62541-201 NDC - QSYMIA (PHENTERMINE AND TOPIRAMATE)

Drug Information

Product NDC: 62541-201

Proprietary Name: Qsymia

Non Proprietary Name: phentermine and topiramate

Active Ingredient(s):
  • 3.75 mg/1 PHENTERMINE HYDROCHLORIDE;
  • 23 mg/1 TOPIRAMATE


Administration Route(s): ORAL

Dosage Form(s): CAPSULE, EXTENDED RELEASE

Pharmacy Class(es):
  • Appetite Suppression [PE];
  • Increased Sympathetic Activity [PE];
  • Sympathomimetic Amine Anorectic [EPC];
  • Decreased Central Nervous System Disorganized Electrical Activity [PE];
  • Cytochrome P450 3A4 Inducers [MoA];
  • Cytochrome P450 2C19 Inhibitors [MoA]

Labeler Information

Labeler Name: Vivus, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA022580
Marketing Category: NDA
Start Marketing Date:9/17/2012
DEA Schedule:CIV

Package Information

No. Package Code Package Description Billing Unit
162541-201-1414 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (62541-201-14)
262541-201-3030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (62541-201-30)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC62541-201The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEQsymiaThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEphentermine and topiramateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECAPSULE, EXTENDED RELEASEThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE9/17/2012This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA022580This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEVivus, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEPHENTERMINE HYDROCHLORIDE; TOPIRAMATEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH3.75; 23 
ACTIVE INGRED UNITmg/1; mg/1 
PHARM CLASSESAppetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 
DEA SCHEDULECIVThis is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

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This page was last updated on: 7/15/2019