Over-the-counter drug · ANDA
Nicotine (Nicotine polacrilex) NDC 59726-913
Nicotine 4 mg/1 · Gum, Chewing · Oral · P & L Development, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59726-913-16 | 5972609131659726091316 | 160 BLISTER PACK in 1 CARTON (59726-913-16) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Mar 1, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Gum, Chewing
- Route
- Oral
- Labeler
- P & L Development, LLCNDC labeler code 59726
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079038
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 59726-913_ecd9cb80-d22d-4582-bf97-cb227fef1d55SPL ID ecd9cb80-d22d-4582-bf97-cb227fef1d55SPL set ID fbb3f6af-529f-40d8-a193-1aed4f2aa769RxCUI 311975UNII 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
N459726091316followed by a unit qualifier and the quantityPackage 59726-0913-16. 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 59726-913
- What is NDC 59726-913?
- 59726-913 is the product NDC for Nicotine (nicotine polacrilex), Nicotine 4 mg/1 gum, chewing, listed with the FDA by P & L Development, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nicotine (Nicotine Polacrilex).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- P & L Development, LLC, NDC labeler code 59726. 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?
- 197 other product NDCs are listed under this name. See all Nicotine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other 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) |
|---|---|---|---|---|---|
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-684 | 72288-0684-02 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-730 | 72288-0730-60 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-755 | 72288-0755-06 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-863 | 72288-0863-06 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Safeway | 21130-772 | 21130-0772-02 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-969 | 72288-0969-76 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-869 | 72288-0869-76 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Cardinal Health 107, LLC | 55154-6818 | 55154-6818-00 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-651 | 72288-0651-14 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Walgreen Company | 0363-2511 | 00363-2511-27 |
Other NDCs under ANDA 079038
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 Coated Fruitnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Publix Supermarkets, Inc. | 56062-504 |
| Rugby Nicotine Polacrilex Gum, Coated Fruit Flavornicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Rugby Laboratories | 0536-3387 |
| Nicotine Polacrilex coated fruitnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | CVS Pharmacy | 69842-025 |
| Nicotine Polacrilex Coated Fruitnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 70000-0342 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Lucy Goods, Inc. | 72224-931 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Walgreens | 0363-9310 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-918 |
| Habitrol Nicotine Polacrilex Gum 4 mg Coated Fruitnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Dr. Reddy's Laboratories Inc. | 75907-300 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | AAFES/Your Military Exchanges | 55301-504 |