Over-the-counter drug · ANDA

nicotine (Nicotine polacrilex) NDC 69842-605

Nicotine 2 mg/1 · Lozenge · Oral · CVS Pharmacy

NDC codes

FDA NDC Directory
Product NDC (as listed)69842-605Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69842-0605Add 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
69842-605-60698420605601 CONTAINER in 1 PACKAGE (69842-605-60) / 20 LOZENGE in 1 CONTAINERMarketed from Feb 4, 2020

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)
nicotine
Generic name (nonproprietary)
nicotine polacrilex
Active ingredients
Nicotine — 2 mg/1
Dosage form
Lozenge
Route
Oral
Labeler
CVS PharmacyNDC labeler code 69842
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203690
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 69842-605_259c3982-d30e-4dc8-b486-82b4546b9d60SPL ID 259c3982-d30e-4dc8-b486-82b4546b9d60SPL set ID 0837132a-a557-4e35-ad08-250b2c2fb644RxCUI 359817UNII 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

N469842060560 followed by a unit qualifier and the quantity

Package 69842-0605-60. 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 69842-605

What is NDC 69842-605?
69842-605 is the product NDC for nicotine (nicotine polacrilex), Nicotine 2 mg/1 lozenge, listed with the FDA by CVS Pharmacy. 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?
CVS Pharmacy, NDC labeler code 69842. 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?
194 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 LLC72288-73072288-0730-60
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
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralSixarp, LLC59368-46359368-0463-02

All 195 nicotine NDCs

Other NDCs under ANDA 203690

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

FDA NDC Directory listings under ANDA 203690
ProductStrengthForm · routeLabelerProduct NDC
Basic Care Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-077
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-223
basic care nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-642
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-734
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-808
basic care nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-957
berkley and jensen nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralBJWC68391-734
berkley and jensen nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralBJWC68391-957
Blipnicotine polacrilexNicotine 2 mg/1LozengeOralBlip Products, Inc.82966-222
Blipnicotine polacrilexNicotine 4 mg/1LozengeOralBlip Products, Inc.82966-303
Blipnicotine polacrilexNicotine 2 mg/1LozengeOralBlip Products, Inc.82966-734
Blipnicotine polacrilexNicotine 4 mg/1LozengeOralBlip Products, Inc.82966-957
CareOne Mini Nicotine Polacrilexnicotine polacrilexNicotine 4 mg/1LozengeOralAmerican Sales Company41520-957
CareOne Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmerican Sales Company41520-734
Dg Health Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralDolgencorp Inc55910-669
Equate Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWal-Mart Stores Inc49035-734
equate nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWal-Mart Stores Inc49035-791
Equate nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWal-Mart Stores Inc49035-900
equate nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWALMART INC.79903-104
equate nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWALMART INC.79903-160

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