FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
0121-0850
11-digit product format
001210850
Labeler code
0121
Product ID
0121-0850_ed854db7-e85c-fb08-e053-2a95a90aaf92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA204033
Marketing category
ANDA
Marketing start
2019-04-15
Marketing end
2024-05-31
Substance
MEMANTINE HYDROCHLORIDE
Active strength
10 mg/5mL
Pharmacologic classes
N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0121-0850DDiscontinued by firm2026-08-03
excluded packagepackage0121-08500121-0850-40DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204033-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE2MG/MLSOLUTION / ORALAARS2015-10-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A204033-001AA

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A204033-001MEMANTINE HYDROCHLORIDE2MG/MLSOLUTION / ORALAARS2015-10-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204033-001AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEChartwell Governmental & Specialty RX, LLC.d1f97615-e888-421e-b50a-95a87a1965ff2026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204033
application number: ANDA204033
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEChartwell RX, LLCa7b76864-6de7-45f6-be5b-5ecfca8116272026-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204033
application number: ANDA204033

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0121-0850-402022-11-15C16284748780-1d6a99b39-848f-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use Memantine Hydrochloride Oral Solution safely and effectively. See full prescribing information for Memantine Hydrochloride Oral Solution. Memantine Hydrochloride Oral Solution, for oral use Initial U.S. Approval: 2003
0121-0850-402022-01-28C16284748780-1d6a99b39-848f-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use Memantine Hydrochloride Oral Solution safely and effectively. See full prescribing information for Memantine Hydrochloride Oral Solution. Memantine Hydrochloride Oral Solution, for oral use Initial U.S. Approval: 2003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0850-05ML - Milliliter0121-085048051d3b-0536-4bb2-a91a-7688e6918d9512019-09-05
0121-0850-40ML - Milliliter0121-085070ee6438-817f-4f8a-94ec-f0c87dd10c8312019-09-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0850-40001210850404 TRAY in 1 CASE (0121-0850-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0850-05) 4 tray2019-04-150000-00-00NoNoCurrent