NDC codes

FDA NDC Directory
Product NDC (as listed)49035-422Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49035-0422Add 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
49035-422-2049035042220200 BLISTER PACK in 1 CARTON (49035-422-20) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Aug 22, 2025
49035-422-9649035042296170 BLISTER PACK in 1 CARTON (49035-422-96) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Apr 6, 2005

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)
equate nicotine
Generic name (nonproprietary)
nicotine polacrilex
Active ingredients
Nicotine — 4 mg/1
Dosage form
Gum, Chewing
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078326
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 49035-422_a2d76866-1ccb-46cf-b85a-974a4b407303SPL ID a2d76866-1ccb-46cf-b85a-974a4b407303SPL set ID 768e3f3d-d867-4574-8a5d-07572e2e4a04RxCUI 311975UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N449035042220 followed by a unit qualifier and the quantity

Package 49035-0422-20. 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)

Other NDCs under ANDA 078326

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

FDA NDC Directory listings under ANDA 078326
ProductStrengthForm · routeLabelerProduct NDC
Good Sensenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralA-S Medication Solutions50090-6240

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