Prescription drug · ANDA
Varenicline Tartrate NDC 85742-015
Varenicline tartrate .5 mg/561 · Tablet, Film coated · Oral · Kanchan Healthcare Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85742-015-15 | 8574200151585742001515 | 56 TABLET, FILM COATED in 1 BOTTLE (85742-015-15)Marketed from Oct 1, 2023 |
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)
- Varenicline Tartrate
- Generic name (nonproprietary)
- varenicline tartrate
- Active ingredients
- Varenicline tartrate — .5 mg/561
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Kanchan Healthcare IncNDC labeler code 85742
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217151
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Agonists (Mechanism)Partial Cholinergic Nicotinic Agonists (Mechanism)
- Identifiers
- Product ID 85742-015_bfc03c5c-16ca-4b83-af77-a9c539b87813SPL ID bfc03c5c-16ca-4b83-af77-a9c539b87813SPL set ID 1624125c-a0c7-49ee-be00-9bfae4ff9bf5RxCUI 636671, 636676, 749289, 749788UNII 82269ASB48UPC 0385742016152, 0385742015155, 0385742016169
- 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.
- NDC on a medical claim
N485742001515followed by a unit qualifier and the quantityPackage 85742-0015-15. 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)
Varenicline tablets is indicated for use as an aid to smoking cessation treatment. Varenicline tablets 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 85742-015
- What is NDC 85742-015?
- 85742-015 is the product NDC for Varenicline Tartrate, Varenicline tartrate .5 mg/561 tablet, film coated, listed with the FDA by Kanchan Healthcare Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Varenicline Tartrate.
- What is the active ingredient?
- Varenicline tartrate.
- Who is the labeler?
- Kanchan Healthcare Inc, NDC labeler code 85742. 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 Tartrate?
- 21 other product NDCs are listed under this name. See all Varenicline Tartrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Varenicline Tartrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| varenicline tartrate | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | Micro Labs Limited | 42571-459 | 42571-0459-82 |
| varenicline tartrate | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Micro Labs Limited | 42571-460 | 42571-0460-8242571-0460-88 |
| Varenicline tartrate | — | Kit | Micro Labs Limited | 42571-475 | 42571-0475-84 |
| varenicline tartrate | — | KitOral | Dr. Reddys Laboratories Inc. | 43598-022 | 43598-0022-56 |
| varenicline tartrate | — | KitOral | Dr. Reddys Laboratories Inc. | 43598-023 | 43598-0023-53 |
| varenicline tartrate | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | Dr. Reddys Laboratories Inc. | 43598-907 | 43598-0907-56 |
| varenicline tartrate | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Dr. Reddys Laboratories Inc. | 43598-908 | 43598-0908-56 |
| Varenicline tartrate | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | Indoco Remedies Limited | 14445-153 | 14445-0153-56 |
| Varenicline tartrate | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Indoco Remedies Limited | 14445-154 | 14445-0154-0214445-0154-56 |
| Varenicline tartrate | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7996 | 50090-7996-00 |
Other NDCs under ANDA 217151
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 Tartrate | Varenicline tartrate .5 mg/561 | Tablet, Film coatedOral | Leading Pharma, LLC | 69315-402 |
| Varenicline Tartrate | Varenicline tartrate 1 mg/561 | Tablet, Film coatedOral | Leading Pharma, LLC | 69315-403 |
| Varenicline Tartrate | — | Kit | Leading Pharma, LLC | 69315-404 |
| Varenicline Tartrate | Varenicline tartrate 1 mg/561 | Tablet, Film coatedOral | Kanchan Healthcare Inc | 85742-016 |
| Varenicline Tartrate | — | Kit | Kanchan Healthcare Inc | 85742-017 |