Over-the-counter drug · ANDA
Nicotine (Nicotine polacrilex) NDC 70000-0562
Nicotine 2 mg/1 · Lozenge · Oral · CARDINAL HEALTH 110, LLC. DBA LEADER 70000
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0562-1 | 7000005620170000056201 | 3 BOTTLE, PLASTIC in 1 BOX (70000-0562-1) / 24 LOZENGE in 1 BOTTLE, PLASTICMarketed from Jul 1, 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
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 2 mg/1
- Dosage form
- Lozenge
- Route
- Oral
- Labeler
- CARDINAL HEALTH 110, LLC. DBA LEADER 70000NDC labeler code 70000
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209206
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 70000-0562_2ce3403a-7547-45d6-8dda-116c275a6e24SPL ID 2ce3403a-7547-45d6-8dda-116c275a6e24
- 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
N470000056201followed by a unit qualifier and the quantityPackage 70000-0562-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70000-0562
- What is NDC 70000-0562?
- 70000-0562 is the product NDC for Nicotine (nicotine polacrilex), Nicotine 2 mg/1 lozenge, listed with the FDA by CARDINAL HEALTH 110, LLC. DBA LEADER 70000. 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?
- CARDINAL HEALTH 110, LLC. DBA LEADER 70000, NDC labeler code 70000. 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 209206
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 4 mg/1 | LozengeOral | Walgreens | 0363-9580 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Walgreens | 0363-9570 |
| Nicotine Sugar Freenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | CVS Pharmacy | 69842-858 |
| Maxi Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Cardinal Health (Leader) 70000 | 70000-0561 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Rugby Laboratories, Inc. | 0536-1337 |
| Maxi Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Rugby Laboratories, Inc. | 0536-1338 |
| Nicotine Sugar Freenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | CVS Pharmacy | 69842-957 |
| Maxi Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Rite Aid Corporation | 11822-3317 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-734 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-732 |