NDC 0093-7335

Topiramate

Topiramate

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

• Product ID: 0093-7335_92ef1d24-c0ca-46d2-87a5-73e2134732a6
• NDC: 0093-7335
• Product Type: Human Prescription Drug
• Proprietary Name: Topiramate
• Generic Name: Topiramate
• Dosage Form: Capsule, Coated Pellets
• Route of Administration: ORAL
• Marketing Start Date: 2009-04-17
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076575
• Labeler Name: Teva Pharmaceuticals USA, 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: 2022-12-31

Packaging

NDC 0093-7335-06

60 CAPSULE, COATED PELLETS in 1 BOTTLE (0093-7335-06)

• Marketing Start Date: 2009-04-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0093-7335-06 [00093733506]

Topiramate CAPSULE, COATED PELLETS

• Marketing Category: ANDA
• Application Number: ANDA076575
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-04-17

Drug Details

Active Ingredients

Ingredient	Strength
TOPIRAMATE	15 mg/1

OpenFDA Data

• SPL SET ID: 1f5f940c-d5b9-4d09-958d-246931e167af
• Manufacturer:
  • Teva Pharmaceuticals USA, Inc.
• UNII:
  • 0H73WJJ391
• RxNorm Concept Unique ID - RxCUI:
  • 205316
  • 205315
• UPC Code:
  • 0300937336068

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
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
68071-3012	Topiramate	Topiramate
68071-3088	Topiramate	Topiramate
68071-3196	Topiramate	Topiramate
68071-1960	Topiramate	Topiramate
68071-1971	Topiramate	Topiramate
68071-1900	Topiramate	Topiramate
68071-4793	topiramate	topiramate
68071-4760	topiramate	topiramate
68084-344	Topiramate	Topiramate
68084-342	Topiramate	Topiramate
68071-4756	topiramate	topiramate
68084-345	Topiramate	Topiramate
68258-7159	TOPIRAMATE	TOPIRAMATE
68382-138	topiramate	topiramate
68382-004	topiramate	topiramate
68258-3000	TOPIRAMATE	TOPIRAMATE
68258-3002	TOPIRAMATE	TOPIRAMATE
68258-3001	TOPIRAMATE	TOPIRAMATE
68382-139	topiramate	topiramate
68258-7056	TOPIRAMATE	TOPIRAMATE
68382-140	topiramate	topiramate
68382-005	topiramate	topiramate
68258-7156	TOPIRAMATE	TOPIRAMATE
68382-141	topiramate	topiramate
68382-769	Topiramate	Topiramate
68382-864	Topiramate	Topiramate
68387-559	Topiramate	Topiramate
68387-558	Topiramate	Topiramate
68387-560	Topiramate	Topiramate
68382-863	Topiramate	Topiramate
68462-109	Topiramate	Topiramate
68462-110	Topiramate	Topiramate
68462-108	Topiramate	Topiramate
68462-153	Topiramate	Topiramate
68788-6435	Topiramate	Topiramate
68788-7016	Topiramate	Topiramate
68788-6377	Topiramate	Topiramate
68788-6770	Topiramate	Topiramate
68788-7351	topiramate	topiramate
68788-8965	Topiramate	Topiramate
68788-6366	Topiramate	Topiramate
68788-6916	Topiramate	Topiramate