NDC 0121-0850

Memantine Hydrochloride

Memantine Hydrochloride

Memantine Hydrochloride is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Pharmaceutical Associates, Inc.. The primary component is Memantine Hydrochloride.

Product ID0121-0850_88655950-990f-1b76-e053-2995a90a1b9b
NDC0121-0850
Product TypeHuman Prescription Drug
Proprietary NameMemantine Hydrochloride
Generic NameMemantine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2019-04-15
Marketing CategoryANDA / ANDA
Application NumberANDA204033
Labeler NamePharmaceutical Associates, Inc.
Substance NameMEMANTINE HYDROCHLORIDE
Active Ingredient Strength10 mg/5mL
Pharm ClassesNMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0121-0850-40

4 TRAY in 1 CASE (0121-0850-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0850-05)
Marketing Start Date2019-04-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0121-0850-05 [00121085005]

Memantine Hydrochloride SOLUTION
Marketing CategoryANDA
Application NumberANDA204033
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-04-15

NDC 0121-0850-40 [00121085040]

Memantine Hydrochloride SOLUTION
Marketing CategoryANDA
Application NumberANDA204033
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-04-15

Drug Details

Active Ingredients

IngredientStrength
MEMANTINE HYDROCHLORIDE10 mg/5mL

Pharmacological Class

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.