Home NDC 0615-0326 Amantadine Hydrochloride
Product NDC 0615-0326
11-digit product format 006150326
Labeler code 0615
Product ID 0615-0326_1e900e41-8b74-41fe-b99e-88dd030c11b7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amantadine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler NCS HealthCare of KY, Inc dba Vangard Labs
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 E
Listing certified through 2017-12-31
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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0615-0326-39 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0615-0326-39 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0615-0326-39 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0615-0326-39 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0615-0326-39 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0615-0326-39 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0615-0326-39 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0615-0326-39 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0615-0326-39 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0615-0326-39 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0615-0326-39 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0615-0326-39 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0615-0326-39 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0615-0326-39 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product I Inactivated by FDA 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0615-0326-39 I Inactivated by FDA 110d247fa046…a55b01930146…
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.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMANTADINE HYDROCHLORIDE ACTIVE INGREDIENT M6Q1EO9TD0 AMANTADINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 AMANTADINE ACTIVE MOIETY BF4C9Z1J53 AMANTADINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMANTADINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 AMANTADINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 ETHYLCELLULOSE (7 MPA.S) INACTIVE INGREDIENT H3UP11403C AMANTADINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD AMANTADINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA AMANTADINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L AMANTADINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMANTADINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T AMANTADINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH AMANTADINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J AMANTADINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AMANTADINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMANTADINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1
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.