NDC 68382-546

Memantine hydrochloride

Memantine Hydrochloride

Memantine hydrochloride is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Memantine Hydrochloride.

Product ID68382-546_02c45755-aa2c-4a58-8ace-7d39c96170e7
NDC68382-546
Product TypeHuman Prescription Drug
Proprietary NameMemantine hydrochloride
Generic NameMemantine Hydrochloride
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-04-08
Marketing CategoryANDA / ANDA
Application NumberANDA203293
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameMEMANTINE HYDROCHLORIDE
Active Ingredient Strength7 mg/1
Pharm ClassesNMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68382-546-06

30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-546-06)
Marketing Start Date2018-04-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-546-77 [68382054677]

Memantine hydrochloride CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203293
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-08

NDC 68382-546-16 [68382054616]

Memantine hydrochloride CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203293
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-08

NDC 68382-546-06 [68382054606]

Memantine hydrochloride CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203293
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-08

NDC 68382-546-30 [68382054630]

Memantine hydrochloride CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203293
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-08

Drug Details

Active Ingredients

IngredientStrength
MEMANTINE HYDROCHLORIDE7 mg/1

OpenFDA Data

SPL SET ID:eac265e6-6ea4-4368-acff-2efe6a8dd40a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 996594
  • 996609
  • 996615
  • 996603

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Memantine hydrochloride" or generic name "Memantine Hydrochloride"

    NDCBrand NameGeneric Name
    0121-0850Memantine HydrochlorideMemantine Hydrochloride
    0378-1103Memantine Hydrochloridememantine
    0378-1104Memantine Hydrochloridememantine
    0378-5435Memantine Hydrochloridememantine
    0378-5436Memantine Hydrochloridememantine
    0378-5437Memantine Hydrochloridememantine
    0378-5438Memantine Hydrochloridememantine
    0527-1221Memantine HydrochlorideMemantine Hydrochloride
    68180-246memantine hydrochloridememantine hydrochloride
    68180-229Memantine hydrochlorideMemantine hydrochloride
    68180-230Memantine hydrochlorideMemantine hydrochloride
    68180-248memantine hydrochloridememantine hydrochloride
    68180-247memantine hydrochloridememantine hydrochloride
    68180-249memantine hydrochloridememantine hydrochloride
    68382-546Memantine hydrochlorideMemantine hydrochloride
    68382-548Memantine hydrochlorideMemantine hydrochloride
    68382-388Memantine HydrochlorideMemantine Hydrochloride
    68382-389Memantine HydrochlorideMemantine Hydrochloride
    68382-547Memantine hydrochlorideMemantine hydrochloride
    68382-549Memantine hydrochlorideMemantine hydrochloride
    68788-7165Memantine HydrochlorideMemantine Hydrochloride
    0527-1222Memantine HydrochlorideMemantine Hydrochloride
    0527-1943Memantine HydrochlorideMemantine Hydrochloride
    0591-3870memantine hydrochloridememantine hydrochloride
    0591-3900memantine hydrochloridememantine hydrochloride
    0591-3875memantine hydrochloridememantine hydrochloride
    70771-1323Memantine hydrochlorideMemantine hydrochloride
    70771-1119Memantine HydrochlorideMemantine Hydrochloride
    70771-1322Memantine hydrochlorideMemantine hydrochloride
    70771-1321Memantine hydrochlorideMemantine hydrochloride
    70771-1324Memantine hydrochlorideMemantine hydrochloride
    70771-1120Memantine HydrochlorideMemantine Hydrochloride
    71335-0346Memantine HydrochlorideMemantine Hydrochloride
    71610-011memantine hydrochloridememantine hydrochloride
    72578-004Memantine HydrochlorideMemantine Hydrochloride
    72578-003Memantine HydrochlorideMemantine Hydrochloride
    0615-8264memantine hydrochloridememantine hydrochloride
    0832-1113Memantine HydrochlorideMemantine Hydrochloride
    0832-1112Memantine HydrochlorideMemantine Hydrochloride
    0904-6736memantine hydrochloridememantine hydrochloride
    0904-6735memantine hydrochloridememantine hydrochloride
    10370-347Memantine HydrochlorideMemantine Hydrochloride
    10370-348Memantine HydrochlorideMemantine Hydrochloride
    10370-349Memantine HydrochlorideMemantine Hydrochloride
    10370-346Memantine HydrochlorideMemantine Hydrochloride
    13668-222Memantine hydrochlorideMemantine hydrochloride
    13668-223Memantine hydrochlorideMemantine hydrochloride
    13668-573Memantine HydrochlorideMemantine Hydrochloride
    27241-071Memantine HydrochlorideMemantine Hydrochloride
    27241-070Memantine HydrochlorideMemantine Hydrochloride
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