Clonazepam

Product NDC
71335-0022
Requested package NDC
71335-0022-2
11-digit product format
713350022
Labeler code
71335
Product ID
71335-0022_4d7caa37-bb59-488b-91c8-db7a6d5a7f87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077147
Marketing category
ANDA
Marketing start
2011-06-03
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 1.

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
A077147-001CLONAZEPAMCLONAZEPAM0.5MGTABLET / ORALAB2005-05-02
A077147-002CLONAZEPAMCLONAZEPAM1MGTABLET / ORALAB2005-05-02
A077147-003CLONAZEPAMCLONAZEPAM2MGTABLET / ORALAB2005-05-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077147-001AB
A077147-002AB
A077147-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077147-001CLONAZEPAM0.5MGTABLET / ORALAB2005-05-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077147-002CLONAZEPAM1MGTABLET / ORALAB2005-05-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077147-003CLONAZEPAM2MGTABLET / ORALAB2005-05-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077147-001CLONAZEPAM0.5MGTABLET / ORALAB2005-05-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077147-002CLONAZEPAM1MGTABLET / ORALAB2005-05-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077147-003CLONAZEPAM2MGTABLET / ORALAB2005-05-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077147-001CLONAZEPAM0.5MGTABLET / ORALAB2005-05-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077147-002CLONAZEPAM1MGTABLET / ORALAB2005-05-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077147-003CLONAZEPAM2MGTABLET / ORALAB2005-05-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077147-001CLONAZEPAM0.5MGTABLET / ORALAB2005-05-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077147-002CLONAZEPAM1MGTABLET / ORALAB2005-05-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077147-003CLONAZEPAM2MGTABLET / ORALAB2005-05-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077147-001CLONAZEPAM0.5MGTABLET / ORALAB2005-05-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077147-002CLONAZEPAM1MGTABLET / ORALAB2005-05-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077147-003CLONAZEPAM2MGTABLET / ORALAB2005-05-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077147-001CLONAZEPAM0.5MGTABLET / ORALAB2005-05-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077147-002CLONAZEPAM1MGTABLET / ORALAB2005-05-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077147-003CLONAZEPAM2MGTABLET / ORALAB2005-05-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077147-001CLONAZEPAM0.5MGTABLET / ORALAB2005-05-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077147-002CLONAZEPAM1MGTABLET / ORALAB2005-05-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077147-003CLONAZEPAM2MGTABLET / ORALAB2005-05-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077147-001CLONAZEPAM0.5MGTABLET / ORALAB2005-05-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077147-002CLONAZEPAM1MGTABLET / ORALAB2005-05-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077147-003CLONAZEPAM2MGTABLET / ORALAB2005-05-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077147-001CLONAZEPAM0.5MGTABLET / ORALAB2005-05-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077147-002CLONAZEPAM1MGTABLET / ORALAB2005-05-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077147-003CLONAZEPAM2MGTABLET / ORALAB2005-05-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077147-001CLONAZEPAM0.5MGTABLET / ORALAB2005-05-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A077147-002CLONAZEPAM1MGTABLET / ORALAB2005-05-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A077147-003CLONAZEPAM2MGTABLET / ORALAB2005-05-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077147-001CLONAZEPAM0.5MGTABLET / ORALAB2005-05-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077147-002CLONAZEPAM1MGTABLET / ORALAB2005-05-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077147-003CLONAZEPAM2MGTABLET / ORALAB2005-05-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077147-001CLONAZEPAM0.5MGTABLET / ORALAB2005-05-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077147-002CLONAZEPAM1MGTABLET / ORALAB2005-05-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077147-003CLONAZEPAM2MGTABLET / ORALAB2005-05-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077147-001CLONAZEPAM0.5MGTABLET / ORALAB2005-05-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077147-002CLONAZEPAM1MGTABLET / ORALAB2005-05-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077147-003CLONAZEPAM2MGTABLET / ORALAB2005-05-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077147-001CLONAZEPAM0.5MGTABLET / ORALAB2005-05-028072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077147-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077147-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077147-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077147-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077147-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077147-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077147-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077147-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077147-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077147-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077147-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077147-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077147-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077147-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077147-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077147-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077147-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077147-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077147-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077147-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077147-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077147-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077147-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077147-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077147-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077147-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077147-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077147-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077147-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077147-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077147-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077147-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077147-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077147-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077147-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077147-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077147-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077147-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077147-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077147-001AB18072bd15b7f6…

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
4b5240a8-9e87-4664-8698-596a144d6d28Available 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
71335-0022-0Clonazepam100 in 1 BOTTLETABLET10017
71335-0022-1Clonazepam20 in 1 BOTTLETABLET2017
71335-0022-2Clonazepam30 in 1 BOTTLETABLET3017
71335-0022-3Clonazepam60 in 1 BOTTLETABLET6017
71335-0022-4Clonazepam90 in 1 BOTTLETABLET9017
71335-0022-5Clonazepam120 in 1 BOTTLETABLET12017
71335-0022-6Clonazepam180 in 1 BOTTLETABLET18017
71335-0022-7Clonazepam84 in 1 BOTTLETABLET8417
71335-0022-8Clonazepam28 in 1 BOTTLETABLET2817
71335-0022-9Clonazepam56 in 1 BOTTLETABLET5617

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0022-0EA - Each71335-0022141a21cb-f97e-420f-882b-053c30b4109212018-03-08
71335-0022-1EA - Each71335-00226a5d7ce3-1d86-425c-9595-677459a0d92512018-03-08
71335-0022-2EA - Each71335-0022d7e379aa-c1a8-44a6-92b6-a1209e71744b12018-03-08
71335-0022-3EA - Each71335-0022b7a5e641-4764-4927-97c3-9d13033c8a2e12018-03-08
71335-0022-4EA - Each71335-00225c3d52a4-98e0-4b86-97d4-be5e6de5395e12018-03-08
71335-0022-5EA - Each71335-0022f51aa8bb-0ab8-4800-b6f6-964d2e7f2b5e12018-03-08
71335-0022-6EA - Each71335-002216602d3c-5739-446c-b4b4-dd0ae66f353c12018-03-08
71335-0022-7EA - Each71335-00220a8a44f5-df20-4e6e-9fb2-46d5ff07698012018-03-08
71335-0022-8EA - Each71335-0022290c3894-5b0c-4378-bfdc-baeaf00d4ec412018-03-08
71335-0022-9EA - Each71335-00224ebf8c91-3567-4b56-af6a-ea71a4539fcc12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0022CLONAZEPAM TABLET [BRYANT RANCH PREPACK]17Current NDC, Legacy NDC, 10 package rows20240510_4b5240a8-9e87-4664-8698-596a144d6d28.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 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClonazepamCLONAZEPAMREMEDYREPACK INC.874b0395-fecb-446a-966f-6ecbb23f1ff62026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077147
application number: ANDA077147
ClonazepamCLONAZEPAMREMEDYREPACK INC.3aa9c3eb-3a0a-4e8b-af68-4f87d87194dd2026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077147
application number: ANDA077147
ClonazepamCLONAZEPAMREMEDYREPACK INC.00f323c0-e007-40df-ae7f-e6b3c7ba0aa82026-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077147
application number: ANDA077147
ClonazepamCLONAZEPAMREMEDYREPACK INC.a4185456-68f9-47d4-9952-fcdef86989db2026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077147
application number: ANDA077147
ClonazepamCLONAZEPAMREMEDYREPACK INC.095a80b0-09f9-4bd1-b377-5212d7c966ba2026-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077147
application number: ANDA077147
ClonazepamCLONAZEPAMPD-Rx Pharmaceuticals, Inc.9ee4e019-6a99-4aac-84b0-9aae597815a72025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077147
application number: ANDA077147
ClonazepamCLONAZEPAMPD-Rx Pharmaceuticals, Inc.c707caa1-d6fd-4790-9a64-f749bf93ef182025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077147
application number: ANDA077147
ClonazepamCLONAZEPAMPD-Rx Pharmaceuticals, Inc.1ce88d2c-70f7-427b-8787-4afd9ce6f71c2025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077147
application number: ANDA077147
ClonazepamCLONAZEPAMA-S Medication Solutions28675dd6-b952-4e71-b0a3-b701ad6b63442025-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077147
application number: ANDA077147
ClonazepamCLONAZEPAMSt Marys Medical Park Pharmacy31a7ed52-48a6-1c87-e054-00144ff88e882025-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077147
application number: ANDA077147
ClonazepamCLONAZEPAMAdvanced Rx of Tennessee, LLC04db8e8c-38f9-0c4a-e063-6394a90a93f02024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077147
application number: ANDA077147
ClonazepamCLONAZEPAMAdvanced Rx Pharmacy of Tennessee, LLCb9309a1a-a794-2f62-e053-2a95a90a7c342024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077147
application number: ANDA077147
ClonazepamCLONAZEPAMAdvanced Rx Pharmacy of Tennessee, LLCbe383e56-d71f-7699-e053-2995a90a50c12024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077147
application number: ANDA077147
ClonazepamCLONAZEPAMNuCare Pharmaceuticals,Inc.555061d4-276a-4716-e054-00144ff88e882024-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077147
application number: ANDA077147
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC7b0d716c-8f51-47a7-8bf2-07c6f9732a052024-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077147
application number: ANDA077147
ClonazepamCLONAZEPAMNuCare Pharmaceuticals,Inc.a4882077-694d-d46c-e053-2a95a90a217d2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077147
application number: ANDA077147
ClonazepamCLONAZEPAMBryant Ranch Prepack213c0120-507c-4c39-8aa4-3377f0b06d742024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077147
application number: ANDA077147
ClonazepamCLONAZEPAMBryant Ranch Prepack4b5240a8-9e87-4664-8698-596a144d6d282024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077147
application number: ANDA077147
ndc (package): 71335-0022-2
ndc (product): 71335-0022
ndc11 (package): 71335002202
ClonazepamCLONAZEPAMBryant Ranch Prepack9a4d3762-cfeb-4ffb-9c9e-40627cc4df712024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077147
application number: ANDA077147
ClonazepamCLONAZEPAMAccord Healthcare Inc.ebc11109-e7bf-452d-b675-4b3236d541642024-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077147
application number: ANDA077147

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197528clonazePAM 1 MG Oral TabletPSN4b5240a8-9e87-4664-8698-596a144d6d2817
197528clonazepam 1 MG Oral TabletSCD4b5240a8-9e87-4664-8698-596a144d6d2817

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0022-27133500220230 TABLET in 1 BOTTLE (71335-0022-2) 30 tablet2018-02-130000-00-00NoNoCurrent