NDC 62541-204

Qsymia

Phentermine And Topiramate

Qsymia is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Vivus, Inc.. The primary component is Phentermine Hydrochloride; Topiramate.

• Product ID: 62541-204_7abbdebd-dd3f-53ba-e053-2a91aa0adbbf
• NDC: 62541-204
• Product Type: Human Prescription Drug
• Proprietary Name: Qsymia
• Generic Name: Phentermine And Topiramate
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2012-09-17
• Marketing Category: NDA / NDA
• Application Number: NDA022580
• Labeler Name: Vivus, Inc.
• Substance Name: PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
• Active Ingredient Strength: 15 mg/1; mg/1
• Pharm Classes: Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
• DEA Schedule: CIV
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 62541-204-30

30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (62541-204-30)

• Marketing Start Date: 2012-09-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 62541-204-30 [62541020430]

Qsymia CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA022580
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-09-17

Drug Details

Active Ingredients

Ingredient	Strength
PHENTERMINE HYDROCHLORIDE	15 mg/1

OpenFDA Data

• SPL SET ID: 40dd5602-53da-45ac-bb4b-15789aba40f9
• Manufacturer:
  • Vivus, Inc.
• UNII:
  • 0H73WJJ391
  • 0K2I505OTV
• RxNorm Concept Unique ID - RxCUI:
  • 1313061
  • 1302839
  • 1302827
  • 1302833
  • 1313059
  • 1302845
  • 1302850
  • 1302856

Pharmacological Class

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

Medicade Reported Pricing

62541020430 QSYMIA 15 MG-92 MG CAPSULE

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Qsymia" or generic name "Phentermine And Topiramate"

NDC	Brand Name	Generic Name
62541-201	Qsymia	phentermine and topiramate
62541-202	Qsymia	phentermine and topiramate
62541-203	Qsymia	phentermine and topiramate
62541-204	Qsymia	phentermine and topiramate