Over-the-counter drug · ANDA
Nicotine Polacrilex Coated Ice Mint (Nicotine polacrilex) NDC 70000-0348
Nicotine 2 mg/1 · Gum, Chewing · Buccal · CARDINAL HEALTH 110, LLC. DBA LEADER 70000
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0348-1 | 70000034801 | 20 BLISTER PACK in 1 CARTON (70000-0348-1) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jul 3, 2018 | |
| 70000-0348-2 | 70000034802 | 100 BLISTER PACK in 1 CARTON (70000-0348-2) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jul 3, 2018 |
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)
- Nicotine Polacrilex Coated Ice MintSuffix: Coated Ice Mint
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 2 mg/1
- Dosage form
- Gum, Chewing
- Route
- Buccal
- Labeler
- CARDINAL HEALTH 110, LLC. DBA LEADER 70000NDC labeler code 70000
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204794
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 70000-0348_995f5f15-e607-4cca-85e3-ec8942812bceSPL ID 995f5f15-e607-4cca-85e3-ec8942812bceSPL set ID b075c3cb-d610-4a9c-8cf0-e4b9001bc86aRxCUI 311975, 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. Buccal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470000034801followed by a unit qualifier and the quantityPackage 70000-0348-01. 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.
About NDC 70000-0348
- What is NDC 70000-0348?
- 70000-0348 is the product NDC for Nicotine Polacrilex Coated Ice Mint, Nicotine 2 mg/1 gum, chewing, listed with the FDA by CARDINAL HEALTH 110, LLC. DBA LEADER 70000. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nicotine Polacrilex Coated Ice Mint (Nicotine Polacrilex).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- CARDINAL HEALTH 110, LLC. DBA LEADER 70000, NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nicotine Polacrilex Coated Ice Mint?
- 5 other product NDCs are listed under this name. See all Nicotine Polacrilex Coated Ice Mint NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nicotine Polacrilex Coated Ice Mint products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nicotine Polacrilex Coated Ice Mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 70000-0344 | 70000-0344-0170000-0344-02 |
| Nicotine Polacrilex coated ice mintnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-448 | 46122-0448-58 |
| Nicotine Polacrilex coated ice mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-449 | 46122-0449-58 |
| Nicotine Polacrilex coated ice mintnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | CVS Pharmacy | 69842-216 | 69842-0216-1569842-0216-1669842-0216-44 |
| Nicotine Polacrilex coated ice mintnicotine polacrilex gum | Nicotine 4 mg/1 | Gum, ChewingBuccal | CVS Pharmacy | 69842-217 | 69842-0217-1569842-0217-1669842-0217-44 |
Other NDCs under ANDA 204794
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 |
|---|---|---|---|---|
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Walgreens | 0363-9260 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Chain Drug Consortium, LLC | 68016-292 |
| Nicotine Polacrilex coated ice mintnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-448 |
| Nicotine Polacrilex coated ice mintnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | CVS Pharmacy | 69842-216 |