Home NDC 45865-575-60 Clonazepam
Product NDC 45865-575
Requested package NDC 45865-575-60
11-digit product format 458650575
Labeler code 45865
Product ID 45865-575_9ab32ff5-aff0-2d1f-e053-2a95a90a592b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clonazepam
Dosage form TABLET
Route ORAL
Labeler Medsource Pharmaceuticals
Application ANDA074869
Marketing category ANDA
Marketing start 2009-02-13
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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A074869-001 CLONAZEPAM CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 A074869-002 CLONAZEPAM CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 A074869-003 CLONAZEPAM CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31
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 · 126 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 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074869-002 CLONAZEPAM 1MG TABLET / ORAL AB 1996-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074869-003 CLONAZEPAM 2MG TABLET / ORAL AB 1996-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074869-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1996-10-31 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 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 45865-575-30 Clonazepam 30 in 1 BOTTLE TABLET 30 2 45865-575-60 Clonazepam 60 in 1 BOTTLE TABLET 60 2
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45865-575 CLONAZEPAM TABLET [MEDSOURCE PHARMACEUTICALS] 2 Legacy NDC, 2 package rows 20191228_1edec3f0-b6c9-1c0f-e054-00144ff8d46c.zip
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 45865-575-60 45865057560 60 TABLET in 1 BOTTLE (45865-575-60) 60 tablet 2015-09-03 0000-00-00 No No Current