Clonazepam

Product NDC: 55700-564
Requested package NDC: 55700-564-30
11-digit product format: 557000564
Labeler code: 55700
Product ID: 55700-564_cad07538-1ed8-4943-a521-5aaaee42d5ac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonazepam
Dosage form: TABLET
Route: ORAL
Labeler: Lake Erie Medical DBA Quality Care Products LLC
Application: ANDA074569
Marketing category: ANDA
Marketing start: 2017-12-08
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55700-564	55700-564-30	D	Discontinued by firm		2026-08-17

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55700-564	55700-564-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A074569-001	CLONAZEPAM	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10
A074569-002	CLONAZEPAM	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10
A074569-003	CLONAZEPAM	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074569-001	AB
A074569-002	AB
A074569-003	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 · 126 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	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074569-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1996-09-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074569-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1996-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074569-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1996-09-10	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A074569-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074569-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074569-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074569-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074569-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074569-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074569-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074569-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074569-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074569-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074569-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074569-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074569-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074569-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074569-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074569-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074569-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074569-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074569-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074569-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074569-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074569-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074569-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074569-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074569-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074569-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074569-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074569-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074569-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074569-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074569-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074569-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074569-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074569-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074569-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074569-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074569-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074569-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074569-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074569-001	AB	1	`1e350fbaab3a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-564-01	EA - Each	55700-564	75e3549f-6e9b-4214-9fb2-1d798f88ee31	1	2018-01-12
55700-564-30	EA - Each	55700-564	04690984-fe33-4871-a667-cf066a31cbdd	1	2018-01-12
55700-564-60	EA - Each	55700-564	f0e1c533-ca3c-4247-9bc6-5e39d468e413	1	2018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55700-564	CLONAZEPAM TABLET [QUALITY CARE PRODUCTS, LLC]	9	Legacy NDC	20241219_ceef15ee-93ac-400f-ad73-b5d421f56d8c.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	64bb2cdf-f57d-4a41-a5bf-ee77b6e64d06	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074569 application number: ANDA074569
Clonazepam	CLONAZEPAM	Coupler LLC	54d6e348-4c51-221e-e063-6294a90a9b7d	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074569 application number: ANDA074569
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	b1c53213-9f84-4389-b6dc-3dc26d9a6364	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074569 application number: ANDA074569
Clonazepam	CLONAZEPAM	A-S Medication Solutions	b3c9d04a-431f-4cec-a809-847dfb8de736	2024-05-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074569 application number: ANDA074569
Clonazepam	CLONAZEPAM	Clinical Solutions Wholesale, LLC	429a15d1-1675-42cc-97f1-c49b03747416	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074569 application number: ANDA074569
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	73125f86-ce24-44c0-a2b1-a5d12a607a94	2023-11-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074569 application number: ANDA074569
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	6be64dc3-3748-477c-8800-2c2175309c73	2023-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074569 application number: ANDA074569
Clonazepam	CLONAZEPAM	Teva Pharmaceuticals USA, Inc.	8069b1a0-7c06-4252-b44e-e2eef065d9b8	2023-04-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074569 application number: ANDA074569
Clonazepam	CLONAZEPAM	Proficient Rx LP	56175c25-3fde-43ea-89bf-22dcf3278b6b	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074569 application number: ANDA074569

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
55700-564-30	55700056430	30 TABLET in 1 BOTTLE (55700-564-30)	30 tablet	2017-12-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLONAZEPAM TABLETS USP CIV Rx only	Quality Care Products, LLC	2024-12-17	HUMAN PRESCRIPTION DRUG LABEL	9