Clonazepam

Product NDC
43063-794
Requested package NDC
43063-794-60
11-digit product format
430630794
Labeler code
43063
Product ID
43063-794_415b681a-3c14-e26d-e063-6394a90a2fcb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
9ee4e019-6a99-4aac-84b0-9aae597815a7Available 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
43063-794-30Clonazepam30 in 1 BOTTLE, PLASTICTABLET3016
43063-794-60Clonazepam60 in 1 BOTTLE, PLASTICTABLET6016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-794-30EA - Each43063-7946b86dd3b-7b83-4b8c-a40c-6269aa41a43512017-11-06
43063-794-60EA - Each43063-79439670703-9ea9-4490-b806-e6799bac849f12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-794CLONAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 2 package rows20240608_9ee4e019-6a99-4aac-84b0-9aae597815a7.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
ndc (package): 43063-794-60
ndc (product): 43063-794
ndc11 (package): 43063079460
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
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 TabletPSN9ee4e019-6a99-4aac-84b0-9aae597815a716
197528clonazepam 1 MG Oral TabletSCD9ee4e019-6a99-4aac-84b0-9aae597815a716

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-794-604306307946060 TABLET in 1 BOTTLE, PLASTIC (43063-794-60) 60 tablet2017-10-100000-00-00NoNoCurrent