Over-the-counter drug · ANDA

berkley and jensen nicotine (Nicotine polacrilex) NDC 68391-344

Nicotine 2 mg/1 · Lozenge · Oral · BJWC

NDC codes

FDA NDC Directory
Product NDC (as listed)68391-344Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68391-0344Add 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
68391-344-13683910344137 CONTAINER in 1 CARTON (68391-344-13) / 27 LOZENGE in 1 CONTAINER (68391-344-00)Marketed from Aug 26, 2016

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)
berkley and jensen nicotine
Generic name (nonproprietary)
nicotine polacrilex
Active ingredients
Nicotine — 2 mg/1
Dosage form
Lozenge
Route
Oral
Labeler
BJWCNDC labeler code 68391
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 68391-344_97ae25d7-fae4-4a6b-a3ca-7585d1072cdfSPL ID 97ae25d7-fae4-4a6b-a3ca-7585d1072cdfSPL set ID 3a408d89-974f-4a20-aee9-fb1fe0a7ef3eRxCUI 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

N468391034413 followed by a unit qualifier and the quantity

Package 68391-0344-13. 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 68391-344

What is NDC 68391-344?
68391-344 is the product NDC for berkley and jensen nicotine (nicotine polacrilex), Nicotine 2 mg/1 lozenge, listed with the FDA by BJWC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
berkley and jensen nicotine (Nicotine Polacrilex).
What is the active ingredient?
Nicotine.
Who is the labeler?
BJWC, NDC labeler code 68391. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for berkley and jensen nicotine?
6 other product NDCs are listed under this name. See all berkley and jensen 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 berkley and jensen nicotine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
berkley and jensen nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralBJWC68391-73468391-0734-06
berkley and jensen nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralBJWC68391-95768391-0957-0168391-0957-06
Berkley and Jensen NICOTINEnicotine polacrilexNicotine 2 mg/1Gum, ChewingOralBJWC68391-01268391-0012-70
Berkley and Jensen Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralBJWC68391-30968391-0309-70
berkley and jensen nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralBJWC68391-02968391-0029-0668391-0029-36
berkley and jensen nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralBJWC68391-17068391-0170-36

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
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-344
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-492
basic care nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-509
basic care nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-873
berkley and jensen nicotine polacrilexnicotine polacrilexNicotine 4 mg/1LozengeOralBJWC68391-873
care one nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmerican Sales Company41520-873
careone nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmerican Sales Company41520-701
equate nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWal-Mart Stores Inc49035-873
Equate Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWal-Mart Stores Inc49035-998
equate nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWALMART INC.79903-182
Equate Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWALMART INC.79903-353
Equate Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWALMART INC.79903-354
euqate nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWALMART INC.79903-101
exchange select nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralArmy & Air Force Exchange Service55301-617
exchange select nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralArmy & Air Force Exchange Service55301-873
foster and thrive nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralStrategic Sourcing Services LLC70677-1176
foster and thrive nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralStrategic Sourcing Services LLC70677-1177
Good Sense Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralL. Perrigo Company0113-0344
good sense nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralL. Perrigo Company0113-0873
Good Sense Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralL. Perrigo Company0113-2502

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