Clonazepam

Product NDC
57664-784
11-digit product format
576640784
Labeler code
57664
Product ID
57664-784_ecaa39b8-067f-80d7-e053-2a95a90a7354
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonazepam
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA078654
Marketing category
ANDA
Marketing start
2017-03-29
Marketing end
0000-00-00
Substance
CLONAZEPAM
Active strength
0 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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57664-784DDiscontinued by firm2026-10-05
excluded packagepackage57664-78457664-784-83DDiscontinued by firm2026-10-05
excluded packagepackage57664-78457664-784-86DDiscontinued by firm2026-10-05
excluded packagepackage57664-78457664-784-88DDiscontinued 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 · 32 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 productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-784-86d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-784-88d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-784-83d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-784-86f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-784-88f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-784-83f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-784-862ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-784-882ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-784-832ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-784-86a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-784-88a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-784-83a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-784-86cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-784-88cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-784-83cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-784-86cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-784-88cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-784-83cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-784-86302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-784-88302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-784-83302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-784-86ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-784-88ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-784-83ed331223b511…672a5bd82f5f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078654-001CLONAZEPAMCLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27
A078654-002CLONAZEPAMCLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27
A078654-003CLONAZEPAMCLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27
A078654-004CLONAZEPAMCLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27
A078654-005CLONAZEPAMCLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27

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 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078654-001CLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-2784e616aacf4f…
2026-09-14 22:38:342026-08A078654-002CLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-2784e616aacf4f…
2026-09-14 22:38:342026-08A078654-003CLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-2784e616aacf4f…
2026-09-14 22:38:342026-08A078654-004CLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-2784e616aacf4f…
2026-09-14 22:38:342026-08A078654-005CLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-2784e616aacf4f…
2026-08-18 06:07:402026-07A078654-001CLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078654-002CLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078654-003CLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078654-004CLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078654-005CLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078654-001CLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078654-002CLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078654-003CLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078654-004CLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078654-005CLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078654-001CLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078654-002CLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078654-003CLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078654-004CLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078654-005CLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078654-001CLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078654-002CLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078654-003CLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078654-004CLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078654-005CLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078654-001CLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078654-002CLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078654-003CLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078654-004CLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078654-005CLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078654-001CLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078654-002CLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078654-003CLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078654-004CLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078654-005CLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078654-001CLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORALAB2014-08-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078654-002CLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2014-08-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078654-003CLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2014-08-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078654-004CLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORALAB2014-08-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078654-005CLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2014-08-2703ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 175 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078654-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078654-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078654-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078654-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078654-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078654-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078654-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078654-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078654-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078654-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078654-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078654-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078654-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078654-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078654-005AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078654-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078654-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078654-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078654-004AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078654-005AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078654-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078654-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078654-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078654-004AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078654-005AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078654-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078654-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078654-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078654-004AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078654-005AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078654-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078654-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078654-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078654-004AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078654-005AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078654-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078654-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078654-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078654-004AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078654-005AB11e350fbaab3a…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-784-86EA - Each57664-784ce0121d4-4462-406d-9867-5ea8d7525d6b12017-09-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57664-784-835766407848330 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57664-784-83) 2017-03-290000-00-00NoNoCurrent
57664-784-865766407848660 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57664-784-86) 2017-03-290000-00-00NoNoCurrent
57664-784-8857664078488100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57664-784-88) 2017-03-290000-00-00NoNoCurrent