Prescription drug · NDA
Chantix (Varenicline tartrate) NDC 63187-618
Kit · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-618-53 | 6318706185363187061853 | 1 KIT in 1 CARTON (63187-618-53) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Dec 1, 2018 |
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
- Dosage form
- Kit
- Labeler
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021928
- Marketing start
- Listing expires
- Identifiers
- Product ID 63187-618_1da9a839-db61-41e9-a214-d007b8f59820SPL ID 1da9a839-db61-41e9-a214-d007b8f59820SPL set ID 0fefd790-b526-4f2f-8c83-5f39f7306556RxCUI 636671, 636676, 637188, 637190, 749289, 795737
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N463187061853followed by a unit qualifier and the quantityPackage 63187-0618-53. 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 . This label includes a boxed warning.
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 63187-618
- What is NDC 63187-618?
- 63187-618 is the product NDC for Chantix (varenicline tartrate) kit, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Chantix (Varenicline tartrate).
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 63187. 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 | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-899 | 43353-0899-05 |
| 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 | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-899 |
| Chantixvarenicline tartrate | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-381 |