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NDC 62541-0201-14 Qsymia 3.75; 23 mg/1; mg/1 Details
Qsymia 3.75; 23 mg/1; mg/1
Qsymia is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Vivus LLC. The primary component is PHENTERMINE HYDROCHLORIDE; TOPIRAMATE.
MedlinePlus Drug Summary
Phentermine and topiramate extended-release (long-acting) capsules are used to help adults who are obese or who are overweight and have weight-related medical problems to lose weight and to keep from gaining back that weight. Phentermine and topiramate extended-release (long-acting) capsules are also used to help children aged 12 years or older who have a body mass index (BMI) in the 95th percentile or greater based on age and sex standards. Phentermine and topiramate extended-release capsules must be used along with a reduced calorie diet and exercise plan. Phentermine is in a class of medications called anorectics. It works by decreasing appetite. Topiramate is in a class of medications called anticonvulsants. It works by decreasing appetite and by causing feelings of fullness to last longer after eating.
Related Packages: 62541-0201-14Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phentermine and Topiramate
Product Information
| NDC | 62541-0201 |
|---|---|
| Product ID | 62541-201_0c404c87-1228-4c9f-e063-6294a90aad84 |
| Associated GPIs | 61209902307020 |
| GCN Sequence Number | 069617 |
| GCN Sequence Number Description | phentermine/topiramate CPMP 24HR 3.75-23 MG ORAL |
| HIC3 | J8A |
| HIC3 Description | ANTI-OBESITY - ANOREXIC AGENTS |
| GCN | 32515 |
| HICL Sequence Number | 039347 |
| HICL Sequence Number Description | PHENTERMINE HCL/TOPIRAMATE |
| Brand/Generic | Brand |
| Proprietary Name | Qsymia |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | phentermine and topiramate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 3.75; 23 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE |
| Labeler Name | Vivus LLC |
| Pharmaceutical Class | Appetite Suppression [PE], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC] |
| DEA Schedule | CIV |
| Marketing Category | NDA |
| Application Number | NDA022580 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 62541-0201-14 (62541020114)
| NDC Package Code | 62541-201-14 |
|---|---|
| Billing NDC | 62541020114 |
| Package | 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (62541-201-14) |
| Marketing Start Date | 2012-09-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |