Medline (nicotine) NDC 53329-191

NDC codes

FDA NDC Directory

Product NDC (as listed)53329-191Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53329-0191Add 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
53329-191-89	53329019189	14 POUCH in 1 CARTON (53329-191-89) / 1 PATCH in 1 POUCH (53329-191-09)Marketed from Aug 28, 2022

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): Medline
Generic name (nonproprietary): nicotine
Active ingredients: Nicotine — 14 mg/1
Dosage form: Patch
Route: Transdermal
Labeler: Medline Industries, LP
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074611
Marketing start: Jun 30, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Nicotine (Chemical structure)
Identifiers: Product ID 53329-191_42c99420-c566-55f4-e063-6294a90ad873SPL ID 42c99420-c566-55f4-e063-6294a90ad873SPL set ID e11a4b7e-6f1f-24db-e053-2a95a90a0d09RxCUI 198029, 198030, 198031UNII 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. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N453329019189 followed by a unit qualifier and the quantity

Package 53329-0191-89. 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 Nov 4, 2025.

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)