Prescription drug · ANDA
Varenicline NDC 50090-6447
Varenicline tartrate .5 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6447-0 | 5009064470050090644700 | 56 TABLET, FILM COATED in 1 BOTTLE (50090-6447-0)Marketed from Apr 20, 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
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- 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 50090-6447_6cc32177-9e49-494f-b049-d115c0840056SPL ID 6cc32177-9e49-494f-b049-d115c0840056SPL set ID 99414eca-c601-431c-8e84-2066b2e8221cRxCUI 636671UNII 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
N450090644700followed by a unit qualifier and the quantityPackage 50090-6447-00. 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 tablets are 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 50090-6447
- What is NDC 50090-6447?
- 50090-6447 is the product NDC for Varenicline, Varenicline tartrate .5 mg/1 tablet, film coated, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Varenicline.
- What is the active ingredient?
- Varenicline tartrate.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. 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 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 1 mg/1 | Tablet, Film coatedOral | Apotex Corp | 60505-4795 |
| 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 |