Over-the-counter drug · ANDA
Nicotine Polacrilex NDC 11822-2331
Nicotine 2 mg/1 · Gum, Chewing · Oral · Rite Aid Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11822-2331-2 | 1182223310211822233102 | 100 BLISTER PACK in 1 CARTON (11822-2331-2) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 31, 2020 | |
| 11822-2331-3 | 1182223310311822233103 | 20 BLISTER PACK in 1 CARTON (11822-2331-3) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 31, 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)
- Nicotine Polacrilex
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 2 mg/1
- Dosage form
- Gum, Chewing
- Route
- Oral
- Labeler
- Rite Aid CorporationNDC labeler code 11822
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079216
- Marketing start
- Marketing end
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 11822-2331_ebfa6248-67a2-4c92-96cf-0d9adcd13ae5SPL ID ebfa6248-67a2-4c92-96cf-0d9adcd13ae5SPL set ID 63a433aa-8c73-47a0-be64-8708f8478fffRxCUI 314119UNII 6M3C89ZY6RUPC 0011822009300
- 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
N411822233102followed by a unit qualifier and the quantityPackage 11822-2331-02. 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 11822-2331
- What is NDC 11822-2331?
- 11822-2331 is the product NDC for Nicotine Polacrilex, Nicotine 2 mg/1 gum, chewing, listed with the FDA by Rite Aid Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nicotine Polacrilex.
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- Rite Aid Corporation, NDC labeler code 11822. 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?
- 48 other product NDCs are listed under this name. See all Nicotine Polacrilex 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 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 | Nicotine 2 mg/1 | Gum, ChewingOral | Lucy Goods, Inc. | 72224-927 | 72224-0927-10 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Lucy Goods, Inc. | 72224-924 | 72224-0924-10 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Lucy Goods, Inc. | 72224-925 | 72224-0925-10 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Lucy Goods, Inc. | 72224-933 | 72224-0933-10 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-976 | 55910-0976-20 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Quitine LLC | 84720-927 | 84720-0927-03 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Quitine LLC | 84720-933 | 84720-0933-03 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-796 | 55910-0796-20 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-933 | 55910-0933-10 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | A-S Medication Solutions | 50090-8146 | 50090-8146-00 |
Other NDCs under ANDA 079216
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 |
|---|---|---|---|---|
| Habitrol Nicotine Polacrilex 2 mg Coated Cinnamonnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Dr. Reddy's Laboratories Inc. | 55741-004 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Rugby Laboratories | 0536-3404 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | H E B | 37808-820 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Walgreens | 0363-9240 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Lucy Goods, Inc. | 72224-924 |
| Nicotine Polacrilex coated cinnamonnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | CVS Pharmacy | 69842-026 |