Clonazepam

Product NDC
62135-771
11-digit product format
621350771
Labeler code
62135
Product ID
62135-771_09184e1a-1808-d656-e063-6294a90aa6f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA074925
Marketing category
ANDA
Marketing start
1997-09-30
Substance
CLONAZEPAM
Active strength
2 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 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
A074925-001CLONAZEPAMCLONAZEPAM0.5MGTABLET / ORALAB1997-09-30
A074925-002CLONAZEPAMCLONAZEPAM1MGTABLET / ORALAB1997-09-30
A074925-003CLONAZEPAMCLONAZEPAM2MGTABLET / ORALAB1997-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074925-001AB
A074925-002AB
A074925-003AB

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 06:07:402026-07A074925-001CLONAZEPAM0.5MGTABLET / ORALAB1997-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07A074925-002CLONAZEPAM1MGTABLET / ORALAB1997-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07A074925-003CLONAZEPAM2MGTABLET / ORALAB1997-09-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074925-001CLONAZEPAM0.5MGTABLET / ORALAB1997-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074925-002CLONAZEPAM1MGTABLET / ORALAB1997-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074925-003CLONAZEPAM2MGTABLET / ORALAB1997-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074925-001CLONAZEPAM0.5MGTABLET / ORAL1997-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074925-002CLONAZEPAM1MGTABLET / ORAL1997-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074925-003CLONAZEPAM2MGTABLET / ORAL1997-09-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074925-001CLONAZEPAM0.5MGTABLET / ORAL1997-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074925-002CLONAZEPAM1MGTABLET / ORAL1997-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074925-003CLONAZEPAM2MGTABLET / ORAL1997-09-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074925-001CLONAZEPAM0.5MGTABLET / ORAL1997-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074925-002CLONAZEPAM1MGTABLET / ORAL1997-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074925-003CLONAZEPAM2MGTABLET / ORAL1997-09-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074925-001CLONAZEPAM0.5MGTABLET / ORAL1997-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074925-002CLONAZEPAM1MGTABLET / ORAL1997-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074925-003CLONAZEPAM2MGTABLET / ORAL1997-09-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074925-001CLONAZEPAM0.5MGTABLET / ORAL1997-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074925-002CLONAZEPAM1MGTABLET / ORAL1997-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074925-003CLONAZEPAM2MGTABLET / ORAL1997-09-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074925-001CLONAZEPAM0.5MGTABLET / ORAL1997-09-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074925-002CLONAZEPAM1MGTABLET / ORAL1997-09-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074925-003CLONAZEPAM2MGTABLET / ORAL1997-09-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074925-001CLONAZEPAM0.5MGTABLET / ORAL1997-09-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074925-002CLONAZEPAM1MGTABLET / ORAL1997-09-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074925-003CLONAZEPAM2MGTABLET / ORAL1997-09-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074925-001CLONAZEPAM0.5MGTABLET / ORAL1997-09-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074925-002CLONAZEPAM1MGTABLET / ORAL1997-09-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074925-003CLONAZEPAM2MGTABLET / ORAL1997-09-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074925-001CLONAZEPAM0.5MGTABLET / ORAL1997-09-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A074925-002CLONAZEPAM1MGTABLET / ORAL1997-09-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A074925-003CLONAZEPAM2MGTABLET / ORAL1997-09-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074925-001CLONAZEPAM0.5MGTABLET / ORAL1997-09-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074925-002CLONAZEPAM1MGTABLET / ORAL1997-09-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074925-003CLONAZEPAM2MGTABLET / ORAL1997-09-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074925-001CLONAZEPAM0.5MGTABLET / ORAL1997-09-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074925-002CLONAZEPAM1MGTABLET / ORAL1997-09-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074925-003CLONAZEPAM2MGTABLET / ORAL1997-09-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074925-001CLONAZEPAM0.5MGTABLET / ORAL1997-09-301e350fbaab3a…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A074925-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074925-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074925-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074925-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074925-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074925-003AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A074925-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A074925-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A074925-003AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONAZEPAM2 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197527Internal RxNorm lookup
197528Internal RxNorm lookup
197529Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7b543f77-4388-4227-942f-7933f200b3a5Available 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
62135-771-90Clonazepam90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-771-90EA - Each62135-77170bff418-971a-4ece-99d6-353e0eb9fdd512023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-771CLONAZEPAM TABLET [CHARTWELL RX, LLC]1Current NDC, 1 package rows20231102_7b543f77-4388-4227-942f-7933f200b3a5.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClonazepamCLONAZEPAMChartwell RX, LLC7b543f77-4388-4227-942f-7933f200b3a52023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074925
application number: ANDA074925
ndc (product): 62135-771

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSN7b543f77-4388-4227-942f-7933f200b3a51
197528clonazePAM 1 MG Oral TabletPSN7b543f77-4388-4227-942f-7933f200b3a51
197529clonazePAM 2 MG Oral TabletPSN7b543f77-4388-4227-942f-7933f200b3a51
197527clonazepam 0.5 MG Oral TabletSCD7b543f77-4388-4227-942f-7933f200b3a51
197528clonazepam 1 MG Oral TabletSCD7b543f77-4388-4227-942f-7933f200b3a51
197529clonazepam 2 MG Oral TabletSCD7b543f77-4388-4227-942f-7933f200b3a51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-771-906213507719090 TABLET in 1 BOTTLE (62135-771-90) 90 tablet2023-10-29NoNoCurrent