Clonazepam

Product NDC: 68788-7738
11-digit product format: 687887738
Labeler code: 68788
Product ID: 68788-7738_3c3f5be0-7b58-432f-bdd4-9e2cdb948144
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clonazepam
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA077147
Marketing category: ANDA
Marketing start: 2020-07-01
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: 2023-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-7738		D	Discontinued by firm	2026-10-20
excluded package	package	68788-7738	68788-7738-2	D	Discontinued by firm	2026-10-20
excluded package	package	68788-7738	68788-7738-3	D	Discontinued by firm	2026-10-20
excluded package	package	68788-7738	68788-7738-6	D	Discontinued by firm	2026-10-20
excluded package	package	68788-7738	68788-7738-8	D	Discontinued by firm	2026-10-20
excluded package	package	68788-7738	68788-7738-9	D	Discontinued by firm	2026-10-20

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077147-001	CLONAZEPAM	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02
A077147-002	CLONAZEPAM	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02
A077147-003	CLONAZEPAM	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077147-001	AB
A077147-002	AB
A077147-003	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 · 132 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
2026-10-15 13:18:30	2026-09	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A077147-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077147-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077147-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077147-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077147-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077147-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077147-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077147-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077147-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077147-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077147-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077147-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077147-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077147-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077147-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077147-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077147-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077147-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077147-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077147-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077147-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077147-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077147-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077147-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077147-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077147-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077147-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077147-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077147-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077147-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077147-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077147-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077147-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077147-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077147-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077147-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077147-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077147-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077147-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077147-001	AB	1	`79d66fd596c7…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7738	CLONAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]	6	Legacy NDC	20250308_2dc15db1-9dff-4be9-8e73-35a01c5aea32.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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonazepam	CLONAZEPAM	Proficient Rx LP	d65c9a1e-f2f4-46d2-9b28-ba0e5c67e542	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147
Clonazepam	CLONAZEPAM	Proficient Rx LP	4dcb6785-e16b-4692-89b3-f905979ca5ae	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	c68420a9-b646-4a4f-99f7-43d652312eb0	2018-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7738-2	68788773802	20 TABLET in 1 BOTTLE, PLASTIC (68788-7738-2)	20 tablet	2020-07-01	0000-00-00	No	No	Current
68788-7738-3	68788773803	30 TABLET in 1 BOTTLE, PLASTIC (68788-7738-3)	30 tablet	2020-07-01	0000-00-00	No	No	Current
68788-7738-6	68788773806	60 TABLET in 1 BOTTLE, PLASTIC (68788-7738-6)	60 tablet	2020-07-01	0000-00-00	No	No	Current
68788-7738-8	68788773808	28 TABLET in 1 BOTTLE, PLASTIC (68788-7738-8)	28 tablet	2020-07-01	0000-00-00	No	No	Current
68788-7738-9	68788773809	90 TABLET in 1 BOTTLE, PLASTIC (68788-7738-9)	90 tablet	2020-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonazepam Tablets, USP Rx only	Preferred Pharmaceuticals, Inc.	2025-03-05	HUMAN PRESCRIPTION DRUG LABEL	6