NDC 50458-647

Topamax

Topiramate

Topamax is a Oral Capsule, Coated Pellets in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Topiramate.

• Product ID: 50458-647_007c7ba9-3103-4238-9524-a9421607912d
• NDC: 50458-647
• Product Type: Human Prescription Drug
• Proprietary Name: Topamax
• Generic Name: Topiramate
• Dosage Form: Capsule, Coated Pellets
• Route of Administration: ORAL
• Marketing Start Date: 1998-11-01
• Marketing Category: NDA / NDA
• Application Number: NDA020844
• Labeler Name: Janssen Pharmaceuticals, Inc.
• Substance Name: TOPIRAMATE
• Active Ingredient Strength: 15 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 50458-647-65

60 CAPSULE, COATED PELLETS in 1 BOTTLE (50458-647-65)

• Marketing Start Date: 1998-11-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50458-647-65 [50458064765]

Topamax CAPSULE, COATED PELLETS

• Marketing Category: NDA
• Application Number: NDA020844
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-11-01

Drug Details

Active Ingredients

Ingredient	Strength
TOPIRAMATE	15 mg/1

OpenFDA Data

• SPL SET ID: 21628112-0c47-11df-95b3-498d55d89593
• Manufacturer:
  • Janssen Pharmaceuticals, Inc.
• UNII:
  • 0H73WJJ391
• RxNorm Concept Unique ID - RxCUI:
  • 199889
  • 199888
  • 152855
  • 845478
  • 845479
  • 199890
  • 205316
  • 151229
  • 151228
  • 151227
  • 151226
  • 205315
• UPC Code:
  • 0350458639650
  • 0350458640656
  • 0350458645651
  • 0350458641653
  • 0350458647655
  • 0350458642650

Pharmacological Class

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

Medicade Reported Pricing

50458064765 TOPAMAX 15 MG SPRINKLE CAP

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Topamax" or generic name "Topiramate"

NDC	Brand Name	Generic Name
70518-1393	Topamax	Topamax
21695-128	Topamax	Topamax
21695-130	Topamax	Topamax
21695-129	Topamax	Topamax
50458-647	Topamax	Topamax
50458-645	Topamax	Topamax
50458-642	Topamax	Topamax
50458-641	Topamax	Topamax
50458-639	Topamax	Topamax
50458-640	Topamax	Topamax
55289-433	Topamax	Topamax
61919-189	TOPAMAX	TOPAMAX
70518-2165	Topamax	Topamax
70518-2753	Topamax	Topamax
80425-0092	Topamax	Topamax
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