Over-the-counter drug · ANDA
Maxi Nicotine (Nicotine polacrilex) NDC 0536-1338
Nicotine 4 mg/1 · Lozenge · Oral · Rugby Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0536-1338-09 | 0053613380900536133809 | 3 BOTTLE, PLASTIC in 1 BOX (0536-1338-09) / 24 LOZENGE in 1 BOTTLE, PLASTICMarketed from Sep 17, 2021 | |
| 0536-1338-35 | 0053613383500536133835 | 24 LOZENGE in 1 BOTTLE, PLASTIC (0536-1338-35)Marketed from Sep 17, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Maxi Nicotine
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Lozenge
- Route
- Oral
- Labeler
- Rugby Laboratories, Inc.NDC labeler code 0536
- 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 0536-1338_21f25fb4-08b3-4f4f-ad3f-3b8e0c6836f2SPL ID 21f25fb4-08b3-4f4f-ad3f-3b8e0c6836f2SPL set ID 7c2e0872-75f6-4c4f-afff-3579375708deRxCUI 359818UNII 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
N400536133809followed by a unit qualifier and the quantityPackage 00536-1338-09. 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 0536-1338
- What is NDC 0536-1338?
- 0536-1338 is the product NDC for Maxi Nicotine (nicotine polacrilex), Nicotine 4 mg/1 lozenge, listed with the FDA by Rugby Laboratories, Inc.. It has 2 package NDCs, 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?
- Rugby Laboratories, Inc., NDC labeler code 0536. 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 | Walgreens | 0363-0960 | 00363-0960-0800363-0960-2400363-0960-27+1 more |
| Maxi Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Cardinal Health (Leader) 70000 | 70000-0561 | 70000-0561-01 |
| 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 |
| Maxi Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Cardinal Health (Leader) 70000 | 70000-0561 |
| 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 |
| 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 |