Clonazepam

Product NDC
49884-309
11-digit product format
498840309
Labeler code
49884
Product ID
49884-309_cb847105-dbbe-4e7a-ab2b-ad0731638ce6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA077171
Marketing category
ANDA
Marketing start
2005-08-05
Substance
CLONAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproduct49884-309IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage49884-30949884-309-02IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077171-001CLONAZEPAMCLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-03
A077171-002CLONAZEPAMCLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-03
A077171-003CLONAZEPAMCLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-03
A077171-004CLONAZEPAMCLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORALABRS2005-08-03
A077171-005CLONAZEPAMCLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A077171-001AB
A077171-002AB
A077171-003AB
A077171-004AB
A077171-005AB

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 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077171-001CLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-03caaa826d4ba7…
2026-08-18 06:07:402026-07A077171-002CLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-03caaa826d4ba7…
2026-08-18 06:07:402026-07A077171-003CLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-03caaa826d4ba7…
2026-08-18 06:07:402026-07A077171-004CLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORALABRS2005-08-03caaa826d4ba7…
2026-08-18 06:07:402026-07A077171-005CLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077171-001CLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077171-002CLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077171-003CLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077171-004CLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORALABRS2005-08-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077171-005CLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077171-001CLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077171-002CLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077171-003CLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077171-004CLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORALABRS2005-08-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077171-005CLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077171-001CLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077171-002CLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077171-003CLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077171-004CLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORALABRS2005-08-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077171-005CLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077171-001CLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077171-002CLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077171-003CLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077171-004CLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORALABRS2005-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077171-005CLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077171-001CLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077171-002CLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077171-003CLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077171-004CLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORALABRS2005-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077171-005CLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077171-001CLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077171-002CLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077171-003CLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077171-004CLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORALABRS2005-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077171-005CLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077171-001CLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077171-002CLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077171-003CLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077171-004CLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORALABRS2005-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077171-005CLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2005-08-032680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077171-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077171-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077171-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077171-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077171-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077171-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077171-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077171-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077171-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077171-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077171-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077171-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077171-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077171-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077171-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077171-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077171-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077171-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077171-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077171-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077171-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077171-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077171-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077171-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077171-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077171-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077171-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077171-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077171-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077171-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077171-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077171-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077171-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077171-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077171-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077171-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077171-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077171-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077171-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077171-005AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
Clonazepam
Listing expiration
2027-12-31

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 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349194Internal RxNorm lookup
349195Internal RxNorm lookup
349196Internal RxNorm lookup
349197Internal RxNorm lookup
349198Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1aef0069-80ea-483d-ac70-c8d485462c5bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f8e2a02d-e7b1-29aa-eb39-98a679441d91Product name320190927
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
dc4336d1-53d4-d410-38d3-71aa2ce4749bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-309-02Clonazepam60 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING6027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-309-02EA - Each49884-309935dd973-a525-40b2-a295-7c06ec5c25da12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-309CLONAZEPAM TABLET, ORALLY DISINTEGRATING [ENDO USA, INC.]22Current NDC, Legacy NDC, 1 package rows20241212_1aef0069-80ea-483d-ac70-c8d485462c5b.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
ClonazepamCLONAZEPAMPar Health USA, LLC1aef0069-80ea-483d-ac70-c8d485462c5b2025-10-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077171
application number: ANDA077171
ndc (product): 49884-309

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349194clonazePAM 0.125 MG Disintegrating Oral TabletPSN1aef0069-80ea-483d-ac70-c8d485462c5b27
349195clonazePAM 0.25 MG Disintegrating Oral TabletPSN1aef0069-80ea-483d-ac70-c8d485462c5b27
349198clonazePAM 0.5 MG Disintegrating Oral TabletPSN1aef0069-80ea-483d-ac70-c8d485462c5b27
349196clonazePAM 1 MG Disintegrating Oral TabletPSN1aef0069-80ea-483d-ac70-c8d485462c5b27
349197clonazePAM 2 MG Disintegrating Oral TabletPSN1aef0069-80ea-483d-ac70-c8d485462c5b27
349194clonazepam 0.125 MG Disintegrating Oral TabletSCD1aef0069-80ea-483d-ac70-c8d485462c5b27
349195clonazepam 0.25 MG Disintegrating Oral TabletSCD1aef0069-80ea-483d-ac70-c8d485462c5b27
349198clonazepam 0.5 MG Disintegrating Oral TabletSCD1aef0069-80ea-483d-ac70-c8d485462c5b27
349196clonazepam 1 MG Disintegrating Oral TabletSCD1aef0069-80ea-483d-ac70-c8d485462c5b27
349197clonazepam 2 MG Disintegrating Oral TabletSCD1aef0069-80ea-483d-ac70-c8d485462c5b27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49884-309-024988403090260 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-309-02) 2005-08-050000-00-00NoNoCurrent