicotine 2 mg/1LozengeOralH E B37808-533
nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralMeijer Distribution Inc41250-190
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralMeijer Distribution Inc41250-700
Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-190
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralPublix Super Markets Inc56062-499
nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralPublix Super Markets Inc56062-509

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