Over-the-counter drug · ANDA
Nicotine (Nicotine polacrilex) NDC 58602-904
Nicotine 4 mg/1 · Lozenge · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-904-07 | 5860209040758602090407 | 1 CONTAINER in 1 CARTON (58602-904-07) / 24 LOZENGE in 1 CONTAINERMarketed from Jun 24, 2022 | |
| 58602-904-51 | 5860209045158602090451 | 3 CONTAINER in 1 CARTON (58602-904-51) / 24 LOZENGE in 1 CONTAINERMarketed from Jun 24, 2022 | |
| 58602-904-65 | 5860209046558602090465 | 6 CONTAINER in 1 CARTON (58602-904-65) / 24 LOZENGE in 1 CONTAINERMarketed from Jun 24, 2022 |
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
- Aurohealth LLCNDC labeler code 58602
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213266
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 58602-904_810932e0-a982-400a-b43d-b847152f685bSPL ID 810932e0-a982-400a-b43d-b847152f685bSPL set ID 810932e0-a982-400a-b43d-b847152f685bRxCUI 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
N458602090407followed by a unit qualifier and the quantityPackage 58602-0904-07. 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 58602-904
- What is NDC 58602-904?
- 58602-904 is the product NDC for Nicotine (nicotine polacrilex), Nicotine 4 mg/1 lozenge, listed with the FDA by Aurohealth LLC. It has 3 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?
- Aurohealth LLC, NDC labeler code 58602. 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 213266
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 |
|---|---|---|---|---|
| Amazon Basic Care Nicotine Polacrilexnicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-266 |
| Amazon Basic Care Nicotine Polacrilexnicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-623 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Atlantic Biologicals Corp. | 17856-0906 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Aurohealth LLC | 58602-835 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Aurohealth LLC | 58602-836 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Aurohealth LLC | 58602-903 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Aurohealth LLC | 58602-905 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Aurohealth LLC | 58602-906 |