Prescription drug · ANDA
Varenicline tartrate NDC 14445-154
Varenicline tartrate 1 mg/1 · Tablet, Film coated · Oral · Indoco Remedies Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 14445-154-02 | 1444501540214445015402 | 1 BLISTER PACK in 1 CARTON (14445-154-02) / 56 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Nov 1, 2024 | |
| 14445-154-56 | 1444501545614445015456 | 56 TABLET, FILM COATED in 1 BOTTLE (14445-154-56)Marketed from Nov 1, 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
- Active ingredients
- Varenicline tartrate — 1 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Indoco Remedies LimitedNDC labeler code 14445
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219106
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Agonists (Mechanism)Partial Cholinergic Nicotinic Agonists (Mechanism)
- Identifiers
- Product ID 14445-154_97b537d2-8829-42ad-86e9-8523b4430843SPL ID 97b537d2-8829-42ad-86e9-8523b4430843SPL set ID cd83bc6c-20f4-42e1-adb4-a3d1d89413f4RxCUI 636671, 636676, 749289UNII 82269ASB48UPC 0314445155011
- 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
N414445015402followed by a unit qualifier and the quantityPackage 14445-0154-02. 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 14445-154
- What is NDC 14445-154?
- 14445-154 is the product NDC for Varenicline tartrate, Varenicline tartrate 1 mg/1 tablet, film coated, listed with the FDA by Indoco Remedies Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Varenicline tartrate.
- What is the active ingredient?
- Varenicline tartrate.
- Who is the labeler?
- Indoco Remedies Limited, NDC labeler code 14445. 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 .5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7996 | 50090-7996-00 |
| Varenicline tartrate | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | Florida Pharmaceutical Products, LLC | 71921-308 | 71921-0308-56 |
Other NDCs under ANDA 219106
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 | — | Kit | Indoco Remedies Limited | 14445-155 |
| Vareniclinevarenicline tartrate | — | Kit | Florida Pharmaceutical Products, LLC | 71921-307 |
| Varenicline tartrate | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | Indoco Remedies Limited | 14445-153 |
| Varenicline tartrate | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7996 |
| Varenicline tartrate | Varenicline tartrate .5 mg/1 | Tablet, Film coatedOral | Florida Pharmaceutical Products, LLC | 71921-308 |
| Varenicline tartrate | Varenicline tartrate 1 mg/1 | Tablet, Film coatedOral | Florida Pharmaceutical Products, LLC | 71921-309 |