Over-the-counter drug · ANDA
Nicotine Mini (Nicotine polacrilex) NDC 0536-1239
Nicotine 2 mg/1 · Lozenge · Oral · Rugby Laboratories, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0536-1239Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00536-1239Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0536-1239-27 | 0053612392700536123927 | 1 BOTTLE, PLASTIC in 1 BOX (0536-1239-27) / 27 LOZENGE in 1 BOTTLE, PLASTICMarketed from Jul 31, 2019 | |
| 0536-1239-81 | 0053612398100536123981 | 3 BOTTLE, PLASTIC in 1 BOX (0536-1239-81) / 27 LOZENGE in 1 BOTTLE, PLASTICMarketed from Jul 31, 2019 |
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)
- Nicotine Mini
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 2 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 207868
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 0536-1239_4eae8948-a3c6-4ca1-8c88-0ab5ac393532SPL ID 4eae8948-a3c6-4ca1-8c88-0ab5ac393532SPL set ID be17cbe9-43bb-424e-9d91-fba4f02691bbRxCUI 359817UNII 6M3C89ZY6RUPC 0305361239817
- 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
N400536123927followed by a unit qualifier and the quantityPackage 00536-1239-27. 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 0536-1239
- What is NDC 0536-1239?
- 0536-1239 is the product NDC for Nicotine Mini (nicotine polacrilex), Nicotine 2 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?
- Nicotine Mini (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 Nicotine Mini?
- 34 other product NDCs are listed under this name. See all Nicotine Mini NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nicotine Mini 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 mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-789 | 72288-0789-07 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-739 | 72288-0739-14 |
| nicotine mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-797 | 72288-0797-14 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-375 | 72288-0375-0172288-0375-07 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-569 | 72288-0569-0172288-0569-0472288-0569-07 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | P & L Development, LLC | 59726-652 | 59726-0652-0459726-0652-27 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | HC Jones, Inc. | 83253-979 | 83253-0979-1883253-0979-2783253-0979-72+1 more |
| nicotine mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Walgreen Company | 0363-6011 | 00363-6011-07 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Walgreen Company | 0363-7051 | 00363-7051-07 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | A-S Medication Solutions | 50090-8151 | 50090-8151-00 |
Other NDCs under ANDA 207868
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 |
|---|---|---|---|---|
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Walgreens | 0363-2640 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Rugby Laboratories, Inc. | 0536-1241 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | ATLANTIC BIOLOGICALS CORP. | 17856-1241 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-716 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-436 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-662 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | P & L Development, LLC | 59726-264 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Chain Drug Consortium, LLC | 68016-087 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | WALMART INC. (see also Equate) | 79903-128 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | HC Jones, Inc. | 83253-264 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | CVS Pharmacy | 69842-564 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Walgreens | 0363-0262 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Rite Aid Corporation | 11822-3315 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | ATLANTIC BIOLOGICALS CORP. | 17856-1239 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-715 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-731 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-493 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | A-S Medication Solutions | 50090-8151 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Rising Pharma Holdings, Inc. | 57237-320 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Rising Pharma Holdings, Inc. | 57237-321 |
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