NDC 21695-130

Topamax

Topiramate

Topamax is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Topiramate.

• Product ID: 21695-130_202b1a2a-11dc-4c3d-aa53-27512a98a042
• NDC: 21695-130
• Product Type: Human Prescription Drug
• Proprietary Name: Topamax
• Generic Name: Topiramate
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 1997-01-01
• Marketing Category: NDA / NDA
• Application Number: NDA020505
• Labeler Name: Rebel Distributors Corp
• 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: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 21695-130-15

15 TABLET, COATED in 1 BOTTLE (21695-130-15)

• Marketing Start Date: 1997-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 21695-130-15 [21695013015]

Topamax TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA020505
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1997-01-01
• Inactivation Date: 2019-09-24

Drug Details

Active Ingredients

Ingredient	Strength
TOPIRAMATE	100 mg/1

OpenFDA Data

• SPL SET ID: 202b1a2a-11dc-4c3d-aa53-27512a98a042
• Manufacturer:
  • Rebel Distributors Corp
• UNII:
  • 0H73WJJ391
• RxNorm Concept Unique ID - RxCUI:
  • 199889
  • 199888
  • 152855
  • 151228
  • 151227
  • 151226

Pharmacological Class

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

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