Home NDC 0832-0111 Amantadine Hydrochloride
Product NDC 0832-0111
11-digit product format 008320111
Labeler code 0832
Product ID 0832-0111_45af44df-1a9b-32b6-e063-6394a90acdaf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amantadine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Application ANDA076186
Marketing category ANDA
Marketing start 2011-12-15
Marketing end 2028-02-29
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 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 A076186-001 AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076186-001 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 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076186-001 AMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2002-12-16 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 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 0832-0111-00 Amantadine Hydrochloride 100 in 1 BOTTLE TABLET 100 11 0832-0111-03 Amantadine Hydrochloride 100 in 1 CARTON TABLET 100 11 0832-0111-50 Amantadine Hydrochloride 500 in 1 BOTTLE TABLET 500 11 0832-0111-89 Amantadine Hydrochloride 1 in 1 BLISTER PACK TABLET 1 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded amantadine hydrochloride ACTIVE INGREDIENT M6Q1EO9TD0 AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC] 3 amantadine ACTIVE MOIETY BF4C9Z1J53 AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC] 3 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC] 3 STARCH, POTATO INACTIVE INGREDIENT 8I089SAH3T AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0832-0111 AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, LLC] 8 Current NDC, Legacy NDC, 4 package rows 20230519_63d9d4aa-5f92-45b0-98d0-d6ec38b727cb.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 Marketing end Sample Exclude flag Status 0832-0111-00 00832011100 100 TABLET in 1 BOTTLE (0832-0111-00) 100 tablet 2011-12-15 2028-02-29 No No Current 0832-0111-03 00832011103 100 BLISTER PACK in 1 CARTON (0832-0111-03) / 1 TABLET in 1 BLISTER PACK (0832-0111-89) 100 blister pack 2017-07-07 2026-08-31 No No Current 0832-0111-50 00832011150 500 TABLET in 1 BOTTLE (0832-0111-50) 500 tablet 2011-12-15 2028-02-29 No No Current 0832-0111-89 00832011189 1 in 1 BLISTER PACK Historical