Home NDC 52959-305 Rimantadine Hydrochloride
Product NDC 52959-305
11-digit product format 529590305
Labeler code 52959
Product ID 52959-305_bf8b4d41-0381-4c4e-9f08-0adf34f0e98c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rimantadine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler H.J. Harkins Company, Inc.
Application ANDA076132
Marketing category ANDA
Marketing start 2005-04-01
Marketing end 0000-00-00
Substance RIMANTADINE 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 2018-12-31
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 · 44 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 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 52959-305-30 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 52959-305-30 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 52959-305-30 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 52959-305-30 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 52959-305-30 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 52959-305-30 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 52959-305-30 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 52959-305-30 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 52959-305-30 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 52959-305-30 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 52959-305-30 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 52959-305-30 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 52959-305-30 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 52959-305-30 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 52959-305-30 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 52959-305-30 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 52959-305-30 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 52959-305-30 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 52959-305-30 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…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 52959-305-30 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 52959-305-30 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 52959-305-30 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A076132-001 RIMANTADINE HYDROCHLORIDE RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL RS 2002-08-30
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 · 43 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 2026-09-14 22:38:34 2026-08 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL RS 2002-08-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL RS 2002-08-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL RS 2002-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL RS 2002-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL RS 2002-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL RS 2002-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL RS 2002-08-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL RS 2002-08-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL RS 2002-08-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL RS 2002-08-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL RS 2002-08-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL RS 2002-08-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL RS 2002-08-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL RS 2002-08-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL RS 2002-08-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL RS 2002-08-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-08-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-08-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-08-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-08-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-08-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-08-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-08-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-08-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-08-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-08-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-08-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-08-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-08-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL RS 2002-08-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL RS 2002-08-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL RS 2002-08-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-08-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-08-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-08-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-08-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-08-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-08-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-08-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076132-001 RIMANTADINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2002-08-30 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 52959-305-30 Rimantalist 30 in 1 BOTTLE TABLET 30 100 mg 8 52959-305-30 Rimantadine Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ARGININE ACTIVE INGREDIENT 94ZLA3W45F RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC] 8 RIMANTADINE HYDROCHLORIDE ACTIVE INGREDIENT JEI07OOS8Y RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC] 8 ARGININE ACTIVE MOIETY 94ZLA3W45F RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC] 8 RIMANTADINE ACTIVE MOIETY 0T2EF4JQTU RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC] 8 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC] 8 GELATIN INACTIVE INGREDIENT 2G86QN327L RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC] 8 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC] 8 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC] 8 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC] 8 WATER INACTIVE INGREDIENT 059QF0KO0R RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC] 8 Rimantadine Hydrochloride ACTIVE INGREDIENT JEI07OOS8Y RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 Rimantadine ACTIVE MOIETY 0T2EF4JQTU RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52959-305 RIMANTALIST (RIMANTADINE HYDROCHLORIDE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC] 8 Legacy NDC 20110815_870089d6-87e4-46b9-bcfb-c5b82cf06c3f.zip 52959-305 RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 Legacy NDC, 1 package rows 20111229_48842cd7-2d78-455a-a688-b148347b6dd5.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 52959-305-30 52959030530 30 in 1 BOTTLE Historical