NDC 68788-8965

Topiramate

Topiramate

Topiramate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals. The primary component is Topiramate.

• Product ID: 68788-8965_8089b149-0ab7-4195-abcd-540c6b50e178
• NDC: 68788-8965
• Product Type: Human Prescription Drug
• Proprietary Name: Topiramate
• Generic Name: Topiramate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2016-01-04
• Marketing Category: ANDA / ANDA
• Application Number: ANDA079162
• Labeler Name: Preferred Pharmaceuticals
• Substance Name: TOPIRAMATE
• Active Ingredient Strength: 25 mg/1
• Pharm Classes: Decreased Centr
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 68788-8965-3

30 TABLET in 1 BOTTLE (68788-8965-3)

• Marketing Start Date: 2016-01-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68788-8965-5 [68788896505]

Topiramate TABLET

• Marketing Category: ANDA
• Application Number: ANDA079162
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-01-04
• Marketing End Date: 2019-04-05

NDC 68788-8965-6 [68788896506]

Topiramate TABLET

• Marketing Category: ANDA
• Application Number: ANDA079162
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-01-04
• Marketing End Date: 2019-04-05

NDC 68788-8965-3 [68788896503]

Topiramate TABLET

• Marketing Category: ANDA
• Application Number: ANDA079162
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-01-04
• Marketing End Date: 2019-04-05

NDC 68788-8965-9 [68788896509]

Topiramate TABLET

• Marketing Category: ANDA
• Application Number: ANDA079162
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-01-04
• Marketing End Date: 2019-04-05

Drug Details

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 "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