NDC 70771-1316

Topiramate

Topiramate

Topiramate is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Cadila Healthcare Limited. The primary component is Topiramate.

Product ID70771-1316_1c0fbf5e-aed6-4cc9-bfc5-ade8b985553e
NDC70771-1316
Product TypeHuman Prescription Drug
Proprietary NameTopiramate
Generic NameTopiramate
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-04-05
Marketing CategoryANDA / ANDA
Application NumberANDA207382
Labeler NameCadila Healthcare Limited
Substance NameTOPIRAMATE
Active Ingredient Strength50 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 70771-1316-1

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1316-1)
Marketing Start Date2018-04-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70771-1316-2 [70771131602]

Topiramate CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207382
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-05

NDC 70771-1316-5 [70771131605]

Topiramate CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207382
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-05

NDC 70771-1316-3 [70771131603]

Topiramate CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207382
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-05

NDC 70771-1316-1 [70771131601]

Topiramate CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207382
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-05

NDC 70771-1316-9 [70771131609]

Topiramate CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207382
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-05

NDC 70771-1316-4 [70771131604]

Topiramate CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207382
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-05

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"

NDCBrand NameGeneric Name
0093-7335TopiramateTopiramate
0093-7336TopiramateTopiramate
0615-7562TopiramateTopiramate
0615-7563TopiramateTopiramate
0615-7564TopiramateTopiramate
0615-7565TopiramateTopiramate
0615-8138TopiramateTopiramate
0615-8139TopiramateTopiramate
68071-3012TopiramateTopiramate
68071-3088TopiramateTopiramate
68071-3196TopiramateTopiramate
68071-1960TopiramateTopiramate
68071-1971TopiramateTopiramate
68071-1900TopiramateTopiramate
68071-4793topiramatetopiramate
68071-4760topiramatetopiramate
68084-344TopiramateTopiramate
68084-342TopiramateTopiramate
68071-4756topiramatetopiramate
68084-345TopiramateTopiramate
68258-7159TOPIRAMATETOPIRAMATE
68382-138topiramatetopiramate
68382-004topiramatetopiramate
68258-3000TOPIRAMATETOPIRAMATE
68258-3002TOPIRAMATETOPIRAMATE
68258-3001TOPIRAMATETOPIRAMATE
68382-139topiramatetopiramate
68258-7056TOPIRAMATETOPIRAMATE
68382-140topiramatetopiramate
68382-005topiramatetopiramate
68258-7156TOPIRAMATETOPIRAMATE
68382-141topiramatetopiramate
68382-769TopiramateTopiramate
68382-864TopiramateTopiramate
68387-559TopiramateTopiramate
68387-558TopiramateTopiramate
68387-560TopiramateTopiramate
68382-863TopiramateTopiramate
68462-109TopiramateTopiramate
68462-110TopiramateTopiramate
68462-108TopiramateTopiramate
68462-153TopiramateTopiramate
68788-6435TopiramateTopiramate
68788-7016TopiramateTopiramate
68788-6377TopiramateTopiramate
68788-6770TopiramateTopiramate
68788-7351topiramatetopiramate
68788-8965TopiramateTopiramate
68788-6366TopiramateTopiramate
68788-6916TopiramateTopiramate

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