Home NDC 70518-1801 Clonazepam
Product NDC 70518-1801
11-digit product format 705181801
Labeler code 70518
Product ID 70518-1801_4d2345d3-593a-fb2f-e063-6394a90a713f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clonazepam
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA077147
Marketing category ANDA
Marketing start 2019-01-16
Substance CLONAZEPAM
Active strength .5 mg/1
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 70518-1801-0 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 70518-1801-0 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 70518-1801-0 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 70518-1801-0 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 70518-1801-0 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 70518-1801-0 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 70518-1801-0 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 70518-1801-0 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 70518-1801-0 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 70518-1801-0 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 70518-1801-0 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 70518-1801-0 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A077147-001 CLONAZEPAM CLONAZEPAM 0.5MG TABLET / ORAL AB 2005-05-02 A077147-002 CLONAZEPAM CLONAZEPAM 1MG TABLET / ORAL AB 2005-05-02 A077147-003 CLONAZEPAM CLONAZEPAM 2MG TABLET / ORAL AB 2005-05-02
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 1 of 4 · 129 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 A077147-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 2005-05-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077147-002 CLONAZEPAM 1MG TABLET / ORAL AB 2005-05-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077147-003 CLONAZEPAM 2MG TABLET / ORAL AB 2005-05-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077147-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 2005-05-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077147-002 CLONAZEPAM 1MG TABLET / ORAL AB 2005-05-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077147-003 CLONAZEPAM 2MG TABLET / ORAL AB 2005-05-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077147-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 2005-05-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077147-002 CLONAZEPAM 1MG TABLET / ORAL AB 2005-05-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077147-003 CLONAZEPAM 2MG TABLET / ORAL AB 2005-05-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077147-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 2005-05-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077147-002 CLONAZEPAM 1MG TABLET / ORAL AB 2005-05-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077147-003 CLONAZEPAM 2MG TABLET / ORAL AB 2005-05-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077147-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 2005-05-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077147-002 CLONAZEPAM 1MG TABLET / ORAL AB 2005-05-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077147-003 CLONAZEPAM 2MG TABLET / ORAL AB 2005-05-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077147-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 2005-05-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077147-002 CLONAZEPAM 1MG TABLET / ORAL AB 2005-05-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077147-003 CLONAZEPAM 2MG TABLET / ORAL AB 2005-05-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077147-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 2005-05-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077147-002 CLONAZEPAM 1MG TABLET / ORAL AB 2005-05-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077147-003 CLONAZEPAM 2MG TABLET / ORAL AB 2005-05-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077147-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 2005-05-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077147-002 CLONAZEPAM 1MG TABLET / ORAL AB 2005-05-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077147-003 CLONAZEPAM 2MG TABLET / ORAL AB 2005-05-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077147-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 2005-05-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077147-002 CLONAZEPAM 1MG TABLET / ORAL AB 2005-05-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077147-003 CLONAZEPAM 2MG TABLET / ORAL AB 2005-05-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077147-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 2005-05-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077147-002 CLONAZEPAM 1MG TABLET / ORAL AB 2005-05-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077147-003 CLONAZEPAM 2MG TABLET / ORAL AB 2005-05-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077147-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 2005-05-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077147-002 CLONAZEPAM 1MG TABLET / ORAL AB 2005-05-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077147-003 CLONAZEPAM 2MG TABLET / ORAL AB 2005-05-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077147-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 2005-05-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077147-002 CLONAZEPAM 1MG TABLET / ORAL AB 2005-05-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077147-003 CLONAZEPAM 2MG TABLET / ORAL AB 2005-05-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077147-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 2005-05-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077147-002 CLONAZEPAM 1MG TABLET / ORAL AB 2005-05-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077147-003 CLONAZEPAM 2MG TABLET / ORAL AB 2005-05-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077147-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 2005-05-02 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Clonazepam
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLONAZEPAM .5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5PE9FDE8GB Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197527 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 70518-1801-0 Clonazepam 100 in 1 BOX TABLET 100 8 70518-1801-1 Clonazepam 1 in 1 POUCH TABLET 1 8
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 2 of 2 · 23 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 70518-1801-0 70518180100 100 POUCH in 1 BOX (70518-1801-0) / 1 TABLET in 1 POUCH (70518-1801-1) 100 pouch 2019-01-16 0000-00-00 No No Current 70518-1801-1 70518180101 1 in 1 POUCH Historical