NDC codes

FDA NDC Directory
Product NDC (as listed)55319-966Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55319-0966Add 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
55319-966-20553190966205531909662020 BLISTER PACK in 1 CARTON (55319-966-20) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jul 1, 2023

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 Polacrilex
Generic name (nonproprietary)
nicotine polacrilex
Active ingredients
Nicotine — 4 mg/1
Dosage form
Gum, Chewing
Route
Oral
Labeler
Family Dollar (FAMILY WELLNESS)NDC labeler code 55319
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204833
Marketing start
Marketing end
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 55319-966_f4825c27-4253-4314-aa55-4d9819030f30SPL ID f4825c27-4253-4314-aa55-4d9819030f30SPL set ID d353b75f-3fc3-4958-92c6-08df6bdf283cRxCUI 311975UNII 6M3C89ZY6RUPC 0032251921056
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

N455319096620 followed by a unit qualifier and the quantity

Package 55319-0966-20. 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 55319-966

What is NDC 55319-966?
55319-966 is the product NDC for Nicotine Polacrilex, Nicotine 4 mg/1 gum, chewing, listed with the FDA by Family Dollar (FAMILY WELLNESS). It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nicotine Polacrilex.
What is the active ingredient?
Nicotine.
Who is the labeler?
Family Dollar (FAMILY WELLNESS), NDC labeler code 55319. 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 Polacrilex?
48 other product NDCs are listed under this name. See all Nicotine Polacrilex 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 Polacrilex NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Nicotine PolacrilexNicotine 2 mg/1Gum, ChewingOralLucy Goods, Inc.72224-92772224-0927-10
Nicotine PolacrilexNicotine 2 mg/1Gum, ChewingOralLucy Goods, Inc.72224-92472224-0924-10
Nicotine PolacrilexNicotine 2 mg/1Gum, ChewingOralLucy Goods, Inc.72224-92572224-0925-10
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralLucy Goods, Inc.72224-93372224-0933-10
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-97655910-0976-20
Nicotine PolacrilexNicotine 2 mg/1Gum, ChewingOralQuitine LLC84720-92784720-0927-03
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralQuitine LLC84720-93384720-0933-03
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-79655910-0796-20
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-93355910-0933-10
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralA-S Medication Solutions50090-814650090-8146-00

All 49 Nicotine Polacrilex NDCs

Other NDCs under ANDA 204833

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

FDA NDC Directory listings under ANDA 204833
ProductStrengthForm · routeLabelerProduct NDC
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralWalgreens0363-3290
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-933
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingBuccalChain Drug Consortium, LLC68016-293
Nicotine Polacrilex coated ice mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalAmerisourceBergen (Good Neighbor Pharmacy) 4612246122-449
Nicotine Polacrilex coated ice mintnicotine polacrilex gumNicotine 4 mg/1Gum, ChewingBuccalCVS Pharmacy69842-217
Nicotine Polacrilex Coated Ice Mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalCARDINAL HEALTH 110, LLC. DBA LEADER 7000070000-0344

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