Home NDC 68071-2310 Clonazepam
Product NDC 68071-2310
11-digit product format 680712310
Labeler code 68071
Product ID 68071-2310_d59062ee-e442-022f-e053-2a95a90a7d20
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clonazepam
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA077147
Marketing category ANDA
Marketing start 2011-06-03
Marketing end 0000-00-00
Substance CLONAZEPAM
Active strength 2 mg/1
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2023-12-31
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 · 18 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 68071-2310-6 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 68071-2310-6 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 68071-2310-6 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 68071-2310-6 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 68071-2310-6 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 68071-2310-6 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68071-2310-6 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68071-2310-6 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68071-2310-6 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 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 · 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 2026-10-15 13:18:30 2026-09 A077147-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 2005-05-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077147-002 CLONAZEPAM 1MG TABLET / ORAL AB 2005-05-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077147-003 CLONAZEPAM 2MG TABLET / ORAL AB 2005-05-02 c2088c7a36db…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…
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.
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 68071-2310-6 Clonazepam 60 in 1 BOTTLE, PLASTIC TABLET 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-2310 CLONAZEPAM TABLET [NUCARE PHARMACEUTICALS,INC.] 2 Legacy NDC, 1 package rows 20220115_b5f7cfb2-2988-5f00-e053-2a95a90aae6d.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 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 68071-2310-6 68071231006 60 TABLET in 1 BOTTLE, PLASTIC (68071-2310-6) 60 tablet 2020-12-08 0000-00-00 No No Current