Prescription drug · ANDA
Varenicline Tartrate NDC 70748-125
Kit · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70748-125-13 | 7074801251370748012513 | 1 BLISTER PACK in 1 CARTON (70748-125-13) / 1 KIT in 1 BLISTER PACKMarketed from Mar 20, 2024 |
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
- Dosage form
- Kit
- Labeler
- Lupin Pharmaceuticals, Inc.NDC labeler code 70748
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211862
- Marketing start
- Listing expires
- Identifiers
- Product ID 70748-125_3647a217-0da1-4778-adea-08d19a9c446fSPL ID 3647a217-0da1-4778-adea-08d19a9c446fSPL set ID bf20c4cc-1731-4873-8de1-b93d17591e9fRxCUI 636671, 636676, 749289UNII 82269ASB48UPC 0370748128497, 0370748127490
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
N470748012513followed by a unit qualifier and the quantityPackage 70748-0125-13. 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 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 70748-125
- What is NDC 70748-125?
- 70748-125 is the product NDC for Varenicline Tartrate kit, listed with the FDA by Lupin Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Varenicline Tartrate.
- Who is the labeler?
- Lupin Pharmaceuticals, Inc., NDC labeler code 70748. 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 Tartrate?
- 21 other product NDCs are listed under this name. See all Varenicline Tartrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Varenicline Tartrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| varenicline tartrate | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | Micro Labs Limited | 42571-459 | 42571-0459-82 |
| varenicline tartrate | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Micro Labs Limited | 42571-460 | 42571-0460-8242571-0460-88 |
| Varenicline tartrate | — | Kit | Micro Labs Limited | 42571-475 | 42571-0475-84 |
| varenicline tartrate | — | KitOral | Dr. Reddys Laboratories Inc. | 43598-022 | 43598-0022-56 |
| varenicline tartrate | — | KitOral | Dr. Reddys Laboratories Inc. | 43598-023 | 43598-0023-53 |
| varenicline tartrate | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | Dr. Reddys Laboratories Inc. | 43598-907 | 43598-0907-56 |
| varenicline tartrate | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Dr. Reddys Laboratories Inc. | 43598-908 | 43598-0908-56 |
| Varenicline tartrate | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | Indoco Remedies Limited | 14445-153 | 14445-0153-56 |
| Varenicline tartrate | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Indoco Remedies Limited | 14445-154 | 14445-0154-0214445-0154-56 |
| Varenicline tartrate | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7996 | 50090-7996-00 |
Other NDCs under ANDA 211862
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 | 50090-7997 |
| Varenicline | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 70748-127 |
| Varenicline | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 70748-128 |