Over-the-counter drug · ANDA

nicotine (Nicotine polacrilex) NDC 79481-1100

Nicotine 4 mg/1 · Lozenge · Oral · Meijer, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)79481-1100Labeler and product segments. Claims need a package NDC.
Product NDC at billing width79481-1100Add 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
79481-1100-0794811100001 CONTAINER in 1 CARTON (79481-1100-0) / 20 LOZENGE in 1 CONTAINERMarketed from Sep 6, 2023
79481-1100-1794811100012 CONTAINER in 1 CARTON (79481-1100-1) / 40 LOZENGE in 1 CONTAINER (79481-1100-2)Marketed from Aug 23, 2023

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 — 4 mg/1
Dosage form
Lozenge
Route
Oral
Labeler
Meijer, Inc.NDC labeler code 79481
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 79481-1100_7ecd9a6a-1237-4375-b72c-9f2e30557650SPL ID 7ecd9a6a-1237-4375-b72c-9f2e30557650SPL set ID aee78555-7851-46a5-b9fa-c98b46354619RxCUI 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

N479481110000 followed by a unit qualifier and the quantity

Package 79481-1100-00. 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 79481-1100

What is NDC 79481-1100?
79481-1100 is the product NDC for nicotine (nicotine polacrilex), Nicotine 4 mg/1 lozenge, listed with the FDA by Meijer, Inc.. 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?
Meijer, Inc., NDC labeler code 79481. 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?
196 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 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
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralSixarp, LLC59368-46359368-0463-02
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-88872288-0888-14

All 197 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

Showing 20 of 39.

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