Clonazepam

Product NDC: 68788-8473
Requested package NDC: 68788-8473-6
11-digit product format: 687888473
Labeler code: 68788
Product ID: 68788-8473_e5c4af7a-69eb-498e-99a9-fe539c76187d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonazepam
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA075468
Marketing category: ANDA
Marketing start: 2023-06-30
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075468-001	CLONAZEPAM	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2000-10-06
A075468-002	CLONAZEPAM	CLONAZEPAM	1MG	TABLET / ORAL	AB	2000-10-06
A075468-003	CLONAZEPAM	CLONAZEPAM	2MG	TABLET / ORAL	AB	2000-10-06
A075468-004	CLONAZEPAM	CLONAZEPAM	0.25MG	TABLET / ORAL		2026-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075468-001	AB
A075468-002	AB
A075468-003	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 4 · 131 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
2026-09-14 22:38:34	2026-08	A075468-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2000-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075468-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2000-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075468-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2000-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075468-004	CLONAZEPAM	0.25MG	TABLET / ORAL		2026-06-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075468-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2000-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075468-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2000-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075468-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2000-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075468-004	CLONAZEPAM	0.25MG	TABLET / ORAL		2026-06-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075468-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2000-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075468-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2000-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075468-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2000-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075468-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2000-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075468-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2000-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075468-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2000-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075468-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2000-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075468-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2000-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075468-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2000-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075468-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2000-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075468-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2000-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075468-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2000-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075468-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2000-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075468-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2000-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075468-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2000-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075468-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2000-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075468-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2000-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075468-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2000-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075468-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2000-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075468-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2000-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075468-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2000-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075468-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2000-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075468-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2000-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075468-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2000-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075468-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2000-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075468-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2000-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075468-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2000-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075468-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2000-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075468-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2000-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075468-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2000-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075468-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2000-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075468-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2000-10-06	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075468-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075468-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075468-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075468-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075468-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075468-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075468-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075468-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075468-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075468-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075468-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075468-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075468-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075468-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075468-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075468-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075468-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075468-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075468-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075468-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075468-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075468-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075468-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075468-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075468-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075468-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075468-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075468-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075468-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075468-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075468-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075468-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075468-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075468-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075468-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075468-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075468-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075468-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075468-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075468-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLONAZEPAM	1 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197528	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
f803fefc-69ff-4963-950b-48c13998bc2c	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	SPL version
68788-8473-2	Clonazepam	20 in 1 BOTTLE	TABLET	20	4
68788-8473-3	Clonazepam	30 in 1 BOTTLE	TABLET	30	4
68788-8473-6	Clonazepam	60 in 1 BOTTLE	TABLET	60	4
68788-8473-8	Clonazepam	28 in 1 BOTTLE	TABLET	28	4
68788-8473-9	Clonazepam	90 in 1 BOTTLE	TABLET	90	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8473-2	EA - Each	68788-8473	b43ed606-02ea-44f1-a4fe-52e709923a84	1	2023-08-08
68788-8473-3	EA - Each	68788-8473	27ebdf1f-4211-45b1-8803-35e6a04d8f6c	1	2023-08-08
68788-8473-6	EA - Each	68788-8473	1e30b8ac-8cd1-42cb-b367-90b23fac0627	1	2023-08-08
68788-8473-8	EA - Each	68788-8473	8db4e44a-2d66-498f-903f-fe76cc21924d	1	2023-08-08
68788-8473-9	EA - Each	68788-8473	b851bf63-ee58-4293-9885-256ada84d9af	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8473	CLONAZEPAM TABLET [PREFERRED PHARMACEUTICALS INC.]	3	Current NDC, 5 package rows	20250308_f803fefc-69ff-4963-950b-48c13998bc2c.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	9c3b1b37-8bc0-427a-8c7a-14da7bd49a7f	2026-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075468 application number: ANDA075468
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	19475112-60da-4d53-b330-70afe28ebaf3	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075468 application number: ANDA075468
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	c4b87c17-efcd-4b66-96e7-159a04c808b5	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075468 application number: ANDA075468
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	8bb69bbe-07e1-4123-9b70-fde78d1d0a34	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075468 application number: ANDA075468
Clonazepam	CLONAZEPAM	Advagen Pharma Ltd	30d674f9-f1b3-4c2d-a8e9-3bc8e476f1ec	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075468 application number: ANDA075468
Clonazepam	CLONAZEPAM	Unit Dose Solutions, Inc.	54789918-cc0c-7090-e063-6394a90aeba7	2026-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075468 application number: ANDA075468
Clonazepam	CLONAZEPAM	Preferred Pharmaceuticals Inc.	f803fefc-69ff-4963-950b-48c13998bc2c	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075468 application number: ANDA075468 ndc (package): 68788-8473-6 ndc (product): 68788-8473 ndc11 (package): 68788847306
Clonazepam	CLONAZEPAM	Northstar Rx LLC	017534e6-49ff-45f3-b88f-2f34cf0cf8fd	2026-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075468 application number: ANDA075468
Clonazepam	CLONAZEPAM	Coupler LLC	2e970dc2-cd78-bcdf-e063-6294a90ad3e0	2025-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075468 application number: ANDA075468
Clonazepam	CLONAZEPAM	Coupler LLC	2cdb55a7-54e4-17b6-e063-6294a90ac827	2025-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075468 application number: ANDA075468
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	8891c5aa-f42a-4206-92b9-f0ed0631dfcb	2024-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075468 application number: ANDA075468
Clonazepam	CLONAZEPAM	Clinical Solutions Wholesale, LLC	401cb3c0-4a5b-4ff9-baea-53095e60263d	2024-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075468 application number: ANDA075468

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
197528	clonazePAM 1 MG Oral Tablet	PSN	f803fefc-69ff-4963-950b-48c13998bc2c	4
197528	clonazepam 1 MG Oral Tablet	SCD	f803fefc-69ff-4963-950b-48c13998bc2c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-8473-6	68788847306	60 TABLET in 1 BOTTLE (68788-8473-6)	60 tablet	2023-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonazepam Tablets, USP Rx only	Preferred Pharmaceuticals Inc.	2026-03-31	HUMAN PRESCRIPTION DRUG LABEL	4