Clonazepam

Product NDC
71610-863
11-digit product format
716100863
Labeler code
71610
Product ID
71610-863_26e544ba-44b8-cc65-e063-6394a90a2d64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077856
Marketing category
ANDA
Marketing start
2018-02-15
Substance
CLONAZEPAM
Active strength
.5 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 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
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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-2884e616aacf4f…
2026-09-14 22:38:342026-08A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-2884e616aacf4f…
2026-09-14 22:38:342026-08A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-2884e616aacf4f…
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…

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 22:38:342026-08A077856-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077856-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077856-003AB184e616aacf4f…
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…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Clonazepam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONAZEPAM.5 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
263f99eb-9744-5601-e063-6394a90a47b1Available 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
71610-863-10Clonazepam10 in 1 BOTTLETABLET102
71610-863-15Clonazepam15 in 1 BOTTLETABLET152
71610-863-20Clonazepam20 in 1 BOTTLETABLET202
71610-863-28Clonazepam28 in 1 BOTTLETABLET282
71610-863-30Clonazepam30 in 1 BOTTLETABLET302
71610-863-45Clonazepam45 in 1 BOTTLETABLET452
71610-863-46Clonazepam56 in 1 BOTTLETABLET562
71610-863-53Clonazepam60 in 1 BOTTLETABLET602
71610-863-54Clonazepam84 in 1 BOTTLETABLET842
71610-863-55Clonazepam75 in 1 BOTTLETABLET752
71610-863-60Clonazepam90 in 1 BOTTLETABLET902
71610-863-70Clonazepam120 in 1 BOTTLETABLET1202
71610-863-80Clonazepam180 in 1 BOTTLETABLET1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-863-10EA - Each71610-863721f6ecb-48c5-4fe3-b169-7ebaf34cac2112025-02-10
71610-863-15EA - Each71610-8633fbcc903-627d-4519-9466-0570564174e012025-02-10
71610-863-20EA - Each71610-863efdd9973-62e7-4be2-bb31-e62d78a447fe12025-02-10
71610-863-28EA - Each71610-86367d18265-b015-433d-a1ac-98b3b4b9c28512025-02-10
71610-863-30EA - Each71610-863def87992-1a3d-47c8-a916-eb107bc877e712025-02-10
71610-863-45EA - Each71610-8637c3520a0-b430-4a90-903d-80caf6b1431e12025-02-10
71610-863-46EA - Each71610-86389dc3aa4-f85f-42d0-aa4e-f38fd753c2b412025-02-10
71610-863-53EA - Each71610-863b76a75e8-f9df-4b2c-8b90-9272e07b47ad12025-02-10
71610-863-54EA - Each71610-86394bc4ac6-5022-494d-b844-c9d2d6bb675c12025-02-10
71610-863-55EA - Each71610-86346feda0e-4e62-420b-94f6-c95930d455bf12025-02-10
71610-863-70EA - Each71610-863f1c86904-1345-4a2e-9236-c2b907054f3512025-02-10
71610-863-80EA - Each71610-86374598680-596d-45cd-933f-062a77eaee1b12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-863CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]2Current NDC, 13 package rows20241116_263f99eb-9744-5601-e063-6394a90a47b1.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 2 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClonazepamCLONAZEPAMBryant Ranch Prepackf06dc5fc-94e0-496e-bdf0-11f2b6ffc7862024-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepack254a03c9-070c-40e6-83ac-524c1aec3b6b2024-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMNuCare Pharmaceuticals,Inc.19b1fe7b-8f7b-03b7-e063-6394a90a9ba52024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC154806ed-91af-fc7f-e063-6294a90ae0f42024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepack5ec3df57-1137-4402-84e6-28dd762864272024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC2cb46dc0-a03e-42d7-ba67-22319598389f2024-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepackbaa86bf1-75f3-44da-b67f-b6e4b5303f1e2024-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepackcd364371-d2af-4cb4-a5df-3d3149580e162024-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepackd732be07-6eb7-48f2-b6cd-28baad46aca52024-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepack5f3a2f64-57ed-475c-9d8c-b2094bf1d79e2023-10-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepack5ae98718-9da5-4edc-8efb-67b2125775482023-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepackcc14bb7b-d0c8-4f41-bcd9-a0c860b45a432023-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMProficient Rx LP645fb912-479c-46de-b99c-4ea341bfd9ba2023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepack6960e994-e9ea-4a4a-b674-7e6124d8b3812023-05-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMProficient Rx LP63286201-4b79-45b8-8f48-7e21dadc14082021-02-01Warnings, 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 TabletPSN263f99eb-9744-5601-e063-6394a90a47b12
197527clonazepam 0.5 MG Oral TabletSCD263f99eb-9744-5601-e063-6394a90a47b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-863-107161008631010 TABLET in 1 BOTTLE (71610-863-10) 10 tablet2024-11-04NoNoCurrent
71610-863-157161008631515 TABLET in 1 BOTTLE (71610-863-15) 15 tablet2024-11-04NoNoCurrent
71610-863-207161008632020 TABLET in 1 BOTTLE (71610-863-20) 20 tablet2024-11-13NoNoCurrent
71610-863-287161008632828 TABLET in 1 BOTTLE (71610-863-28) 28 tablet2024-11-13NoNoCurrent
71610-863-307161008633030 TABLET in 1 BOTTLE (71610-863-30) 30 tablet2024-11-04NoNoCurrent
71610-863-457161008634545 TABLET in 1 BOTTLE (71610-863-45) 45 tablet2024-11-04NoNoCurrent
71610-863-467161008634656 TABLET in 1 BOTTLE (71610-863-46) 56 tablet2024-11-04NoNoCurrent
71610-863-537161008635360 TABLET in 1 BOTTLE (71610-863-53) 60 tablet2024-11-04NoNoCurrent
71610-863-547161008635484 TABLET in 1 BOTTLE (71610-863-54) 84 tablet2024-11-13NoNoCurrent
71610-863-557161008635575 TABLET in 1 BOTTLE (71610-863-55) 75 tablet2024-11-13NoNoCurrent
71610-863-607161008636090 TABLET in 1 BOTTLE (71610-863-60) 90 tablet2024-11-04NoNoCurrent
71610-863-7071610086370120 TABLET in 1 BOTTLE (71610-863-70) 120 tablet2024-11-04NoNoCurrent
71610-863-8071610086380180 TABLET in 1 BOTTLE (71610-863-80) 180 tablet2024-11-04NoNoCurrent