Prescription drug · ANDA
Varenicline NDC 70710-1613
Varenicline tartrate .5 mg/1 · Tablet, Film coated · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1613-6 | 70710161306 | 56 TABLET, FILM COATED in 1 BOTTLE (70710-1613-6)Marketed from Jun 13, 2023 |
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)
- Varenicline
- Generic name (nonproprietary)
- varenicline
- Active ingredients
- Varenicline tartrate — .5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216723
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Agonists (Mechanism)Partial Cholinergic Nicotinic Agonists (Mechanism)
- Identifiers
- Product ID 70710-1613_985b4791-e204-4342-9cab-052cccf4a730SPL ID 985b4791-e204-4342-9cab-052cccf4a730SPL set ID 1d4c9535-f185-4ea3-9140-60c4bb77f736RxCUI 636671, 636676UNII 82269ASB48UPC 0370710161361, 0370710161460
- 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
N470710161306followed by a unit qualifier and the quantityPackage 70710-1613-06. 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 are indicated for use as an aid to smoking cessation treatment. Varenicline 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.
Other NDCs under ANDA 216723
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 .5 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1773 |
| Varenicline | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1774 |
| Varenicline | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1614 |