Over-the-counter drug · ANDA
Nicotine (nicotine polacrilex) NDC 69842-564
Nicotine 4 mg/1 · Lozenge · Oral · CVS Pharmacy
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69842-564-10 | 69842056410 | 1 BOTTLE, PLASTIC in 1 BOX (69842-564-10) / 10 LOZENGE in 1 BOTTLE, PLASTICMarketed from May 29, 2020 | |
| 69842-564-20 | 69842056420 | 1 BOTTLE, PLASTIC in 1 BOX (69842-564-20) / 20 LOZENGE in 1 BOTTLE, PLASTICMarketed from May 29, 2020 | |
| 69842-564-27 | 69842056427 | 1 BOTTLE, PLASTIC in 1 BOX (69842-564-27) / 27 LOZENGE in 1 BOTTLE, PLASTICMarketed from May 29, 2020 | |
| 69842-564-35 | 69842056435 | 5 BOTTLE, PLASTIC in 1 BOX (69842-564-35) / 27 LOZENGE in 1 BOTTLE, PLASTICMarketed from May 29, 2020 | |
| 69842-564-81 | 69842056481 | 3 BOTTLE, PLASTIC in 1 BOX (69842-564-81) / 27 LOZENGE in 1 BOTTLE, PLASTICMarketed from May 29, 2020 |
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
- Lozenge
- Route
- Oral
- Labeler
- CVS Pharmacy
- 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 69842-564_da20b0a7-14b7-49eb-90c7-86cc890aff8bSPL ID da20b0a7-14b7-49eb-90c7-86cc890aff8bSPL set ID 7fa848c6-3a4a-41f3-b927-1b26b6232e3aRxCUI 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
N469842056410followed by a unit qualifier and the quantityPackage 69842-0564-10. 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.
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 | ATLANTIC BIOLOGICALS CORP. | 17856-1241 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Rite Aid Corporation | 11822-3315 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Walgreens | 0363-0262 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Rugby Laboratories, Inc. | 0536-1239 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Rugby Laboratories, Inc. | 0536-1241 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Cardinal Health (Leader) 70000 | 70000-0559 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Cardinal Health (Leader) 70000 | 70000-0560 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-662 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | HC Jones, Inc. | 83253-264 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | HC Jones, Inc. | 83253-262 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | WALMART INC. (see also Equate) | 79903-127 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | WALMART INC. (see also Equate) | 79903-128 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | P & L Development, LLC | 59726-262 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Walgreens | 0363-2640 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | P & L Development, LLC | 59726-264 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | PLD Acquisitions LLC DBA Avma Pharma Solutions | 63548-0264 |
| Nicotine Sugar Freenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | CVS Pharmacy | 69842-662 |
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | PLD Acquisitions LLC DBA Avma Pharma Solutions | 63548-0262 |
| 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 | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-716 |
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