Clonazepam

Product NDC
17856-0133
Requested package NDC
17856-0133-1
11-digit product format
178560133
Labeler code
17856
Product ID
17856-0133_20fe4975-ff88-4030-b531-fb646af650d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA077147
Marketing category
ANDA
Marketing start
2018-07-18
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
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage17856-013317856-0133-1IInactivated 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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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
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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077147-001CLONAZEPAM0.5MGTABLET / ORALAB2005-05-02caaa826d4ba7…
2026-08-18 06:07:402026-07A077147-002CLONAZEPAM1MGTABLET / ORALAB2005-05-02caaa826d4ba7…
2026-08-18 06:07:402026-07A077147-003CLONAZEPAM2MGTABLET / ORALAB2005-05-02caaa826d4ba7…
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…

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 06:07:402026-07A077147-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077147-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077147-003AB1caaa826d4ba7…
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…

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
17856-0133-1Clonazepam100 in 1 BOX, UNIT-DOSETABLET1003
17856-0133-1Clonazepam1 in 1 POUCHTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0133CLONAZEPAM TABLET [ATLANTIC BIOLOGICALS CORP.]3Legacy NDC, 2 package rows20200330_7f7a5a78-ec40-428c-a922-24166dc74cdb.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
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
197527clonazePAM 0.5 MG Oral TabletPSN7f7a5a78-ec40-428c-a922-24166dc74cdb3
197527clonazepam 0.5 MG Oral TabletSCD7f7a5a78-ec40-428c-a922-24166dc74cdb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0133-117856013301100 POUCH in 1 BOX, UNIT-DOSE (17856-0133-1) > 1 TABLET in 1 POUCH100 pouch2020-03-270000-00-00NoNoCurrent