Prescription drug · ANDA
varenicline tartrate NDC 42571-459
Varenicline tartrate .5 mg/1 · Tablet, Film coated · Oral · Micro Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42571-459-82 | 42571045982 | 56 TABLET, FILM COATED in 1 BOTTLE (42571-459-82)Marketed from Dec 1, 2025 |
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/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Micro Labs Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218302
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Agonists (Mechanism)Partial Cholinergic Nicotinic Agonists (Mechanism)
- Identifiers
- Product ID 42571-459_426f1bdc-211b-b246-e063-6394a90a8de3SPL ID 426f1bdc-211b-b246-e063-6394a90a8de3SPL set ID ee603a5d-9a3c-4dbd-ba89-faf253dc8c42RxCUI 636671, 636676, 749289, 749788UNII 82269ASB48UPC 0342571460822, 0342571459826, 0342571460884, 0342571475840
- 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
N442571045982followed by a unit qualifier and the quantityPackage 42571-0459-82. 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 218302
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 1 mg/1 | Tablet, Film coatedOral | Micro Labs Limited | 42571-460 |
| Varenicline tartrate | — | Kit | Micro Labs Limited | 42571-475 |