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NDC 42291-0927-56 varenicline 0.5 mg/1 Details
varenicline 0.5 mg/1
varenicline is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AvKARE. The primary component is VARENICLINE TARTRATE.
MedlinePlus Drug Summary
Varenicline is used along with education and counseling to help people stop smoking. Varenicline is in a class of medications called smoking cessation aids. It works by blocking the pleasant effects of nicotine (from smoking) on the brain.
Related Packages: 42291-0927-56Last Updated: 04/07/2024
MedLinePlus Full Drug Details: Varenicline
Product Information
| NDC | 42291-0927 |
|---|---|
| Product ID | 42291-927_0552b8e6-579f-60f5-e063-6394a90ad1bf |
| Associated GPIs | |
| GCN Sequence Number | 060896 |
| GCN Sequence Number Description | varenicline tartrate TABLET 0.5 MG ORAL |
| HIC3 | J3C |
| HIC3 Description | SMOKING DETERRENT-NICOTINIC RECEPT.PARTIAL AGONIST |
| GCN | 27046 |
| HICL Sequence Number | 033766 |
| HICL Sequence Number Description | VARENICLINE TARTRATE |
| Brand/Generic | Generic |
| Proprietary Name | varenicline |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | varenicline tartrate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 0.5 |
| Active Ingredient Units | mg/1 |
| Substance Name | VARENICLINE TARTRATE |
| Labeler Name | AvKARE |
| Pharmaceutical Class | Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA214557 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 42291-0927-56 (42291092756)
| NDC Package Code | 42291-927-56 |
|---|---|
| Billing NDC | 42291092756 |
| Package | 56 TABLET, FILM COATED in 1 BOTTLE (42291-927-56) |
| Marketing Start Date | 2023-09-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |