Home NDC 60505-6211-9 Memantine Hydrochloride
Product NDC 60505-6211
Requested package NDC 60505-6211-9
11-digit product format 605056211
Labeler code 60505
Product ID 60505-6211_6cfcef62-aadf-4c12-9fa7-2e8cb65f8d54
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name memantine hydrochloride
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Apotex Corp
Application NDA022525
Marketing category NDA
Marketing start 2019-05-09
Marketing end 0000-00-00
Substance MEMANTINE HYDROCHLORIDE
Active strength 28 mg/1
Pharmacologic classes N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022525-001 NAMENDA XR MEMANTINE HYDROCHLORIDE 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, EXTENDED RELEASE / ORAL RLD 2010-06-21 N022525-002 NAMENDA XR MEMANTINE HYDROCHLORIDE 14MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, EXTENDED RELEASE / ORAL RLD 2010-06-21 N022525-003 NAMENDA XR MEMANTINE HYDROCHLORIDE 21MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, EXTENDED RELEASE / ORAL RLD 2010-06-21 N022525-004 NAMENDA XR MEMANTINE HYDROCHLORIDE 28MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, EXTENDED RELEASE / ORAL RLD 2010-06-21
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022525-001 8039009 2029-03-24 U-539 2011-11-16 N022525-001 8039009*PED 2029-09-24 Pediatric extension N022525-002 8039009 2029-03-24 U-539 N022525-002 8039009*PED 2029-09-24 Pediatric extension N022525-003 8039009 2029-03-24 U-539 N022525-003 8039009*PED 2029-09-24 Pediatric extension N022525-004 8039009 2029-03-24 U-539 N022525-004 8039009*PED 2029-09-24 Pediatric extension
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N022525-001 NAMENDA XR 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, EXTENDED RELEASE / ORAL RLD 2010-06-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N022525-002 NAMENDA XR 14MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, EXTENDED RELEASE / ORAL RLD 2010-06-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N022525-003 NAMENDA XR 21MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, EXTENDED RELEASE / ORAL RLD 2010-06-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N022525-004 NAMENDA XR 28MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, EXTENDED RELEASE / ORAL RLD 2010-06-21 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N022525-001 8039009 2029-03-24 U-539 2011-11-16 a50c72e98297…2026-08-01 22:54:32 2026-06 N022525-001 8039009*PED 2029-09-24 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022525-002 8039009 2029-03-24 U-539 a50c72e98297…2026-08-01 22:54:32 2026-06 N022525-002 8039009*PED 2029-09-24 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022525-003 8039009 2029-03-24 U-539 a50c72e98297…2026-08-01 22:54:32 2026-06 N022525-003 8039009*PED 2029-09-24 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022525-004 8039009 2029-03-24 U-539 a50c72e98297…2026-08-01 22:54:32 2026-06 N022525-004 8039009*PED 2029-09-24 Pediatric extension a50c72e98297…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60505-6211-9 60505621109 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-6211-9) 2019-05-09 0000-00-00 No No Current