NDC 68071-4756

topiramate

Topiramate

topiramate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Nucare Pharmaceuticals,inc.. The primary component is Topiramate.

• Product ID: 68071-4756_835d8745-b43d-55ad-e053-2a91aa0a05fe
• NDC: 68071-4756
• Product Type: Human Prescription Drug
• Proprietary Name: topiramate
• Generic Name: Topiramate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2009-03-27
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078235
• Labeler Name: NuCare Pharmaceuticals,Inc.
• Substance Name: TOPIRAMATE
• Active Ingredient Strength: 50 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 68071-4756-3

30 TABLET, FILM COATED in 1 BOTTLE (68071-4756-3)

• Marketing Start Date: 2019-02-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68071-4756-3 [68071475603]

topiramate TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA078235
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-02-06

Drug Details

Active Ingredients

Ingredient	Strength
TOPIRAMATE	50 mg/1

OpenFDA Data

• SPL SET ID: 813cc96c-5598-1ffd-e053-2991aa0ae9bd
• Manufacturer:
  • NuCare Pharmaceuticals,Inc.
• UNII:
  • 0H73WJJ391
• RxNorm Concept Unique ID - RxCUI:
  • 151226
• UPC Code:
  • 0368071475661

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