Home NDC 64380-862 Amantadine Hydrochloride
Product NDC 64380-862
11-digit product format 643800862
Labeler code 64380
Product ID 64380-862_cd49441d-853e-4400-90bb-8e9e81d96b9f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amantadine Hydrochloride
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA211354
Marketing category ANDA
Marketing start 2022-12-01
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 2026-12-31
Current FDA listing Yes 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 A211354-001 AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211354-001 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.
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 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 4b0b4de00fa7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL 2022-02-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL 2022-02-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL 2022-02-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211354-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 2022-02-18 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Amantadine Hydrochloride
Listing expiration 2026-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64380-862-06 Amantadine Hydrochloride 100 in 1 BOTTLE CAPSULE, LIQUID FILLED 100 7 64380-862-07 Amantadine Hydrochloride 500 in 1 BOTTLE CAPSULE, LIQUID FILLED 500 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-862 AMANTADINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [STRIDES PHARMA SCIENCE LIMITED] 7 Current NDC, Legacy NDC, 2 package rows 20230718_20dad861-6ad1-4660-b315-8af57b294175.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 Marketing start Marketing end Sample Exclude flag Status 64380-862-06 64380086206 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (64380-862-06) 2022-12-01 0000-00-00 No No Current 64380-862-07 64380086207 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (64380-862-07) 2022-12-01 0000-00-00 No No Current