Clonazepam

Product NDC
50090-4842
11-digit product format
500904842
Labeler code
50090
Product ID
50090-4842_fe2dfee0-0c61-45d2-b5df-c611d7e644f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA074569
Marketing category
ANDA
Marketing start
1996-09-18
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
2022-12-31
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 productproduct50090-4842IInactivated by FDA2026-08-17
excluded packagepackage50090-484250090-4842-0IInactivated by FDA2026-08-17

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 · 30 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 packagepackage50090-4842-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-4842-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-4842-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-4842-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-4842-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-4842-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-4842-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-4842-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-4842-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-4842-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-4842-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-4842-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-4842-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-4842-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-4842-01332a3947898…d4bfe170f9cd…

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
A074569-001CLONAZEPAMCLONAZEPAM0.5MGTABLET / ORALAB1996-09-10
A074569-002CLONAZEPAMCLONAZEPAM1MGTABLET / ORALAB1996-09-10
A074569-003CLONAZEPAMCLONAZEPAM2MGTABLET / ORALAB1996-09-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074569-001AB
A074569-002AB
A074569-003AB

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 06:07:402026-07A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-101e350fbaab3a…

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 06:07:402026-07A074569-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074569-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074569-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074569-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074569-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074569-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074569-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074569-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074569-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074569-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074569-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074569-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074569-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074569-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074569-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074569-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074569-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074569-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074569-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074569-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074569-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074569-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074569-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074569-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074569-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074569-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074569-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074569-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074569-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074569-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074569-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074569-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074569-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074569-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074569-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074569-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074569-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074569-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074569-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074569-001AB11e350fbaab3a…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4842-02023-01-30C16284748780-1f386c649-d61a-0266-e053-dadaa90a7c1aCLONAZEPAM TABLETS USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4842-0Clonazepam1 in 1 BLISTER PACKTABLET13
50090-4842-0Clonazepam33 in 1 BOX, UNIT-DOSETABLET333

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4842CLONAZEPAM TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20210417_f92220d7-fdfe-4ddc-acde-3e7708578513.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 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClonazepamCLONAZEPAMREMEDYREPACK INC.64bb2cdf-f57d-4a41-a5bf-ee77b6e64d062026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ClonazepamCLONAZEPAMCoupler LLC54d6e348-4c51-221e-e063-6294a90a9b7d2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ClonazepamCLONAZEPAMREMEDYREPACK INC.b1c53213-9f84-4389-b6dc-3dc26d9a63642026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ClonazepamCLONAZEPAMA-S Medication Solutionsb3c9d04a-431f-4cec-a809-847dfb8de7362024-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ClonazepamCLONAZEPAMClinical Solutions Wholesale, LLC429a15d1-1675-42cc-97f1-c49b037474162024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC73125f86-ce24-44c0-a2b1-a5d12a607a942023-11-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC6be64dc3-3748-477c-8800-2c2175309c732023-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ClonazepamCLONAZEPAMTeva Pharmaceuticals USA, Inc.8069b1a0-7c06-4252-b44e-e2eef065d9b82023-04-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ClonazepamCLONAZEPAMProficient Rx LP56175c25-3fde-43ea-89bf-22dcf3278b6b2022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSNf92220d7-fdfe-4ddc-acde-3e77085785133
197527clonazepam 0.5 MG Oral TabletSCDf92220d7-fdfe-4ddc-acde-3e77085785133

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4842-0500904842001 BOX, UNIT-DOSE in 1 BLISTER PACK (50090-4842-0) > 33 TABLET in 1 BOX, UNIT-DOSE2020-01-200000-00-00NoNoCurrent