Over-the-counter drug · ANDA
foster and thrive nicotine (nicotine polacrilex) NDC 70677-1164
Nicotine 2 mg/1 · Gum, Chewing · Oral · Strategic Sourcing Services LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70677-1164-1 | 70677116401 | 100 BLISTER PACK in 1 CARTON (70677-1164-1) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jun 19, 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 — 2 mg/1
- Dosage form
- Gum, Chewing
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078547
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 70677-1164_7079d131-81b0-43f5-81f2-c25c2efa3ae8SPL ID 7079d131-81b0-43f5-81f2-c25c2efa3ae8SPL set ID c5290759-84c0-4999-8222-d03a0b61bcd5RxCUI 314119UNII 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
N470677116401followed by a unit qualifier and the quantityPackage 70677-1164-01. 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 078547
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 2 mg/1 | Gum, ChewingOral | QUITINE LLC | 84720-352 |
| good sense nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-1352 |
| care one nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | American Sales Company | 41520-352 |
| Basic Care Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-352 |
| Equate nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Wal-Mart Stores Inc | 49035-352 |