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NDC 69315-0403-56 VARENICLINE TARTRATE 1 mg/561 Details
VARENICLINE TARTRATE 1 mg/561
VARENICLINE TARTRATE is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Leading Pharma, LLC. 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: 69315-0403-56Last Updated: 05/05/2024
MedLinePlus Full Drug Details: Varenicline
Product Information
| NDC | 69315-0403 |
|---|---|
| Product ID | 69315-403_73d01bd5-c900-436d-8a67-de772f720875 |
| Associated GPIs | |
| GCN Sequence Number | 060897 |
| GCN Sequence Number Description | varenicline tartrate TABLET 1 MG ORAL |
| HIC3 | J3C |
| HIC3 Description | SMOKING DETERRENT-NICOTINIC RECEPT.PARTIAL AGONIST |
| GCN | 27047 |
| HICL Sequence Number | 033766 |
| HICL Sequence Number Description | VARENICLINE TARTRATE |
| Brand/Generic | Generic |
| Proprietary Name | VARENICLINE TARTRATE |
| 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 | 1 |
| Active Ingredient Units | mg/561 |
| Substance Name | VARENICLINE TARTRATE |
| Labeler Name | Leading Pharma, LLC |
| 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 | ANDA217151 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69315-0403-56 (69315040356)
| NDC Package Code | 69315-403-56 |
|---|---|
| Billing NDC | 69315040356 |
| Package | 56 TABLET, FILM COATED in 1 BOTTLE (69315-403-56) |
| Marketing Start Date | 2023-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 2.22717 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | VARENICLINE 1 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis