Over-the-counter drug · ANDA
equate nicotine (nicotine polacrilex) NDC 49035-422
Nicotine 4 mg/1 · Gum, Chewing · Oral · Wal-Mart Stores Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49035-422-20 | 49035042220 | 200 BLISTER PACK in 1 CARTON (49035-422-20) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Aug 22, 2025 | |
| 49035-422-96 | 49035042296 | 170 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
- Labeler
- Wal-Mart Stores Inc
- 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
N449035042220followed by a unit qualifier and the quantityPackage 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.
Other NDCs under ANDA 078326
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Good Sensenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | A-S Medication Solutions | 50090-6240 |