NDC codes

FDA NDC Directory
Product NDC (as listed)55301-429Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55301-0429Add 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
55301-429-445530104294455301042944100 BLISTER PACK in 1 CARTON (55301-429-44) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 1, 2014

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
Buccal
Labeler
AAFES/Your Military ExchangesNDC labeler code 55301
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078697
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 55301-429_34a618ae-4046-daa4-e063-6394a90a9fd2SPL ID 34a618ae-4046-daa4-e063-6394a90a9fd2SPL set ID 27308f6b-43b9-4b1d-af6b-7a39b79def03RxCUI 311975, 314119UNII 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. Buccal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N455301042944 followed by a unit qualifier and the quantity

Package 55301-0429-44. 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 55301-429

What is NDC 55301-429?
55301-429 is the product NDC for Nicotine Polacrilex, Nicotine 4 mg/1 gum, chewing, listed with the FDA by AAFES/Your Military Exchanges. 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?
AAFES/Your Military Exchanges, NDC labeler code 55301. 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 078697

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

FDA NDC Directory listings under ANDA 078697
ProductStrengthForm · routeLabelerProduct NDC
Habitrol Nicotine Polacrilex Gum 4 mg Coated Mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingOralDr. Reddy's Laboratories Inc.75907-303
Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalRugby Laboratories0536-3113
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralWalgreens0363-9330
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralAmerisourceBergen (Good Neighbor Pharmacy) 4612246122-718
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralA-S Medication Solutions50090-8146
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-796
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-976
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralRising Pharma Holdings, Inc.57237-323
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralLucy Goods, Inc.72224-933
Nicotine PolacrilexNicotine 4 mg/1Gum, ChewingOralQuitine LLC84720-933
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalPublix Supermarkets, Inc.56062-429
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalChain Drug Consortium, LLC68016-281
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalChain Drug Consortium, LLC68016-285
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalChain Drug Consortium, LLC68016-560
Nicotine Polacrilex coated mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalCVS Pharmacy69842-430
Nicotine Polacrilex Coated Mintnicotine polacrilexNicotine 4 mg/1Gum, ChewingBuccalCARDINAL HEALTH 110, LLC. DBA LEADER 7000070000-0343

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in