Clonazepam

Product NDC
0904-7728
11-digit product format
009047728
Labeler code
0904
Product ID
0904-7728_8a2394b5-5506-4279-a197-8955379df72d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA077856
Marketing category
ANDA
Marketing start
2022-08-23
Substance
CLONAZEPAM
Active strength
1 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

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
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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077856-001CLONAZEPAM0.5MGTABLET / 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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-281e350fbaab3a…

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 06:07:402026-07A077856-001AB1caaa826d4ba7…
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077856-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077856-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077856-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Clonazepam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONAZEPAM1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5PE9FDE8GBInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197527Internal RxNorm lookup
197528Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
34366dd2-432c-4fa9-8fab-832cca781b84Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7728-61Clonazepam100 in 1 CARTONTABLET1006
0904-7728-61Clonazepam1 in 1 BLISTER PACKTABLET16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7728-61EA - Each0904-7728998512f7-e26c-4bbf-bd0a-91a938d48c5012023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7728CLONAZEPAM TABLET [MAJOR PHARMACEUTICALS]4Current NDC, Legacy NDC, 2 package rows20250212_34366dd2-432c-4fa9-8fab-832cca781b84.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 1 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClonazepamCLONAZEPAMREMEDYREPACK INC.533a12a8-64fb-494f-a2a4-da1515ef19082026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMMajor Pharmaceuticals34366dd2-432c-4fa9-8fab-832cca781b842026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ndc (product): 0904-7728
ClonazepamCLONAZEPAMCoupler LLC511216c7-6878-f90a-e063-6394a90aaac82026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMCardinal Health 107, LLC5ad315f2-fa09-4956-b931-f9966fb73e4e2026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMPreferred Pharmaceuticals Inc.2fe0d214-9c4d-4a0c-9024-c2076c092c1a2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMPreferred Pharmaceuticals Inc.87f362a7-cf66-4166-af51-ac2da473cf6b2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMPreferred Pharmaceuticals Inc.939dee35-3987-4ce2-9985-3751ceffa20e2026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMAvPAKf2662808-01c4-330c-e053-2a95a90aa3352026-02-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMPD-Rx Pharmaceuticals, Inc.08d0a109-3307-47b5-8ff2-c0ad83e66f082025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMPD-Rx Pharmaceuticals, Inc.9a74ea97-1c00-4d96-a06f-81c183943dc62025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMPD-Rx Pharmaceuticals, Inc.ca79f244-7e6e-4612-af26-e6e5cefbd3a22025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMSolco Healthcare LLC4acbb7a9-4db5-4497-b8db-9f358b3f6fb42025-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMAmerican Health Packagingc13297e2-ae3e-4198-b7c8-55fd672436aa2025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMDirect_Rxfc75869c-cd6b-44a3-e053-6294a90a699e2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
CLONAZEPAMCLONAZEPAMDIRECT RXa821f647-be5f-274c-e053-2a95a90a23ce2025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC263f99eb-9744-5601-e063-6394a90a47b12024-11-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC66bf60fa-61ac-47a7-a081-36077af9007e2024-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepackb12661a6-2141-42a9-bcb0-c0aef81395ce2024-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepackb83009c2-26ed-45fa-819e-164cdac264e62024-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepack96518266-8f75-4301-b8fd-d2995a7f486d2024-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSN34366dd2-432c-4fa9-8fab-832cca781b846
197528clonazePAM 1 MG Oral TabletPSN34366dd2-432c-4fa9-8fab-832cca781b846
197527clonazepam 0.5 MG Oral TabletSCD34366dd2-432c-4fa9-8fab-832cca781b846
197528clonazepam 1 MG Oral TabletSCD34366dd2-432c-4fa9-8fab-832cca781b846
197527clonazePAM 0.5 MG Oral TabletPSN5ad315f2-fa09-4956-b931-f9966fb73e4e4
197528clonazePAM 1 MG Oral TabletPSN5ad315f2-fa09-4956-b931-f9966fb73e4e4
197527clonazepam 0.5 MG Oral TabletSCD5ad315f2-fa09-4956-b931-f9966fb73e4e4
197528clonazepam 1 MG Oral TabletSCD5ad315f2-fa09-4956-b931-f9966fb73e4e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7728-6100904772861100 BLISTER PACK in 1 CARTON (0904-7728-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2022-08-230000-00-00NoNoCurrent