Prescription drug · NDA
Chantix (Varenicline tartrate) NDC 43353-899
Varenicline tartrate 1 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43353-899-05 | 4335308990543353089905 | 4200 TABLET, FILM COATED in 1 BOTTLE (43353-899-05)Marketed from Mar 7, 2014 |
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)
- Chantix
- Generic name (nonproprietary)
- varenicline tartrate
- Active ingredients
- Varenicline tartrate — 1 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 43353
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021928
- Marketing start
- Listing expires
- Other FDA classes
- Partial Cholinergic Nicotinic Agonists (Mechanism)
- Identifiers
- Product ID 43353-899_45cfd34d-08ac-40a8-95b3-21d3fea687c3SPL ID 45cfd34d-08ac-40a8-95b3-21d3fea687c3SPL set ID b4403cea-6300-4d89-8fde-5149a80b08b9RxCUI 636676, 637190UNII 82269ASB48
- Pharmacologic class
- Partial 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
N443353089905followed by a unit qualifier and the quantityPackage 43353-0899-05. 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)
CHANTIX is indicated for use as an aid to smoking cessation treatment. CHANTIX is a nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment. ( 1 and 2.1 )
Excerpt only. Read the full label for complete information.
About NDC 43353-899
- What is NDC 43353-899?
- 43353-899 is the product NDC for Chantix (varenicline tartrate), Varenicline tartrate 1 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Chantix (Varenicline tartrate).
- What is the active ingredient?
- Varenicline tartrate.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Chantix?
- 5 other product NDCs are listed under this name. See all Chantix NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Chantix products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Chantixvarenicline tartrate | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0468 | 00069-0468-56 |
| Chantixvarenicline tartrate | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0469 | 00069-0469-2800069-0469-56 |
| Chantixvarenicline tartrate | — | Kit | Pfizer Laboratories Div Pfizer Inc | 0069-0471 | 00069-0471-28 |
| Chantixvarenicline tartrate | — | Kit | Proficient Rx LP | 63187-618 | 63187-0618-53 |
| Chantixvarenicline tartrate | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-381 | 71205-0381-56 |
Other NDCs under NDA 021928
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 |
|---|---|---|---|---|
| Chantixvarenicline tartrate | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0468 |
| Chantixvarenicline tartrate | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0469 |
| Chantixvarenicline tartrate | — | Kit | Pfizer Laboratories Div Pfizer Inc | 0069-0471 |
| Chantixvarenicline tartrate | — | Kit | Proficient Rx LP | 63187-618 |
| Chantixvarenicline tartrate | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-381 |