Clonazepam

Product NDC
70518-2467
11-digit product format
705182467
Labeler code
70518
Product ID
70518-2467_ec92e6e9-ae22-7f8a-e053-2995a90aee75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077856
Marketing category
ANDA
Marketing start
2019-12-05
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-2467DDiscontinued by firm2026-10-05
excluded packagepackage70518-246770518-2467-0DDiscontinued by firm2026-10-05
excluded packagepackage70518-246770518-2467-1DDiscontinued by firm2026-10-05
excluded packagepackage70518-246770518-2467-3DDiscontinued by firm2026-10-05
excluded packagepackage70518-246770518-2467-4DDiscontinued by firm2026-10-05

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 · 35 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-2467-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-2467-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-2467-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-2467-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-2467-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-2467-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-2467-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-2467-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-2467-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-2467-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-2467-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-2467-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-2467-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-2467-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-2467-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-2467-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-2467-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-2467-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-2467-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-2467-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-2467-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-2467-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-2467-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-2467-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-2467-00efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-2467-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-2467-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-2467-0ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-2467-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-2467-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-2467-0367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-2467-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-2467-1367a005e9d99…383a685ebd0f…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077856-001CLONAZEPAMCLONAZEPAM0.5MGTABLET / ORALAB2006-06-28
A077856-002CLONAZEPAMCLONAZEPAM1MGTABLET / ORALAB2006-06-28
A077856-003CLONAZEPAMCLONAZEPAM2MGTABLET / ORALAB2006-06-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077856-001AB
A077856-002AB
A077856-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-2884e616aacf4f…
2026-09-14 22:38:342026-08A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-2884e616aacf4f…
2026-09-14 22:38:342026-08A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-2884e616aacf4f…
2026-08-18 06:07:402026-07A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-28301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077856-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077856-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077856-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A077856-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077856-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077856-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077856-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077856-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077856-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077856-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077856-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077856-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077856-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077856-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077856-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077856-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077856-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077856-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077856-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077856-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077856-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077856-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077856-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077856-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077856-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077856-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077856-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077856-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077856-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077856-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077856-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077856-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077856-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077856-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077856-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077856-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077856-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077856-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077856-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077856-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f8e2a02d-e7b1-29aa-eb39-98a679441d91Product name320190927
dc4336d1-53d4-d410-38d3-71aa2ce4749bProduct name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2467CLONAZEPAM TABLET [REMEDYREPACK INC.]11Legacy NDC20250316_3c926082-d2fe-4dc0-bca4-4dd8f82f09ee.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 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClonazepamCLONAZEPAMBryant Ranch Prepackf06dc5fc-94e0-496e-bdf0-11f2b6ffc7862024-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepack254a03c9-070c-40e6-83ac-524c1aec3b6b2024-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMNuCare Pharmaceuticals,Inc.19b1fe7b-8f7b-03b7-e063-6394a90a9ba52024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC154806ed-91af-fc7f-e063-6294a90ae0f42024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepack5ec3df57-1137-4402-84e6-28dd762864272024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC2cb46dc0-a03e-42d7-ba67-22319598389f2024-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepackbaa86bf1-75f3-44da-b67f-b6e4b5303f1e2024-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepackcd364371-d2af-4cb4-a5df-3d3149580e162024-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepackd732be07-6eb7-48f2-b6cd-28baad46aca52024-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepack5f3a2f64-57ed-475c-9d8c-b2094bf1d79e2023-10-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepack5ae98718-9da5-4edc-8efb-67b2125775482023-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepackcc14bb7b-d0c8-4f41-bcd9-a0c860b45a432023-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMProficient Rx LP645fb912-479c-46de-b99c-4ea341bfd9ba2023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepack6960e994-e9ea-4a4a-b674-7e6124d8b3812023-05-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMProficient Rx LP63286201-4b79-45b8-8f48-7e21dadc14082021-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2467-07051824670030 TABLET in 1 BLISTER PACK (70518-2467-0) 30 tablet2019-12-050000-00-00NoNoCurrent
70518-2467-170518246701100 POUCH in 1 BOX (70518-2467-1) > 1 TABLET in 1 POUCH (70518-2467-2) 100 pouch2020-01-090000-00-00NoNoCurrent