Over-the-counter drug · ANDA
Maxi Nicotine (Nicotine polacrilex) NDC 70000-0561
Nicotine 4 mg/1 · Lozenge · Oral · Cardinal Health (Leader) 70000
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0561-1 | 7000005610170000056101 | 3 BOTTLE, PLASTIC in 1 BOX (70000-0561-1) / 24 LOZENGE in 1 BOTTLE, PLASTICMarketed from Jul 1, 2020 |
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)
- Maxi Nicotine
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Lozenge
- Route
- Oral
- Labeler
- Cardinal Health (Leader) 70000NDC labeler code 70000
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209206
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 70000-0561_fc3c17b9-8f9f-4ff9-b24f-ff6df0ff4cecSPL ID fc3c17b9-8f9f-4ff9-b24f-ff6df0ff4cecSPL set ID 362b4a04-4a5f-4af6-9cd7-82aa172b7afbRxCUI 359818UNII 6M3C89ZY6RUPC 0096295139808
- 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
N470000056101followed by a unit qualifier and the quantityPackage 70000-0561-01. 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 70000-0561
- What is NDC 70000-0561?
- 70000-0561 is the product NDC for Maxi Nicotine (nicotine polacrilex), Nicotine 4 mg/1 lozenge, listed with the FDA by Cardinal Health (Leader) 70000. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Maxi Nicotine (Nicotine polacrilex).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- Cardinal Health (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 Maxi Nicotine?
- 3 other product NDCs are listed under this name. See all Maxi Nicotine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Maxi Nicotine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Maxi Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Rugby Laboratories, Inc. | 0536-1338 | 00536-1338-0900536-1338-35 |
| Maxi Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Walgreens | 0363-0960 | 00363-0960-0800363-0960-2400363-0960-27+1 more |
| Maxi Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Rite Aid Corporation | 11822-3317 | 11822-3317-0011822-3317-01 |
Other NDCs under ANDA 209206
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 |
|---|---|---|---|---|
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Walgreens | 0363-9580 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Walgreens | 0363-9570 |
| Nicotine Sugar Freenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | CVS Pharmacy | 69842-858 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 70000-0562 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Rugby Laboratories, Inc. | 0536-1337 |
| Maxi Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Rugby Laboratories, Inc. | 0536-1338 |
| Nicotine Sugar Freenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | CVS Pharmacy | 69842-957 |
| Maxi Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Rite Aid Corporation | 11822-3317 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-734 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-732 |