NDC 12634-083

Topiramate

Topiramate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Apotheca Inc.. The primary component is Topiramate.

Product ID	12634-083_35bd4587-6e8b-13a1-e054-00144ff88e88
NDC	12634-083
Product Type	Human Prescription Drug
Proprietary Name	Topiramate
Generic Name	Topiramate
Dosage Form	Tablet, Film Coated
Route of Administration	ORAL
Marketing Start Date	2014-12-15
Marketing Category	ANDA / ANDA
Application Number	ANDA090278
Labeler Name	Apotheca Inc.
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	N
Listing Certified Through	2019-12-31

Packaging

NDC 12634-083-00

10 TABLET, FILM COATED in 1 BOTTLE (12634-083-00)

Marketing Start Date	2014-12-15
NDC Exclude Flag	N
Sample Package?	N

NDC SPL Data Element Entries

NDC 12634-083-42 [12634008342]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-96 [12634008396]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-97 [12634008397]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-81 [12634008381]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-90 [12634008390]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-84 [12634008384]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-78 [12634008378]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-85 [12634008385]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-95 [12634008395]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-80 [12634008380]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-71 [12634008371]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Billing Unit	EA
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-09 [12634008309]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-45 [12634008345]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-40 [12634008340]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-50 [12634008350]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-63 [12634008363]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-92 [12634008392]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-91 [12634008391]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-59 [12634008359]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-66 [12634008366]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-00 [12634008300]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-60 [12634008360]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-54 [12634008354]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-57 [12634008357]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-52 [12634008352]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-69 [12634008369]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-98 [12634008398]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-67 [12634008367]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-74 [12634008374]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-99 [12634008399]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-93 [12634008393]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-01 [12634008301]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-94 [12634008394]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-79 [12634008379]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-61 [12634008361]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

NDC 12634-083-82 [12634008382]

Topiramate TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA090278
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2014-12-15
Inactivation Date	2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
TOPIRAMATE	100 mg/1

OpenFDA Data

SPL SET ID:	35bd4587-6e8a-13a1-e054-00144ff88e88
Manufacturer	Apotheca Inc.
UNII	0H73WJJ391
RxNorm Concept Unique ID - RxCUI	199889

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