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NDC 00536-1338-09 Maxi Nicotine 4 mg/1 Details
Maxi Nicotine 4 mg/1
Maxi Nicotine is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories, Inc.. The primary component is NICOTINE.
MedlinePlus Drug Summary
Nicotine lozenges are used to help people stop smoking. Nicotine lozenges are in a class of medications called smoking cessation aids. They work by providing nicotine to your body to decrease the withdrawal symptoms experienced when smoking is stopped and to reduce the urge to smoke.
Related Packages: 00536-1338-09Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Nicotine Lozenges
Product Information
| NDC | 00536-1338 |
|---|---|
| Product ID | 0536-1338_a06034db-9fc0-4ba2-a030-a57cb513f2da |
| Associated GPIs | 62100010004720 |
| GCN Sequence Number | 048775 |
| GCN Sequence Number Description | nicotine polacrilex LOZENGE 4 MG BUCCAL |
| HIC3 | J3A |
| HIC3 Description | SMOKING DETERRENT AGENTS (GANGLIONIC STIM,OTHERS) |
| GCN | 14688 |
| HICL Sequence Number | 002049 |
| HICL Sequence Number Description | NICOTINE POLACRILEX |
| Brand/Generic | Generic |
| Proprietary Name | Maxi Nicotine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | nicotine polacrilex |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOZENGE |
| Route | ORAL |
| Active Ingredient Strength | 4 |
| Active Ingredient Units | mg/1 |
| Substance Name | NICOTINE |
| Labeler Name | Rugby Laboratories, Inc. |
| Pharmaceutical Class | Cholinergic Nicotinic Agonist [EPC], Nicotine [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA209206 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00536-1338-09 (00536133809)
| NDC Package Code | 0536-1338-09 |
|---|---|
| Billing NDC | 00536133809 |
| Package | 3 BOTTLE, PLASTIC in 1 BOX (0536-1338-09) / 24 LOZENGE in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2021-09-17 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.33133 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | NICOTINE 4 MG LOZENGE |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| 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
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weekly and monthly basis