qsymia

Generic: phentermine and topiramate

Labeler: vivus llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name qsymia
Generic Name phentermine and topiramate
Labeler vivus llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

phentermine hydrochloride 3.75 mg/1, topiramate 23 mg/1

Manufacturer
Vivus LLC

Identifiers & Regulatory

Product NDC 62541-201
Product ID 62541-201_3e4dec6d-5fe5-ec19-e063-6394a90a35d6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022580
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2012-09-17

Pharmacologic Class

Mechanism of Action
cytochrome p450 3a4 inducers [moa] cytochrome p450 2c19 inhibitors [moa]
Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62541201
Hyphenated Format 62541-201

Supplemental Identifiers

RxCUI
1302827 1302833 1302839 1302845 1302850 1302856 1313059 1313061
UPC
0362541202306 0362541203303 0362541204300 0362541201309
UNII
0K2I505OTV 0H73WJJ391
NUI
N0000008486 N0000185506 N0000182140

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name qsymia (source: ndc)
Generic Name phentermine and topiramate (source: ndc)
Application Number NDA022580 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3.75 mg/1
  • 23 mg/1
source: ndc
Packaging
  • 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (62541-201-14)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (62541-201-30)
source: ndc

Packages (2)

62541-201-14 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (62541-201-14) 62541-201-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (62541-201-30)

Ingredients (2)

phentermine hydrochloride (3.75 mg/1) topiramate (23 mg/1)

Linked Drug Pages (1)

Qsymia ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3e4dec6d-5fe5-ec19-e063-6394a90a35d6", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0362541202306", "0362541203303", "0362541204300", "0362541201309"], "unii": ["0K2I505OTV", "0H73WJJ391"], "rxcui": ["1302827", "1302833", "1302839", "1302845", "1302850", "1302856", "1313059", "1313061"], "spl_set_id": ["40dd5602-53da-45ac-bb4b-15789aba40f9"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_moa": ["Cytochrome P450 3A4 Inducers [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Vivus LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (62541-201-14)", "package_ndc": "62541-201-14", "marketing_start_date": "20120917"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (62541-201-30)", "package_ndc": "62541-201-30", "marketing_start_date": "20120917"}], "brand_name": "Qsymia", "product_id": "62541-201_3e4dec6d-5fe5-ec19-e063-6394a90a35d6", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_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]"], "product_ndc": "62541-201", "dea_schedule": "CIV", "generic_name": "phentermine and topiramate", "labeler_name": "Vivus LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Qsymia", "active_ingredients": [{"name": "PHENTERMINE HYDROCHLORIDE", "strength": "3.75 mg/1"}, {"name": "TOPIRAMATE", "strength": "23 mg/1"}], "application_number": "NDA022580", "marketing_category": "NDA", "marketing_start_date": "20120917", "listing_expiration_date": "20261231"}