Home NDC 43353-947 Amantadine Hydrochloride
Product NDC 43353-947
11-digit product format 433530947
Labeler code 43353
Product ID 43353-947_de10cd2f-4523-4c70-96f3-9d238c6d74c7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amantadine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA071293
Marketing category ANDA
Marketing start 1987-02-18
Marketing end 0000-00-00
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 2019-12-31
Current FDA listing Historical FDA.report record 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 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43353-947-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43353-947-05 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 43353-947-05 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 43353-947-05 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 43353-947-05 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 43353-947-05 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 43353-947-05 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 43353-947-05 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 43353-947-05 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 43353-947-05 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 43353-947-05 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 43353-947-05 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 43353-947-05 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 43353-947-05 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 43353-947-05 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 43353-947-05 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 43353-947-05 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 43353-947-05 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 43353-947-05 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 43353-947-05 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 43353-947-05 9bebd1f3094a…5416666fcb17…
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.
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 43353-947-05 Amantadine Hydrochloride 4200 in 1 BOTTLE, PLASTIC CAPSULE 4200 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMANTADINE HYDROCHLORIDE ACTIVE INGREDIENT M6Q1EO9TD0 AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 AMANTADINE ACTIVE MOIETY BF4C9Z1J53 AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 ETHYLCELLULOSE (7 MPA.S) INACTIVE INGREDIENT H3UP11403C AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-947 AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC, 1 package rows 20140611_99351f6a-82d7-4d3b-a214-e48260a63d05.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 Status 43353-947-05 43353094705 4200 in 1 BOTTLE, PLASTIC Historical