Prescription drug · ANDA
Varenicline (Varenicline tartrate) NDC 42291-929
Kit · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-929-53 | 4229109295342291092953 | 1 KIT in 1 CARTON (42291-929-53) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACKMarketed 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
- Dosage form
- Kit
- Labeler
- AvKARENDC labeler code 42291
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214557
- Marketing start
- Listing expires
- Identifiers
- Product ID 42291-929_48bfad2d-97de-5ed7-e063-6394a90a2e86SPL ID 48bfad2d-97de-5ed7-e063-6394a90a2e86SPL set ID 0552d7ff-9fe8-9c9f-e063-6394a90a79feRxCUI 636671, 636676, 749289UNII 82269ASB48
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N442291092953followed by a unit qualifier and the quantityPackage 42291-0929-53. 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.
About NDC 42291-929
- What is NDC 42291-929?
- 42291-929 is the product NDC for Varenicline (varenicline tartrate) kit, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Varenicline (Varenicline tartrate).
- Who is the labeler?
- AvKARE, NDC labeler code 42291. 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 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 | 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 | — | Kit | Major Pharmaceuticals | 0904-7415 |
| vareniclinevarenicline tartrate | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-927 |
| 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 | Ascend Laboratories, LLC | 67877-743 |
| vareniclinevarenicline tartrate | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-744 |
| Vareniclinevarenicline tartrate | — | Kit | Ascend Laboratories, LLC | 67877-745 |