Over-the-counter drug · ANDA
Nicotine (Nicotine polacrilex) NDC 83253-978
Nicotine 2 mg/1 · Lozenge · Oral · HC Jones, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83253-978-18 | 8325309781883253097818 | 4 BOTTLE, PLASTIC in 1 BOX (83253-978-18) / 27 LOZENGE in 1 BOTTLE, PLASTICMarketed from Sep 10, 2026 | |
| 83253-978-27 | 8325309782783253097827 | 27 LOZENGE in 1 BOTTLE, PLASTIC (83253-978-27)Marketed from Mar 31, 2025 | |
| 83253-978-72 | 8325309787283253097872 | 1 BOTTLE, PLASTIC in 1 BOX (83253-978-72) / 27 LOZENGE in 1 BOTTLE, PLASTICMarketed from Mar 31, 2025 | |
| 83253-978-81 | 8325309788183253097881 | 3 BOTTLE, PLASTIC in 1 BOX (83253-978-81) / 27 LOZENGE in 1 BOTTLE, PLASTICMarketed from Mar 31, 2025 |
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 — 2 mg/1
- Dosage form
- Lozenge
- Route
- Oral
- Labeler
- HC Jones, Inc.NDC labeler code 83253
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210711
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 83253-978_17b90a4f-a5fc-4696-9bb0-f6fd71534348SPL ID 17b90a4f-a5fc-4696-9bb0-f6fd71534348SPL set ID e07226e8-3be4-46e4-aa4f-c5d88db1ccfaRxCUI 359817UNII 6M3C89ZY6RUPC 0850083379094
- 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
N483253097818followed by a unit qualifier and the quantityPackage 83253-0978-18. 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 83253-978
- What is NDC 83253-978?
- 83253-978 is the product NDC for Nicotine (nicotine polacrilex), Nicotine 2 mg/1 lozenge, listed with the FDA by HC Jones, Inc.. It has 4 package NDCs, 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?
- HC Jones, Inc., NDC labeler code 83253. 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 210711
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 2 mg/1 | LozengeOral | Walgreens | 0363-9780 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | P & L Development, LLC | 59726-650 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | P & L Development, LLC | 59726-652 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | HC Jones, Inc. | 83253-979 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Walgreens | 0363-0979 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Walgreens | 0363-5760 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Walgreens | 0363-5770 |
| Nicotine Sugar Freenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | CVS Pharmacy | 69842-932 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | CVS Pharmacy | 69842-934 |