Clonazepam

Product NDC
63739-264
11-digit product format
637390264
Labeler code
63739
Product ID
63739-264_15dc492e-7b3a-4c94-904a-2fe6eea42cab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA074869
Marketing category
ANDA
Marketing start
2007-08-02
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63739-264DDiscontinued by firm2026-08-17
excluded packagepackage63739-26463739-264-10DDiscontinued by firm2026-08-17

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 · 24 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 packagepackage63739-264-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63739-264-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63739-264-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63739-264-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63739-264-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63739-264-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63739-264-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63739-264-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63739-264-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63739-264-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63739-264-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63739-264-10557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074869-001CLONAZEPAMCLONAZEPAM0.5MGTABLET / ORALAB1996-10-31
A074869-002CLONAZEPAMCLONAZEPAM1MGTABLET / ORALAB1996-10-31
A074869-003CLONAZEPAMCLONAZEPAM2MGTABLET / ORALAB1996-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074869-001AB
A074869-002AB
A074869-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074869-001CLONAZEPAM0.5MGTABLET / ORALAB1996-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A074869-002CLONAZEPAM1MGTABLET / ORALAB1996-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A074869-003CLONAZEPAM2MGTABLET / ORALAB1996-10-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074869-001CLONAZEPAM0.5MGTABLET / ORALAB1996-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074869-002CLONAZEPAM1MGTABLET / ORALAB1996-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074869-003CLONAZEPAM2MGTABLET / ORALAB1996-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074869-001CLONAZEPAM0.5MGTABLET / ORALAB1996-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074869-002CLONAZEPAM1MGTABLET / ORALAB1996-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074869-003CLONAZEPAM2MGTABLET / ORALAB1996-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074869-001CLONAZEPAM0.5MGTABLET / ORALAB1996-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074869-002CLONAZEPAM1MGTABLET / ORALAB1996-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074869-003CLONAZEPAM2MGTABLET / ORALAB1996-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074869-001CLONAZEPAM0.5MGTABLET / ORALAB1996-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074869-002CLONAZEPAM1MGTABLET / ORALAB1996-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074869-003CLONAZEPAM2MGTABLET / ORALAB1996-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074869-001CLONAZEPAM0.5MGTABLET / ORALAB1996-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074869-002CLONAZEPAM1MGTABLET / ORALAB1996-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074869-003CLONAZEPAM2MGTABLET / ORALAB1996-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074869-001CLONAZEPAM0.5MGTABLET / ORALAB1996-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074869-002CLONAZEPAM1MGTABLET / ORALAB1996-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074869-003CLONAZEPAM2MGTABLET / ORALAB1996-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074869-001CLONAZEPAM0.5MGTABLET / ORALAB1996-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074869-002CLONAZEPAM1MGTABLET / ORALAB1996-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074869-003CLONAZEPAM2MGTABLET / ORALAB1996-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074869-001CLONAZEPAM0.5MGTABLET / ORALAB1996-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074869-002CLONAZEPAM1MGTABLET / ORALAB1996-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074869-003CLONAZEPAM2MGTABLET / ORALAB1996-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074869-001CLONAZEPAM0.5MGTABLET / ORALAB1996-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074869-002CLONAZEPAM1MGTABLET / ORALAB1996-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074869-003CLONAZEPAM2MGTABLET / ORALAB1996-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074869-001CLONAZEPAM0.5MGTABLET / ORALAB1996-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A074869-002CLONAZEPAM1MGTABLET / ORALAB1996-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A074869-003CLONAZEPAM2MGTABLET / ORALAB1996-10-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074869-001CLONAZEPAM0.5MGTABLET / ORALAB1996-10-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074869-002CLONAZEPAM1MGTABLET / ORALAB1996-10-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074869-003CLONAZEPAM2MGTABLET / ORALAB1996-10-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074869-001CLONAZEPAM0.5MGTABLET / ORALAB1996-10-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074869-002CLONAZEPAM1MGTABLET / ORALAB1996-10-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074869-003CLONAZEPAM2MGTABLET / ORALAB1996-10-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074869-001CLONAZEPAM0.5MGTABLET / ORALAB1996-10-311e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A074869-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074869-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074869-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074869-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074869-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074869-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074869-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074869-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074869-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074869-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074869-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074869-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074869-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074869-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074869-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074869-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074869-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074869-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074869-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074869-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074869-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074869-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074869-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074869-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074869-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074869-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074869-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074869-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074869-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074869-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074869-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074869-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074869-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074869-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074869-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074869-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074869-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074869-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074869-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074869-001AB11e350fbaab3a…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63739-264-102020-07-22C16284748780-1ab0e2407-315a-f274-e053-dbdaa90a6471CLONAZEPAM TABLETS, USP CIV

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-264-10EA - Each63739-264b79aa86c-6304-4752-96dd-1c09b374cb3f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONAZEPAMACTIVE INGREDIENT5PE9FDE8GBCLONAZEPAM TABLET [CARDINAL HEALTH]1
CLONAZEPAMACTIVE INGREDIENT5PE9FDE8GBCLONAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
CLONAZEPAMACTIVE MOIETY5PE9FDE8GBCLONAZEPAM TABLET [CARDINAL HEALTH]1
CLONAZEPAMACTIVE MOIETY5PE9FDE8GBCLONAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLONAZEPAM TABLET [CARDINAL HEALTH]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLONAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BCLONAZEPAM TABLET [CARDINAL HEALTH]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BCLONAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLONAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONAZEPAM TABLET [CARDINAL HEALTH]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONAZEPAM TABLET [CARDINAL HEALTH]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONAZEPAM TABLET [CARDINAL HEALTH]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1