Over-the-counter drug · ANDA
foster and thrive nicotine (nicotine polacrilex) NDC 70677-1165
Nicotine 4 mg/1 · Gum, Chewing · Oral · Strategic Sourcing Services LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70677-1165-1 | 70677116501 | 100 BLISTER PACK in 1 CARTON (70677-1165-1) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jun 27, 2024 |
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)
- foster and thrive 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 078546
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 70677-1165_15d66215-012f-4e93-9006-5310e6fdd52fSPL ID 15d66215-012f-4e93-9006-5310e6fdd52fSPL set ID 0f1b3cc6-98df-4e34-91f3-dc251fe170f8RxCUI 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
N470677116501followed by a unit qualifier and the quantityPackage 70677-1165-01. 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.
Other NDCs under ANDA 078546
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 |
|---|---|---|---|---|
| quitine nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | QUITINE LLC | 84720-854 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Meijer Distribution Inc | 41250-854 |
| Care One Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | American Sales Company | 41520-854 |
| Equate Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Wal-Mart Stores Inc | 49035-854 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-0854 |