Home NDC 71335-1863-3 Memantine Hydrochloride
Product NDC 71335-1863
Requested package NDC 71335-1863-3
11-digit product format 713351863
Labeler code 71335
Product ID 71335-1863_9dddccbd-8e8d-4128-99f4-a31193b44a18
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Memantine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA090073
Marketing category ANDA
Marketing start 2020-06-05
Marketing end 0000-00-00
Substance MEMANTINE HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71335-1863 71335-1863-3 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71335-1863 71335-1863-3 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090073-001 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2015-09-04 A090073-002 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2015-09-04
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.
Product history page 1 of 3 · 82 observed 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 2026-02-19 14:30 UTC 2026-02 A090073-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2015-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090073-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2015-09-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090073-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2015-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090073-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2015-09-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090073-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2015-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090073-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2015-09-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090073-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2015-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090073-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2015-09-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090073-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2015-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090073-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2015-09-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090073-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2015-09-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090073-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2015-09-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090073-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2015-09-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090073-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2015-09-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090073-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090073-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090073-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090073-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090073-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090073-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090073-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090073-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090073-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090073-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090073-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090073-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090073-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-04 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090073-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090073-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-04 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090073-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090073-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-04 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090073-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090073-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-04 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090073-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090073-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-04 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090073-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090073-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-04 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090073-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090073-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-04 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A090073-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-04 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-1863-1 Memantine Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 100 71335-1863-2 Memantine Hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 100 71335-1863-3 Memantine Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 100 71335-1863-4 Memantine Hydrochloride 180 in 1 BOTTLE TABLET, FILM COATED 180 100
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1863 MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 100 Legacy NDC, 4 package rows 20211023_6ba63a8d-4cbe-45b8-b6cf-675557a8f6e0.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71335-1863-3 71335186303 90 TABLET, FILM COATED in 1 BOTTLE (71335-1863-3) 2021-10-21 0000-00-00 No No Current