Home NDC 71765-009 AMANTADINE HYDROCHLORIDE
Product NDC 71765-009
11-digit product format 717650009
Labeler code 71765
Product ID 71765-009_4df85675-4d84-2a33-e063-6394a90a9ddc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amantadine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Zhejiang Jutai Pharmaceutical Co., Ltd.
Application ANDA218598
Marketing category ANDA
Marketing start 2024-09-26
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 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 A218598-001 AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-09-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218598-001 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 A218598-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-09-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218598-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218598-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218598-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218598-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218598-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218598-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218598-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-09-26 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218598-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-09-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218598-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-09-26 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218598-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2024-09-26 a50c72e98297…
Observed Orange Book normalized TE history# 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 849395 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 71765-009-01 AMANTADINE HYDROCHLORIDE 2 in 1 BOX TABLET 2 4 71765-009-01 AMANTADINE HYDROCHLORIDE 12 in 1 BLISTER PACK TABLET 12 4
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 71765-009-01 71765000901 2 BLISTER PACK in 1 BOX (71765-009-01) / 12 TABLET in 1 BLISTER PACK 2 blister pack 2024-09-26 No No Current