Clonazepam

Product NDC
71610-367
Requested package NDC
71610-367-45
11-digit product format
716100367
Labeler code
71610
Product ID
71610-367_8f4b7c9b-ba53-480e-afd5-4529b1a00219
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA074569
Marketing category
ANDA
Marketing start
1996-09-18
Marketing end
0000-00-00
Substance
CLONAZEPAM
Active strength
2 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 packagepackage71610-36771610-367-45IInactivated by FDA2026-10-05
excluded packagepackage71610-36771610-367-45UExcluded because listing certification expired2026-10-05

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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29EExcluded after deficient or non-compliant submission was not correctedfb8cb913e6d1…eb8c232b6be0…

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
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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-1084e616aacf4f…
2026-09-14 22:38:342026-08A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-1084e616aacf4f…
2026-09-14 22:38:342026-08A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-1084e616aacf4f…
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…

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 22:38:342026-08A074569-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A074569-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A074569-003AB184e616aacf4f…
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…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-367-15Clonazepam15 in 1 BOTTLETABLET157
71610-367-30Clonazepam30 in 1 BOTTLETABLET307
71610-367-45Clonazepam45 in 1 BOTTLETABLET457
71610-367-53Clonazepam60 in 1 BOTTLETABLET607
71610-367-60Clonazepam90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-367-15EA - Each71610-367d9f75114-9573-48a0-904b-326d34c5b26512020-01-03
71610-367-30EA - Each71610-367097d8051-aa22-4de3-82a3-06f6a282bc4312020-01-03
71610-367-45EA - Each71610-3671fc6be13-f057-490b-99d0-cda2f8fdfff512020-01-03
71610-367-53EA - Each71610-36704f186f5-b84e-4e10-bab8-0e138a169eb212020-01-03
71610-367-60EA - Each71610-367a08750bf-f8a2-44fa-a2c3-dc368760ba5512020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-367CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]7Legacy NDC, 5 package rows20240228_4ad20ef6-7bc6-4bdc-9fd9-cd5feb1e150f.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
197528clonazePAM 1 MG Oral TabletPSN4ad20ef6-7bc6-4bdc-9fd9-cd5feb1e150f7
197529clonazePAM 2 MG Oral TabletPSN4ad20ef6-7bc6-4bdc-9fd9-cd5feb1e150f7
197528clonazepam 1 MG Oral TabletSCD4ad20ef6-7bc6-4bdc-9fd9-cd5feb1e150f7
197529clonazepam 2 MG Oral TabletSCD4ad20ef6-7bc6-4bdc-9fd9-cd5feb1e150f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-367-457161003674545 TABLET in 1 BOTTLE (71610-367-45) 45 tablet2019-11-200000-00-00NoNoCurrent