Clonazepam

Product NDC: 0093-9291
11-digit product format: 000939291
Labeler code: 0093
Product ID: 0093-9291_a2f2eb5b-f890-4d6d-b728-5f63eb7dc11c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonazepam
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA077194
Marketing category: ANDA
Marketing start: 2022-03-02
Substance: CLONAZEPAM
Active strength: .25 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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077194-001	CLONAZEPAM	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10
A077194-002	CLONAZEPAM	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10
A077194-003	CLONAZEPAM	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10
A077194-004	CLONAZEPAM	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10
A077194-005	CLONAZEPAM	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077194-001	AB
A077194-002	AB
A077194-003	AB
A077194-004	AB
A077194-005	AB

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077194-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077194-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077194-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077194-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077194-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077194-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077194-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077194-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077194-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077194-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077194-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077194-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077194-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077194-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077194-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077194-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077194-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077194-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077194-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077194-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077194-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077194-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077194-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077194-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077194-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077194-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077194-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077194-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077194-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077194-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077194-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077194-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077194-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077194-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077194-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077194-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077194-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077194-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077194-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077194-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-08-10	`2680178bc6a6…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077194-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077194-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077194-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077194-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077194-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077194-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077194-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077194-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077194-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077194-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077194-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077194-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077194-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077194-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077194-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077194-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077194-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077194-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077194-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077194-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077194-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077194-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077194-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077194-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077194-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077194-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077194-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077194-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077194-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077194-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077194-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077194-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077194-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077194-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077194-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077194-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077194-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077194-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077194-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077194-005	AB	1	`2680178bc6a6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLONAZEPAM	.25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5PE9FDE8GB	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
cb2e209e-e69b-422b-8abb-34df2bc92caa	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f8e2a02d-e7b1-29aa-eb39-98a679441d91	Product name	3	20190927
dc4336d1-53d4-d410-38d3-71aa2ce4749b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0093-9291-67	Clonazepam	1 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	1		8
0093-9291-67	Clonazepam	60 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	60		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-9291-67	EA - Each	0093-9291	0ae7aa91-be44-4e2a-978c-af00f7b9bc57	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-9291	CLONAZEPAM TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20240614_cb2e209e-e69b-422b-8abb-34df2bc92caa.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonazepam	CLONAZEPAM	Teva Pharmaceuticals USA, Inc.	cb2e209e-e69b-422b-8abb-34df2bc92caa	2024-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077194 application number: ANDA077194 ndc (product): 0093-9291

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5PE9FDE8GB	CLONAZEPAM	1622-61-3	CLONAZEPAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349194	clonazePAM 0.125 MG Disintegrating Oral Tablet	PSN	cb2e209e-e69b-422b-8abb-34df2bc92caa	8
349195	clonazePAM 0.25 MG Disintegrating Oral Tablet	PSN	cb2e209e-e69b-422b-8abb-34df2bc92caa	8
349198	clonazePAM 0.5 MG Disintegrating Oral Tablet	PSN	cb2e209e-e69b-422b-8abb-34df2bc92caa	8
349196	clonazePAM 1 MG Disintegrating Oral Tablet	PSN	cb2e209e-e69b-422b-8abb-34df2bc92caa	8
349197	clonazePAM 2 MG Disintegrating Oral Tablet	PSN	cb2e209e-e69b-422b-8abb-34df2bc92caa	8
349194	clonazepam 0.125 MG Disintegrating Oral Tablet	SCD	cb2e209e-e69b-422b-8abb-34df2bc92caa	8
349195	clonazepam 0.25 MG Disintegrating Oral Tablet	SCD	cb2e209e-e69b-422b-8abb-34df2bc92caa	8
349198	clonazepam 0.5 MG Disintegrating Oral Tablet	SCD	cb2e209e-e69b-422b-8abb-34df2bc92caa	8
349196	clonazepam 1 MG Disintegrating Oral Tablet	SCD	cb2e209e-e69b-422b-8abb-34df2bc92caa	8
349197	clonazepam 2 MG Disintegrating Oral Tablet	SCD	cb2e209e-e69b-422b-8abb-34df2bc92caa	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-9291-67	00093929167	60 BLISTER PACK in 1 CARTON (0093-9291-67) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	60 blister pack	2022-03-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonazepam Orally Disintegrating Tablets, USP CIV	Teva Pharmaceuticals USA, Inc.	2024-05-14	HUMAN PRESCRIPTION DRUG LABEL	8