Clonazepam

Product NDC: 71610-363
Requested package NDC: 71610-363-45
11-digit product format: 716100363
Labeler code: 71610
Product ID: 71610-363_4920f458-d8f5-4089-a4b4-8cdcfe210de3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clonazepam
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA077856
Marketing category: ANDA
Marketing start: 2018-02-15
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: 2020-12-31
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	71610-363	71610-363-45	I	Inactivated by FDA		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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	E	Excluded after deficient or non-compliant submission was not corrected	`fb8cb913e6d1…`	`eb8c232b6be0…`

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
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 · 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077856-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2006-06-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077856-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2006-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077856-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2006-06-28	`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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077856-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077856-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077856-001	AB	1	`1e350fbaab3a…`

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, Related label table
NDC	Related label
71610-363-15	CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
71610-363-28	CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
71610-363-30	CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
71610-363-45	CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
71610-363-46	CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
71610-363-53	CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
71610-363-60	CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
71610-363-70	CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
71610-363-75	CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
71610-363-80	CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71610-363-15	Clonazepam	15 in 1 BOTTLE, PLASTIC	TABLET	15	1
71610-363-28	Clonazepam	28 in 1 BOTTLE, PLASTIC	TABLET	28	1
71610-363-30	Clonazepam	30 in 1 BOTTLE, PLASTIC	TABLET	30	1
71610-363-45	Clonazepam	45 in 1 BOTTLE, PLASTIC	TABLET	45	1
71610-363-46	Clonazepam	56 in 1 BOTTLE, PLASTIC	TABLET	56	1
71610-363-53	Clonazepam	60 in 1 BOTTLE, PLASTIC	TABLET	60	1
71610-363-60	Clonazepam	90 in 1 BOTTLE, PLASTIC	TABLET	90	1
71610-363-70	Clonazepam	120 in 1 BOTTLE, PLASTIC	TABLET	120	1
71610-363-75	Clonazepam	150 in 1 BOTTLE, PLASTIC	TABLET	150	1
71610-363-80	Clonazepam	180 in 1 BOTTLE, PLASTIC	TABLET	180	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-363-15	EA - Each	71610-363	dde0ea7e-d9aa-4bee-b16b-3fef21c67e71	1	2020-01-03
71610-363-28	EA - Each	71610-363	15a04cc3-e436-4971-8680-562b1b0f210c	1	2020-01-03
71610-363-30	EA - Each	71610-363	95f08f67-ca65-4ef9-a84f-cb46cbfa876e	1	2020-01-03
71610-363-45	EA - Each	71610-363	b2214ba7-c77b-4353-a2df-1d59ec1ad701	1	2020-01-03
71610-363-46	EA - Each	71610-363	d20d17dc-d0b2-42d2-9695-199e7a7a0e6f	1	2020-01-03
71610-363-53	EA - Each	71610-363	f2432308-79b0-4587-ab2e-18afc5172ddf	1	2020-01-03
71610-363-60	EA - Each	71610-363	bb9676ec-2098-4877-83f9-2cc00c10c406	1	2020-01-03
71610-363-70	EA - Each	71610-363	9b28a3b9-77b8-41be-bddc-2f2478c8e1ec	1	2020-01-03
71610-363-75	EA - Each	71610-363	4c7fb9be-033b-4c4f-99ef-6ee5660753b4	1	2020-01-03
71610-363-80	EA - Each	71610-363	7b2d0df8-67bf-4fb6-a331-cba69bc0decd	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-363	CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 10 package rows	20191128_37666d94-0898-4656-9c08-f6d1f5491406.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 2 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	533a12a8-64fb-494f-a2a4-da1515ef1908	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Major Pharmaceuticals	34366dd2-432c-4fa9-8fab-832cca781b84	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Coupler LLC	511216c7-6878-f90a-e063-6394a90aaac8	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Cardinal Health 107, LLC	5ad315f2-fa09-4956-b931-f9966fb73e4e	2026-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Preferred Pharmaceuticals Inc.	2fe0d214-9c4d-4a0c-9024-c2076c092c1a	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Preferred Pharmaceuticals Inc.	87f362a7-cf66-4166-af51-ac2da473cf6b	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Preferred Pharmaceuticals Inc.	939dee35-3987-4ce2-9985-3751ceffa20e	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	AvPAK	f2662808-01c4-330c-e053-2a95a90aa335	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	PD-Rx Pharmaceuticals, Inc.	08d0a109-3307-47b5-8ff2-c0ad83e66f08	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	PD-Rx Pharmaceuticals, Inc.	9a74ea97-1c00-4d96-a06f-81c183943dc6	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	PD-Rx Pharmaceuticals, Inc.	ca79f244-7e6e-4612-af26-e6e5cefbd3a2	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Solco Healthcare LLC	4acbb7a9-4db5-4497-b8db-9f358b3f6fb4	2025-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	American Health Packaging	c13297e2-ae3e-4198-b7c8-55fd672436aa	2025-03-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Direct_Rx	fc75869c-cd6b-44a3-e053-6294a90a699e	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
CLONAZEPAM	CLONAZEPAM	DIRECT RX	a821f647-be5f-274c-e053-2a95a90a23ce	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	263f99eb-9744-5601-e063-6394a90a47b1	2024-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	66bf60fa-61ac-47a7-a081-36077af9007e	2024-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	b12661a6-2141-42a9-bcb0-c0aef81395ce	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	b83009c2-26ed-45fa-819e-164cdac264e6	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077856 application number: ANDA077856
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	96518266-8f75-4301-b8fd-d2995a7f486d	2024-08-06	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197528	clonazePAM 1 MG Oral Tablet	PSN	37666d94-0898-4656-9c08-f6d1f5491406	1
197528	clonazepam 1 MG Oral Tablet	SCD	37666d94-0898-4656-9c08-f6d1f5491406	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-363-45	71610036345	45 TABLET in 1 BOTTLE, PLASTIC (71610-363-45)	45 tablet	2019-11-18	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 CIV Rx only	Aphena Pharma Solutions - Tennessee, LLC	2019-11-26	HUMAN PRESCRIPTION DRUG LABEL	1