Over-the-counter drug · ANDA
members mark nicotine (nicotine polacrilex) NDC 68196-170
Nicotine 4 mg/1 · Gum, Chewing · Oral · Sam's West Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68196-170-01 | 68196017001 | 2 CARTON in 1 PACKAGE (68196-170-01) / 190 BLISTER PACK in 1 CARTON (68196-170-56) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Apr 18, 2019 | |
| 68196-170-38 | 68196017038 | 380 BLISTER PACK in 1 CARTON (68196-170-38) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Sep 11, 2025 |
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)
- members mark nicotine
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Gum, Chewing
- Route
- Oral
- Labeler
- Sam's West Inc
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076789
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 68196-170_5e836db2-00e1-4bd4-9f3d-b1b70761ba1aSPL ID 5e836db2-00e1-4bd4-9f3d-b1b70761ba1aSPL set ID 8edad777-6491-4ab2-9835-709bf54d5f0cRxCUI 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
N468196017001followed by a unit qualifier and the quantityPackage 68196-0170-01. 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 .
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.