What is NDC 63443-5057?

63443-5057 is the product NDC for Nicotine Polacrilex Gum (nicotine polacrilex), Nicotine 4 mg/1 gum, chewing, listed with the FDA by Fertin Pharma A/S. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Nicotine Polacrilex Gum (Nicotine Polacrilex).

Fertin Pharma A/S, NDC labeler code 63443. 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 Gum?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nicotine Polacrilex Gum NDC 63443-5057

NDC codes

FDA NDC Directory

Product NDC (as listed)63443-5057Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63443-5057Add 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 NDC	11-digit (billing)	Package	Copy
63443-5057-1	63443505701	10 BLISTER PACK in 1 CARTON (63443-5057-1) / 10 GUM, CHEWING in 1 BLISTER PACKMarketed from Dec 21, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 Gum
Generic name (nonproprietary): nicotine polacrilex
Active ingredients: Nicotine — 4 mg/1
Dosage form: Gum, Chewing
Route: Buccal
Labeler: Fertin Pharma A/SNDC labeler code 63443
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214354
Marketing start: Dec 21, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Nicotine (Chemical structure)
Identifiers: Product ID 63443-5057_4b1e2904-b22d-4cb9-e063-6294a90a532cSPL ID 4b1e2904-b22d-4cb9-e063-6294a90a532cSPL set ID f1774540-7c2f-c60b-e053-2995a90a1ccbRxCUI 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. Buccal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N463443505701 followed by a unit qualifier and the quantity

Package 63443-5057-01. 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 Feb 18, 2026.

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 63443-5057

What is NDC 63443-5057?: 63443-5057 is the product NDC for Nicotine Polacrilex Gum (nicotine polacrilex), Nicotine 4 mg/1 gum, chewing, listed with the FDA by Fertin Pharma A/S. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nicotine Polacrilex Gum (Nicotine Polacrilex).
What is the active ingredient?: Nicotine.
Who is the labeler?: Fertin Pharma A/S, NDC labeler code 63443. 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 Gum?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Nicotine Polacrilex Gum (Nicotine polacrilex) NDC 63443-5057