Home NDC 68071-4021 Clonazepam
Product NDC 68071-4021
11-digit product format 680714021
Labeler code 68071
Product ID 68071-4021_249d09e4-d2b3-df3d-e063-6394a90a0e31
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
Substance CLONAZEPAM
Active strength .5 mg/1
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2026-12-31
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 · 25 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 2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68071-4021-6 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68071-4021-5 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68071-4021-3 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68071-4021-9 D Discontinued by firm 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 68071-4021-5 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68071-4021-6 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68071-4021-9 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68071-4021-3 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 68071-4021-5 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-4021-6 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-4021-9 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-4021-3 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 68071-4021-5 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-4021-6 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-4021-9 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-4021-3 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 68071-4021-5 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-4021-6 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-4021-9 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-4021-3 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
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 2026-12-31 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 68071-4021-3 2024-07-17 Clonazepam Tablets, USP CIV Rx only 68071-4021-5 2024-07-17 Clonazepam Tablets, USP CIV Rx only 68071-4021-6 2024-07-17 Clonazepam Tablets, USP CIV Rx only 68071-4021-9 2024-07-17 Clonazepam Tablets, USP CIV Rx only 68071-4021-3 2023-01-30 Clonazepam Tablets, USP CIV Rx only 68071-4021-5 2023-01-30 Clonazepam Tablets, USP CIV Rx only 68071-4021-6 2023-01-30 Clonazepam Tablets, USP CIV Rx only 68071-4021-9 2023-01-30 Clonazepam Tablets, USP CIV Rx only 68071-4021-3 2021-02-12 Clonazepam Tablets, USP CIV Rx only 68071-4021-5 2021-02-12 Clonazepam Tablets, USP CIV Rx only 68071-4021-6 2021-02-12 Clonazepam Tablets, USP CIV Rx only 68071-4021-9 2021-02-12 Clonazepam Tablets, USP CIV Rx only 68071-4021-3 2021-01-29 Clonazepam Tablets, USP CIV Rx only 68071-4021-5 2021-01-29 Clonazepam Tablets, USP CIV Rx only 68071-4021-6 2021-01-29 Clonazepam Tablets, USP CIV Rx only 68071-4021-9 2021-01-29 Clonazepam Tablets, USP CIV Rx only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-4021-3 Clonazepam 30 in 1 BOTTLE TABLET 30 6 68071-4021-5 Clonazepam 45 in 1 BOTTLE TABLET 45 6 68071-4021-6 Clonazepam 60 in 1 BOTTLE TABLET 60 6 68071-4021-9 Clonazepam 90 in 1 BOTTLE TABLET 90 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-4021 CLONAZEPAM TABLET [NUCARE PHARMACEUTICALS,INC.] 6 Current NDC, Legacy NDC, 4 package rows 20241018_555061d4-276a-4716-e054-00144ff88e88.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 68071-4021-3 68071402103 30 TABLET in 1 BOTTLE (68071-4021-3) 30 tablet 2017-07-27 0000-00-00 No No Current 68071-4021-5 68071402105 45 TABLET in 1 BOTTLE (68071-4021-5) 45 tablet 2017-07-27 0000-00-00 No No Current 68071-4021-6 68071402106 60 TABLET in 1 BOTTLE (68071-4021-6) 60 tablet 2017-07-27 0000-00-00 No No Current 68071-4021-9 68071402109 90 TABLET in 1 BOTTLE (68071-4021-9) 90 tablet 2017-07-27 0000-00-00 No No Current