NDC 68820-068

Mematine Hydrochloride

Mematine Hydrochloride

Mematine Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Orchid Chemicals & Pharmaceuticals Limited. The primary component is Memantine Hydrochloride.

Product ID68820-068_217a3119-7c11-4d37-80d9-e331947c7d5b
NDC68820-068
Product TypeHuman Prescription Drug
Proprietary NameMematine Hydrochloride
Generic NameMematine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-01-11
Marketing CategoryANDA / ANDA
Application NumberANDA090044
Labeler NameOrchid Chemicals & Pharmaceuticals Limited
Substance NameMEMANTINE HYDROCHLORIDE
Active Ingredient Strength5 mg/1
Pharm ClassesNMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68820-068-12

500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68820-068-12)
Marketing Start Date2015-01-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68820-068-12 [68820006812]

Mematine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090044
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-11
Marketing End Date2015-01-11

NDC 68820-068-09 [68820006809]

Mematine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090044
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-11
Marketing End Date2015-01-11

NDC 68820-068-03 [68820006803]

Mematine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090044
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-11
Marketing End Date2015-01-11

NDC 68820-068-11 [68820006811]

Mematine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090044
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-11
Marketing End Date2015-01-11

Drug Details

Active Ingredients

IngredientStrength
MEMANTINE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:c65fe60f-8daa-4c77-b072-b3d8540baf38
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 996561
  • 996571

    • Pharmacological Class

    • NMDA Receptor Antagonists [MoA]
    • N-methyl-D-aspartate Receptor Antagonist [EPC]

    NDC Crossover Matching brand name "Mematine Hydrochloride" or generic name "Mematine Hydrochloride"

    NDCBrand NameGeneric Name
    68820-068Mematine HydrochlorideMematine Hydrochloride
    68820-069Mematine HydrochlorideMematine Hydrochloride
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