Home NDC 50090-0020-3 Amantadine Hydrochloride
Product NDC 50090-0020
Requested package NDC 50090-0020-3
11-digit product format 500900020
Labeler code 50090
Product ID 50090-0020_26781687-0a06-4c40-98bb-618bc0d584dc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amantadine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler A-S Medication Solutions
Application ANDA071293
Marketing category ANDA
Marketing start 1987-02-18
Substance AMANTADINE HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071293-001 AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A071293-001 AB
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 2 · 42 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 2026-08-18 06:07:40 2026-07 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 1987-02-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 1987-02-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 1987-02-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB RS 1987-02-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A071293-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1987-02-18 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Amantadine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMANTADINE HYDROCHLORIDE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination M6Q1EO9TD0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 849389 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-0020-0 Amantadine Hydrochloride 16 in 1 BOTTLE CAPSULE 16 8 50090-0020-3 Amantadine Hydrochloride 10 in 1 BOTTLE CAPSULE 10 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-0020 AMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS] 6 Current NDC, Legacy NDC, 2 package rows 20190225_da693bb0-0cc8-485d-89a7-c8cf28d440f3.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-0020-3 50090002003 10 CAPSULE in 1 BOTTLE (50090-0020-3) 10 capsule 2014-11-28 No No Current