Home NDC 70518-1069 Clonazepam
Product NDC 70518-1069
11-digit product format 705181069
Labeler code 70518
Product ID 70518-1069_901094da-8d7c-6b25-e053-2a95a90a1f0f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clonazepam
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA074979
Marketing category ANDA
Marketing start 2018-03-15
Marketing end 0000-00-00
Substance CLONAZEPAM
Active strength 1 mg/1
Pharmacologic classes Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2020-12-31
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 · 24 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 70518-1069-0 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 70518-1069-0 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 70518-1069-0 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 70518-1069-0 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 70518-1069-0 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 70518-1069-0 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 70518-1069-0 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 70518-1069-0 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 70518-1069-0 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 70518-1069-0 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 70518-1069-0 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 70518-1069-0 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074979-001 CLONAZEPAM CLONAZEPAM 0.5MG TABLET / ORAL AB 1997-08-29 A074979-002 CLONAZEPAM CLONAZEPAM 1MG TABLET / ORAL AB 1997-08-29 A074979-003 CLONAZEPAM CLONAZEPAM 2MG TABLET / ORAL AB 1997-08-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 3 of 4 · 132 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 2020-11-12 02:37 UTC 2020-11 A074979-003 CLONAZEPAM 2MG TABLET / ORAL AB 1997-08-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074979-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1997-08-29 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A074979-002 CLONAZEPAM 1MG TABLET / ORAL AB 1997-08-29 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A074979-003 CLONAZEPAM 2MG TABLET / ORAL AB 1997-08-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074979-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1997-08-29 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A074979-002 CLONAZEPAM 1MG TABLET / ORAL AB 1997-08-29 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A074979-003 CLONAZEPAM 2MG TABLET / ORAL AB 1997-08-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074979-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1997-08-29 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A074979-002 CLONAZEPAM 1MG TABLET / ORAL AB 1997-08-29 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A074979-003 CLONAZEPAM 2MG TABLET / ORAL AB 1997-08-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074979-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1997-08-29 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074979-002 CLONAZEPAM 1MG TABLET / ORAL AB 1997-08-29 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074979-003 CLONAZEPAM 2MG TABLET / ORAL AB 1997-08-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074979-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1997-08-29 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A074979-002 CLONAZEPAM 1MG TABLET / ORAL AB 1997-08-29 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A074979-003 CLONAZEPAM 2MG TABLET / ORAL AB 1997-08-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074979-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1997-08-29 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A074979-002 CLONAZEPAM 1MG TABLET / ORAL AB 1997-08-29 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A074979-003 CLONAZEPAM 2MG TABLET / ORAL AB 1997-08-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074979-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1997-08-29 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074979-002 CLONAZEPAM 1MG TABLET / ORAL AB 1997-08-29 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074979-003 CLONAZEPAM 2MG TABLET / ORAL AB 1997-08-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074979-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1997-08-29 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074979-002 CLONAZEPAM 1MG TABLET / ORAL AB 1997-08-29 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074979-003 CLONAZEPAM 2MG TABLET / ORAL AB 1997-08-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074979-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1997-08-29 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074979-002 CLONAZEPAM 1MG TABLET / ORAL AB 1997-08-29 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074979-003 CLONAZEPAM 2MG TABLET / ORAL AB 1997-08-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074979-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1997-08-29 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074979-002 CLONAZEPAM 1MG TABLET / ORAL AB 1997-08-29 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074979-003 CLONAZEPAM 2MG TABLET / ORAL AB 1997-08-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074979-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1997-08-29 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A074979-002 CLONAZEPAM 1MG TABLET / ORAL AB 1997-08-29 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A074979-003 CLONAZEPAM 2MG TABLET / ORAL AB 1997-08-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074979-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1997-08-29 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A074979-002 CLONAZEPAM 1MG TABLET / ORAL AB 1997-08-29 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A074979-003 CLONAZEPAM 2MG TABLET / ORAL AB 1997-08-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074979-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1997-08-29 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074979-002 CLONAZEPAM 1MG TABLET / ORAL AB 1997-08-29 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074979-003 CLONAZEPAM 2MG TABLET / ORAL AB 1997-08-29 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.