Home NDC 0832-1015-00 Amantadine Hydrochloride
Product NDC 0832-1015
Requested package NDC 0832-1015-00
11-digit product format 008321015
Labeler code 0832
Product ID 0832-1015_398493aa-8a67-10e2-e063-6394a90aef8d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amantadine hydrochloride
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Application ANDA070589
Marketing category ANDA
Marketing start 2011-09-15
Marketing end 2026-12-31
Substance AMANTADINE HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]
NDC exclude flag No
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A070589-001 AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070589-001 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 · 41 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 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A070589-001 AMANTADINE HYDROCHLORIDE 100MG CAPSULE / ORAL AB 1986-08-05 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Amantadine Hydrochloride 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 0832-1015-00 Amantadine Hydrochloride 100 in 1 BOTTLE CAPSULE, GELATIN COATED 100 19 0832-1015-50 Amantadine Hydrochloride 500 in 1 BOTTLE CAPSULE, GELATIN COATED 500 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded amantadine hydrochloride ACTIVE INGREDIENT M6Q1EO9TD0 AMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, INC] 12 amantadine ACTIVE MOIETY BF4C9Z1J53 AMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, INC] 12 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G AMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, INC] 12 GELATIN INACTIVE INGREDIENT 2G86QN327L AMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, INC] 12 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX AMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, INC] 12 HYDROGENATED COTTONSEED OIL INACTIVE INGREDIENT Z82Y2C65EA AMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, INC] 12 HYDROGENATED SOYBEAN OIL INACTIVE INGREDIENT A2M91M918C AMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, INC] 12 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 AMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, INC] 12 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, INC] 12 SOYBEAN OIL INACTIVE INGREDIENT 241ATL177A AMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, INC] 12 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, INC] 12 WHITE WAX INACTIVE INGREDIENT 7G1J5DA97F AMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, INC] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0832-1015 AMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [UPSHER-SMITH LABORATORIES, LLC] 18 Current NDC, Legacy NDC, 2 package rows 20230524_5232b933-1df9-43b4-8ac2-61bfa4855e68.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 0832-1015-00 00832101500 100 CAPSULE, GELATIN COATED in 1 BOTTLE (0832-1015-00) 2011-09-15 2026-12-31 No No Current