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NDC 00135-0626-01 NICORETTE 4 mg/1 Details
NICORETTE 4 mg/1
NICORETTE is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. 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: 00135-0626-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Nicotine Lozenges
Product Information
| NDC | 00135-0626 |
|---|---|
| Product ID | 0135-0626_1dc126d5-ca50-43b7-97d7-4d4f30b7c7cd |
| 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 | Brand |
| Proprietary Name | NICORETTE |
| 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 | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| Pharmaceutical Class | Cholinergic Nicotinic Agonist [EPC], Nicotine [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA021330 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00135-0626-01 (00135062601)
| NDC Package Code | 0135-0626-01 |
|---|---|
| Billing NDC | 00135062601 |
| Package | 1 CONTAINER in 1 CARTON (0135-0626-01) / 20 LOZENGE in 1 CONTAINER |
| Marketing Start Date | 2019-04-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |