Clonazepam

Product NDC: 80425-0358
Requested package NDC: 80425-0358-3
11-digit product format: 804250358
Labeler code: 80425
Product ID: 80425-0358_2a99a670-af28-299d-e063-6294a90a05d2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clonazepam
Dosage form: TABLET
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA077147
Marketing category: ANDA
Marketing start: 2023-09-08
Substance: CLONAZEPAM
Active strength: .5 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 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 · 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	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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`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	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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077147-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077147-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077147-001	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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLONAZEPAM	.5 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
197527	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
04db8e8c-38f9-0c4a-e063-6394a90a93f0	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
80425-0358-1	Clonazepam	30 in 1 BOTTLE, PLASTIC	TABLET	30	2
80425-0358-2	Clonazepam	60 in 1 BOTTLE, PLASTIC	TABLET	60	2
80425-0358-3	Clonazepam	90 in 1 BOTTLE, PLASTIC	TABLET	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0358-1	EA - Each	80425-0358	18c1b162-1578-45af-bca9-e2348a4f344c	1	2023-10-16
80425-0358-2	EA - Each	80425-0358	0110193a-0a55-45ee-a8e0-df324fe46d30	1	2023-10-16
80425-0358-3	EA - Each	80425-0358	eb8cb3cc-4a39-4ce7-adea-7546438aaf61	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0358	CLONAZEPAM TABLET [ADVANCED RX OF TENNESSEE, LLC]	2	Current NDC, 3 package rows	20250101_04db8e8c-38f9-0c4a-e063-6394a90a93f0.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 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	874b0395-fecb-446a-966f-6ecbb23f1ff6	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	3aa9c3eb-3a0a-4e8b-af68-4f87d87194dd	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	00f323c0-e007-40df-ae7f-e6b3c7ba0aa8	2026-03-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	a4185456-68f9-47d4-9952-fcdef86989db	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	095a80b0-09f9-4bd1-b377-5212d7c966ba	2026-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147
Clonazepam	CLONAZEPAM	PD-Rx Pharmaceuticals, Inc.	9ee4e019-6a99-4aac-84b0-9aae597815a7	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147
Clonazepam	CLONAZEPAM	PD-Rx Pharmaceuticals, Inc.	c707caa1-d6fd-4790-9a64-f749bf93ef18	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147
Clonazepam	CLONAZEPAM	PD-Rx Pharmaceuticals, Inc.	1ce88d2c-70f7-427b-8787-4afd9ce6f71c	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147
Clonazepam	CLONAZEPAM	A-S Medication Solutions	28675dd6-b952-4e71-b0a3-b701ad6b6344	2025-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147
Clonazepam	CLONAZEPAM	St Marys Medical Park Pharmacy	31a7ed52-48a6-1c87-e054-00144ff88e88	2025-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147
Clonazepam	CLONAZEPAM	Advanced Rx of Tennessee, LLC	04db8e8c-38f9-0c4a-e063-6394a90a93f0	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147 ndc (package): 80425-0358-3 ndc (product): 80425-0358 ndc11 (package): 80425035803
Clonazepam	CLONAZEPAM	Advanced Rx Pharmacy of Tennessee, LLC	b9309a1a-a794-2f62-e053-2a95a90a7c34	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147
Clonazepam	CLONAZEPAM	Advanced Rx Pharmacy of Tennessee, LLC	be383e56-d71f-7699-e053-2995a90a50c1	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147
Clonazepam	CLONAZEPAM	NuCare Pharmaceuticals,Inc.	555061d4-276a-4716-e054-00144ff88e88	2024-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	7b0d716c-8f51-47a7-8bf2-07c6f9732a05	2024-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147
Clonazepam	CLONAZEPAM	NuCare Pharmaceuticals,Inc.	a4882077-694d-d46c-e053-2a95a90a217d	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	213c0120-507c-4c39-8aa4-3377f0b06d74	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	4b5240a8-9e87-4664-8698-596a144d6d28	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	9a4d3762-cfeb-4ffb-9c9e-40627cc4df71	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147
Clonazepam	CLONAZEPAM	Accord Healthcare Inc.	ebc11109-e7bf-452d-b675-4b3236d54164	2024-01-04	Boxed warning, 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197527	clonazePAM 0.5 MG Oral Tablet	PSN	04db8e8c-38f9-0c4a-e063-6394a90a93f0	2
197527	clonazepam 0.5 MG Oral Tablet	SCD	04db8e8c-38f9-0c4a-e063-6394a90a93f0	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0358-3	80425035803	90 TABLET in 1 BOTTLE, PLASTIC (80425-0358-3)	90 tablet	2023-09-08	No	No	Current