Over-the-counter drug · ANDA

Good Sense Nicotine (Nicotine polacrilex) NDC 0113-0344

Nicotine 2 mg/1 · Lozenge · Oral · L. Perrigo Company

NDC codes

FDA NDC Directory
Product NDC (as listed)0113-0344Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00113-0344Add 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
0113-0344-05001130344053 CONTAINER in 1 CARTON (0113-0344-05) / 24 LOZENGE in 1 CONTAINERMarketed from Nov 28, 2009
0113-0344-14001130344148 CONTAINER in 1 CARTON (0113-0344-14) / 27 LOZENGE in 1 CONTAINER (0113-0344-09)Marketed from Jun 18, 2024
0113-0344-16001130344166 CONTAINER in 1 CARTON (0113-0344-16) / 24 LOZENGE in 1 CONTAINER (0113-0344-03)Marketed from Jun 18, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Good Sense Nicotine
Generic name (nonproprietary)
nicotine polacrilex
Active ingredients
Nicotine — 2 mg/1
Dosage form
Lozenge
Route
Oral
Labeler
L. Perrigo CompanyNDC labeler code 0113
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 0113-0344_425412f0-cd0b-4f06-b76c-99d525e613a5SPL ID 425412f0-cd0b-4f06-b76c-99d525e613a5SPL set ID c505dde1-2647-4c7b-99f5-9865e7c78e43RxCUI 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

N400113034405 followed by a unit qualifier and the quantity

Package 00113-0344-05. 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 0113-0344

What is NDC 0113-0344?
0113-0344 is the product NDC for Good Sense Nicotine (nicotine polacrilex), Nicotine 2 mg/1 lozenge, listed with the FDA by L. Perrigo Company. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Good Sense Nicotine (Nicotine Polacrilex).
What is the active ingredient?
Nicotine.
Who is the labeler?
L. Perrigo Company, NDC labeler code 0113. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Good Sense Nicotine?
27 other product NDCs are listed under this name. See all Good Sense 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 Good Sense Nicotine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
good sense nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralL. Perrigo Company0113-630500113-6305-60
Good Sense Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralL. Perrigo Company0113-796900113-7969-01
good sense nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralL. Perrigo Company0113-799900113-7999-60
Good Sense Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralL. Perrigo Company0113-411100113-4111-06
Good Sense Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralL. Perrigo Company0113-602000113-6020-0600113-6020-60
Good Sense Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralL. Perrigo Company0113-702000113-7020-14
Good Sense Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralL. Perrigo Company0113-703100113-7031-14
Good Sense Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralL. Perrigo Company0113-502300113-5023-2700113-5023-6000113-5023-76
Good Sense Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralL. Perrigo Company0113-250200113-2502-2700113-2502-6000113-2502-76
good sense nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralL. Perrigo Company0113-860000113-8600-0100113-8600-2500113-8600-29

All 28 Good Sense 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
up and up mint nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralTarget Corporation82442-873
Equate Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWal-Mart Stores Inc49035-998
quitine nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralQUITINE LLC84720-007
berkley and jensen nicotine polacrilexnicotine polacrilexNicotine 4 mg/1LozengeOralBJWC68391-873
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-492
quitine nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralQUITINE LLC84720-000
Members Mark Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralSam's West Inc68196-873
Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWalgreen Company0363-2511
basic care nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-509
Quitine Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralQUITINE LLC84720-222
Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralRite Aid Corporation11822-1649
Quitine Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralQUITINE LLC84720-400
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralRite Aid Corporation11822-1720
Topcare Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralTopco Associates LLC76162-403
Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralHyVee Inc42507-344
Nicotine PolacrilexNicotine 4 mg/1LozengeOralPadagis Israel Pharmaceuticals Ltd45802-873
nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-651
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralSixarp, LLC59368-463
good sense nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralL. Perrigo Company0113-6305
exchange select nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralArmy & Air Force Exchange Service55301-617

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