Clonazepam

Product NDC: 70518-2533
11-digit product format: 705182533
Labeler code: 70518
Product ID: 70518-2533_549f1520-0c2f-5dfe-e063-6394a90a59a0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clonazepam
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA077856
Marketing category: ANDA
Marketing start: 2020-01-09
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-2533	70518-2533-0	D	Discontinued by firm		2026-10-12
excluded package	package	70518-2533	70518-2533-3	D	Discontinued by firm		2026-10-12

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 · 7 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	70518-2533-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	70518-2533-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	70518-2533-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	70518-2533-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	70518-2533-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2024-11-09 02:27 UTC · source 2024-11-08	70518-2533-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	70518-2533-1	`367a005e9d99…`	`383a685ebd0f…`

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

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
A077856-001	CLONAZEPAM	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2006-06-28
A077856-002	CLONAZEPAM	CLONAZEPAM	1MG	TABLET / ORAL	AB	2006-06-28
A077856-003	CLONAZEPAM	CLONAZEPAM	2MG	TABLET / ORAL	AB	2006-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077856-001	AB
A077856-002	AB
A077856-003	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 · 129 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	A077856-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2006-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077856-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2006-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077856-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2006-06-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077856-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2006-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077856-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2006-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077856-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2006-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077856-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2006-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077856-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2006-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077856-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2006-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077856-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2006-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077856-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2006-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077856-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2006-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077856-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2006-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077856-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2006-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077856-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2006-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077856-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2006-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077856-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2006-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077856-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2006-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077856-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2006-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077856-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2006-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077856-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2006-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077856-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2006-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077856-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2006-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077856-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2006-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077856-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2006-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077856-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2006-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077856-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2006-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077856-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2006-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077856-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2006-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077856-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2006-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077856-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2006-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077856-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2006-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077856-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2006-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077856-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2006-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077856-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2006-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077856-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2006-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077856-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2006-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077856-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2006-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077856-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2006-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077856-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2006-06-28	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A077856-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077856-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077856-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077856-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077856-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077856-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077856-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077856-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077856-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077856-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077856-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077856-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077856-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077856-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077856-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077856-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077856-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077856-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077856-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077856-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077856-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077856-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077856-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077856-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077856-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077856-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077856-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077856-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077856-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077856-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077856-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077856-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077856-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077856-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077856-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077856-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077856-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077856-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077856-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077856-001	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
533a12a8-64fb-494f-a2a4-da1515ef1908	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70518-2533-0	2022-01-30	CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
70518-2533-0	2022-01-30	CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg Rx only
70518-2533-0	2022-01-30	CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg Rx only
70518-2533-1	2022-01-30	CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
70518-2533-1	2022-01-30	CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg Rx only
70518-2533-1	2022-01-30	CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg Rx only
70518-2533-0	2022-01-28	CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
70518-2533-0	2022-01-28	CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg Rx only
70518-2533-0	2022-01-28	CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg Rx only
70518-2533-1	2022-01-28	CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
70518-2533-1	2022-01-28	CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg Rx only
70518-2533-1	2022-01-28	CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70518-2533-1	EA - Each	70518-2533	d9b22461-446f-434f-aa76-96b24dabf9a0	1	2026-01-08
70518-2533-2	EA - Each	70518-2533	479b38ad-d08f-4a22-9927-4d389f00fe74	1	2026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-2533	CLONAZEPAM TABLET [REMEDYREPACK INC.]	10	Current NDC, Legacy NDC	20250321_533a12a8-64fb-494f-a2a4-da1515ef1908.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 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	f06dc5fc-94e0-496e-bdf0-11f2b6ffc786	2024-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	254a03c9-070c-40e6-83ac-524c1aec3b6b	2024-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	NuCare Pharmaceuticals,Inc.	19b1fe7b-8f7b-03b7-e063-6394a90a9ba5	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	154806ed-91af-fc7f-e063-6294a90ae0f4	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	5ec3df57-1137-4402-84e6-28dd76286427	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	2cb46dc0-a03e-42d7-ba67-22319598389f	2024-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	baa86bf1-75f3-44da-b67f-b6e4b5303f1e	2024-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	cd364371-d2af-4cb4-a5df-3d3149580e16	2024-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	d732be07-6eb7-48f2-b6cd-28baad46aca5	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	5f3a2f64-57ed-475c-9d8c-b2094bf1d79e	2023-10-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	5ae98718-9da5-4edc-8efb-67b212577548	2023-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	cc14bb7b-d0c8-4f41-bcd9-a0c860b45a43	2023-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Proficient Rx LP	645fb912-479c-46de-b99c-4ea341bfd9ba	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	6960e994-e9ea-4a4a-b674-7e6124d8b381	2023-05-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Proficient Rx LP	63286201-4b79-45b8-8f48-7e21dadc1408	2021-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856

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
70518-2533-0	70518253300	30 TABLET in 1 BLISTER PACK (70518-2533-0)	30 tablet	2020-01-09	0000-00-00	No	No	Current
70518-2533-1	70518253301	100 POUCH in 1 BOX (70518-2533-1) / 1 TABLET in 1 POUCH (70518-2533-2)	100 pouch	2020-04-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg Rx only	REMEDYREPACK INC.	2026-06-19	HUMAN PRESCRIPTION DRUG LABEL	15