NDC codes

FDA NDC Directory
Product NDC (as listed)69842-608Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69842-0608Add 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
69842-608-156984206081520 BLISTER PACK in 1 CARTON (69842-608-15) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 1, 2014
69842-608-506984206085050 BLISTER PACK in 1 CARTON (69842-608-50) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 1, 2014
69842-608-796984206087910 BLISTER PACK in 1 CARTON (69842-608-79) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 1, 2014
69842-608-9869842060898170 BLISTER PACK in 1 CARTON (69842-608-98) / 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 originalSuffix: original
Generic name (nonproprietary)
nicotine polacrilex
Active ingredients
Nicotine — 2 mg/1
Dosage form
Gum, Chewing
Route
Buccal
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074507
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 69842-608_0ab21cfd-645a-4c3a-b497-f77099ed1c9fSPL ID 0ab21cfd-645a-4c3a-b497-f77099ed1c9fSPL set ID 62231539-ae9f-4665-ba59-bef047e93d8aRxCUI 311975, 314119UNII 6M3C89ZY6RUPC 0050428335727, 0050428373798
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

N469842060815 followed by a unit qualifier and the quantity

Package 69842-0608-15. 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)

Other NDCs under ANDA 074507

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

FDA NDC Directory listings under ANDA 074507
ProductStrengthForm · routeLabelerProduct NDC
Nicotine Polacrilex, Originalnicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalChain Drug Consortium, LLC68016-286
Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralThe Kroger Co.30142-859
Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralMcKesson Corporation dba SKY Packaging63739-371
Nicotine Polacrilex originalnicotine polacrilexNicotine 2 mg/1Gum, ChewingOralWalgreens0363-1608
Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralWalgreens0363-9290
Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalRugby Laboratories0536-3029
Nicotine Polacrilex Original Flavornicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalPublix Supermarkets, Inc.56062-608
Nicotine Polacrilex Originalnicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalCARDINAL HEALTH 110, LLC. DBA LEADER 7000070000-0345
Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralP & L Development, LLC59726-929
Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralAmerisourceBergen (Good Neighbor Pharmacy) 4612246122-719

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