NDC 17772-103

Trokendi XR

Topiramate

Trokendi XR is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Supernus Pharmaceuticals. The primary component is Topiramate.

• Product ID: 17772-103_849fe8c8-6088-77c3-e053-2a91aa0ad729
• NDC: 17772-103
• Product Type: Human Prescription Drug
• Proprietary Name: Trokendi XR
• Generic Name: Topiramate
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2013-08-16
• Marketing Category: NDA / NDA
• Application Number: NDA201635
• Labeler Name: Supernus Pharmaceuticals
• Substance Name: TOPIRAMATE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 17772-103-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-103-01)

• Marketing Start Date: 2013-08-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 17772-103-12 [17772010312]

Trokendi XR CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA201635
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-08-16

NDC 17772-103-10 [17772010310]

Trokendi XR CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA201635
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-08-16

NDC 17772-103-03 [17772010303]

Trokendi XR CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA201635
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-08-16
• Marketing End Date: 2019-03-21

NDC 17772-103-30 [17772010330]

Trokendi XR CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA201635
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-08-16

NDC 17772-103-01 [17772010301]

Trokendi XR CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA201635
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-08-16

NDC 17772-103-15 [17772010315]

Trokendi XR CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA201635
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-08-16
• Marketing End Date: 2017-11-17

Drug Details

Active Ingredients

Ingredient	Strength
TOPIRAMATE	100 mg/1

OpenFDA Data

• SPL SET ID: 2dc7957e-a3e5-46bb-aa66-f3250f872f5e
• Manufacturer:
  • Supernus Pharmaceuticals
• UNII:
  • 0H73WJJ391
• RxNorm Concept Unique ID - RxCUI:
  • 1436239
  • 1437288
  • 1436245
  • 1437283
  • 1437280
  • 1437278
  • 1437290
  • 1437285

Pharmacological Class

• Decreased Central Nervous System Disorganized Electrical Activity [PE]
• Cytochrome P450 3A4 Inducers [MoA]
• Cytochrome P450 2C19 Inhibitors [MoA]

Medicade Reported Pricing

17772010330 TROKENDI XR 100 MG CAPSULE

Pricing Unit: EA | Drug Type:

17772010315 TROKENDI XR 100 MG CAPSULE

Pricing Unit: EA | Drug Type:

17772010301 TROKENDI XR 100 MG CAPSULE

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Trokendi XR" or generic name "Topiramate"

NDC	Brand Name	Generic Name
17772-104	Trokendi XR	Trokendi XR
17772-103	Trokendi XR	Trokendi XR
17772-102	Trokendi XR	Trokendi XR
17772-101	Trokendi XR	Trokendi XR
0245-1071	QUDEXY	Topiramate
0245-1072	QUDEXY	Topiramate
0245-1073	QUDEXY	Topiramate
0245-1074	QUDEXY	Topiramate
0245-1075	QUDEXY	Topiramate
0093-7335	Topiramate	Topiramate
0093-7336	Topiramate	Topiramate
0615-7562	Topiramate	Topiramate
0615-7563	Topiramate	Topiramate
0615-7564	Topiramate	Topiramate
0615-7565	Topiramate	Topiramate
0615-8138	Topiramate	Topiramate
0615-8139	Topiramate	Topiramate