Prescription drug · ANDA
Varenicline (Varenicline tartrate) NDC 60687-648
Varenicline tartrate 1 mg/1 · Tablet, Film coated · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-648-21 | 6068706482160687064821 | 30 BLISTER PACK in 1 CARTON (60687-648-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-648-11)Marketed from Feb 11, 2022 |
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 — 1 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- American Health PackagingNDC labeler code 60687
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201785
- Marketing start
- Marketing end
- Other FDA classes
- Cholinergic Agonists (Mechanism)Partial Cholinergic Nicotinic Agonists (Mechanism)
- Identifiers
- Product ID 60687-648_4599c6fb-66cd-c7fe-e063-6294a90ac97fSPL ID 4599c6fb-66cd-c7fe-e063-6294a90ac97fSPL set ID 16a03b5e-03e0-4b0b-92a4-aaf0669906f7RxCUI 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
N460687064821followed by a unit qualifier and the quantityPackage 60687-0648-21. 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 60687-648
- What is NDC 60687-648?
- 60687-648 is the product NDC for Varenicline (varenicline tartrate), Varenicline tartrate 1 mg/1 tablet, film coated, listed with the FDA by American Health Packaging. 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?
- American Health Packaging, NDC labeler code 60687. 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 201785
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 .5 mg/1 | Tablet, Film coatedOral | Par Health USA, LLC | 49884-155 |
| Vareniclinevarenicline tartrate | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Par Health USA, LLC | 49884-156 |
| Vareniclinevarenicline tartrate | — | Kit | Par Health USA, LLC | 49884-944 |