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NDC 36800-0034-14 Nicotine Transdermal System 14 mg/24h Details
Nicotine Transdermal System 14 mg/24h
Nicotine Transdermal System is a TRANSDERMAL PATCH, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is NICOTINE.
MedlinePlus Drug Summary
Nicotine skin patches are used to help people stop smoking cigarettes. They provide a source of nicotine that reduces the withdrawal symptoms experienced when smoking is stopped.
Related Packages: 36800-0034-14Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Nicotine Transdermal Patch
Product Information
| NDC | 36800-0034 |
|---|---|
| Product ID | 36800-034_0ac79685-0288-b9ba-efe6-10427cd44b45 |
| Associated GPIs | 62100005008530 |
| GCN Sequence Number | 016426 |
| GCN Sequence Number Description | nicotine PATCH TD24 14MG/24HR TRANSDERM |
| HIC3 | J3A |
| HIC3 Description | SMOKING DETERRENT AGENTS (GANGLIONIC STIM,OTHERS) |
| GCN | 03422 |
| HICL Sequence Number | 006249 |
| HICL Sequence Number Description | NICOTINE |
| Brand/Generic | Generic |
| Proprietary Name | Nicotine Transdermal System |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Nicotine Transdermal System |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | PATCH, EXTENDED RELEASE |
| Route | TRANSDERMAL |
| Active Ingredient Strength | 14 |
| Active Ingredient Units | mg/24h |
| Substance Name | NICOTINE |
| Labeler Name | Topco Associates LLC |
| Pharmaceutical Class | Cholinergic Nicotinic Agonist [EPC], Nicotine [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA074612 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 36800-0034-14 (36800003414)
| NDC Package Code | 36800-034-14 |
|---|---|
| Billing NDC | 36800003414 |
| Package | 14 POUCH in 1 CARTON (36800-034-14) / 1 h in 1 POUCH |
| Marketing Start Date | 2016-08-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |