Prescription drug · ANDA
varenicline (varenicline tartrate) NDC 42291-927
Varenicline tartrate .5 mg/1 · Tablet, Film coated · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-927-56 | 42291092756 | 56 TABLET, FILM COATED in 1 BOTTLE (42291-927-56)Marketed from Sep 14, 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
- Generic name (nonproprietary)
- varenicline tartrate
- Active ingredients
- Varenicline tartrate — .5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214557
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Agonists (Mechanism)Partial Cholinergic Nicotinic Agonists (Mechanism)
- Identifiers
- Product ID 42291-927_48bfad2d-97de-5ed7-e063-6394a90a2e86SPL ID 48bfad2d-97de-5ed7-e063-6394a90a2e86SPL set ID 0552d7ff-9fe8-9c9f-e063-6394a90a79feRxCUI 636671, 636676, 749289UNII 82269ASB48
- 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
N442291092756followed by a unit qualifier and the quantityPackage 42291-0927-56. 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 tablet is indicated for use as an aid to smoking cessation treatment. Varenicline tablet 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 214557
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 |
|---|---|---|---|---|
| Vareniclinevarenicline tartrate | — | Kit | AvKARE | 42291-929 |
| vareniclinevarenicline tartrate | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-928 |
| vareniclinevarenicline tartrate | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7135 |
| vareniclinevarenicline tartrate | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7182 |
| vareniclinevarenicline tartrate | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7413 |
| vareniclinevarenicline tartrate | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7414 |
| vareniclinevarenicline tartrate | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-744 |
| vareniclinevarenicline tartrate | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-743 |
| Vareniclinevarenicline tartrate | — | Kit | Ascend Laboratories, LLC | 67877-745 |
| Vareniclinevarenicline tartrate | — | Kit | Major Pharmaceuticals | 0904-7415 |