Prescription drug · ANDA
Varenicline NDC 60505-4795
Varenicline tartrate 1 mg/1 · Tablet, Film coated · Oral · Apotex Corp
NDC codes
FDA NDC DirectoryProduct NDC (as listed)60505-4795Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60505-4795Add the package segment from the table below.
Product information
- Brand name (proprietary)
- Varenicline
- Generic name (nonproprietary)
- varenicline
- Active ingredients
- Varenicline tartrate — 1 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Apotex CorpNDC labeler code 60505
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201962
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Agonists (Mechanism)Partial Cholinergic Nicotinic Agonists (Mechanism)
- Identifiers
- Product ID 60505-4795_82c3cf49-a3f0-4566-3049-6f52d8d08a74SPL ID 82c3cf49-a3f0-4566-3049-6f52d8d08a74
- Pharmacologic class
- Cholinergic Receptor Agonist; 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.
Product label
The FDA listing for this product does not reference a label (SPL) set.
About NDC 60505-4795
- What is NDC 60505-4795?
- 60505-4795 is the product NDC for Varenicline, Varenicline tartrate 1 mg/1 tablet, film coated, listed with the FDA by Apotex Corp.
- What drug is associated with this NDC?
- Varenicline.
- What is the active ingredient?
- Varenicline tartrate.
- Who is the labeler?
- Apotex Corp, NDC labeler code 60505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Varenicline?
- 56 other product NDCs are listed under this name. See all Varenicline NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Varenicline products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Vareniclinevarenicline tartrate | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4647 | 70518-4647-00 |
| Varenicline | Varenicline tartrate .5 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-077 | 60290-0077-0160290-0077-02 |
| Varenicline | Varenicline tartrate 1 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-078 | 60290-0078-0160290-0078-0260290-0078-03 |
| varenicline | — | Kit | Umedica Laboratories USA Inc. | 60290-095 | 60290-0095-01 |
| Vareniclinevarenicline tartrate | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-893 | 60687-0893-21 |
| Varenicline | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-417 | 59651-0417-56 |
| Varenicline | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-418 | 59651-0418-5559651-0418-56 |
| Varenicline | — | Kit | Aurobindo Pharma Limited | 59651-451 | 59651-0451-53 |
| Vareniclinevarenicline tartrate | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals, Inc. | 10135-808 | 10135-0808-56 |
| Vareniclinevarenicline tartrate | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals, Inc. | 10135-809 | 10135-0809-56 |
Other NDCs under ANDA 201962
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 |
|---|---|---|---|---|
| Varenicline | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6446 |
| Varenicline | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6447 |
| Varenicline | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-032 |
| Varenicline | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | Apotex Corp | 60505-3613 |
| Varenicline | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Apotex Corp | 60505-3614 |
| Varenicline | — | KitOral | Apotex Corp | 60505-3615 |
| Varenicline | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | Apotex Corp | 60505-4794 |
| Varenicline | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2218 |
| Varenicline | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2219 |