Prescription drug · ANDA
Varenicline (Varenicline tartrate) NDC 10135-808
Varenicline tartrate .5 mg/1 · Tablet, Film coated · Oral · Marlex Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10135-808-56 | 1013508085610135080856 | 56 TABLET, FILM COATED in 1 BOTTLE (10135-808-56)Marketed from Jan 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
- Generic name (nonproprietary)
- varenicline tartrate
- Active ingredients
- Varenicline tartrate — .5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Marlex Pharmaceuticals, Inc.NDC labeler code 10135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217283
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Agonists (Mechanism)Partial Cholinergic Nicotinic Agonists (Mechanism)
- Identifiers
- Product ID 10135-808_4db2ad18-c1a0-81b8-e063-6394a90ac1d1SPL ID 4db2ad18-c1a0-81b8-e063-6394a90ac1d1SPL set ID 29b6b4ca-aeef-1295-e063-6394a90a21b9RxCUI 636671, 636676UNII 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
N410135080856followed by a unit qualifier and the quantityPackage 10135-0808-56. 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 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.
About NDC 10135-808
- What is NDC 10135-808?
- 10135-808 is the product NDC for Varenicline (varenicline tartrate), Varenicline tartrate .5 mg/1 tablet, film coated, listed with the FDA by Marlex Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Varenicline (Varenicline tartrate).
- What is the active ingredient?
- Varenicline tartrate.
- Who is the labeler?
- Marlex Pharmaceuticals, Inc., NDC labeler code 10135. 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 1 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals, Inc. | 10135-809 | 10135-0809-56 |
| Varenicline | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-489 | 33342-0489-19 |
Other NDCs under ANDA 217283
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 | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals, Inc. | 10135-809 |