Clonazepam

Product NDC: 67544-529
11-digit product format: 675440529
Labeler code: 67544
Product ID: 67544-529_2458678c-6ce9-4fa4-976a-2c49b489a834
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonazepam
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA074569
Marketing category: ANDA
Marketing start: 1996-09-18
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 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…`

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
6be64dc3-3748-477c-8800-2c2175309c73	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
67544-529-10	Clonazepam	10 in 1 BOTTLE	TABLET	10	2
67544-529-15	Clonazepam	15 in 1 BOTTLE	TABLET	15	2
67544-529-28	Clonazepam	28 in 1 BOTTLE	TABLET	28	2
67544-529-30	Clonazepam	30 in 1 BOTTLE	TABLET	30	2
67544-529-45	Clonazepam	45 in 1 BOTTLE	TABLET	45	2
67544-529-53	Clonazepam	60 in 1 BOTTLE	TABLET	60	2
67544-529-54	Clonazepam	84 in 1 BOTTLE	TABLET	84	2
67544-529-55	Clonazepam	75 in 1 BOTTLE	TABLET	75	2
67544-529-60	Clonazepam	90 in 1 BOTTLE	TABLET	90	2
67544-529-70	Clonazepam	120 in 1 BOTTLE	TABLET	120	2
67544-529-75	Clonazepam	150 in 1 BOTTLE	TABLET	150	2
67544-529-80	Clonazepam	180 in 1 BOTTLE	TABLET	180	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67544-529-10	EA - Each	67544-529	bf4022c6-3e04-46ed-9b31-153308c19fc1	1	2023-09-05
67544-529-15	EA - Each	67544-529	512fbe4b-5ffc-4f4b-a90c-7e4768cb672a	1	2018-05-09
67544-529-28	EA - Each	67544-529	9e4ecd3a-ea27-467d-8d76-99c01770c274	1	2023-09-05
67544-529-54	EA - Each	67544-529	8e7ab722-49cf-406a-acc1-0c6afc61a7a8	1	2023-09-05
67544-529-55	EA - Each	67544-529	bb0b5ae8-6dc6-4e3d-8e01-d0b7af657aeb	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67544-529	CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Current NDC, Legacy NDC, 12 package rows	20230718_6be64dc3-3748-477c-8800-2c2175309c73.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 ndc (product): 67544-529
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197527	clonazePAM 0.5 MG Oral Tablet	PSN	6be64dc3-3748-477c-8800-2c2175309c73	2
197527	clonazepam 0.5 MG Oral Tablet	SCD	6be64dc3-3748-477c-8800-2c2175309c73	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67544-529-10	67544052910	10 TABLET in 1 BOTTLE (67544-529-10)	10 tablet	2023-07-14		No	No	Current
67544-529-15	67544052915	15 TABLET in 1 BOTTLE (67544-529-15)	15 tablet	2018-03-06	0000-00-00	No	No	Current
67544-529-28	67544052928	28 TABLET in 1 BOTTLE (67544-529-28)	28 tablet	2023-07-14		No	No	Current
67544-529-30	67544052930	30 TABLET in 1 BOTTLE (67544-529-30)	30 tablet	2018-03-06	0000-00-00	No	No	Current
67544-529-45	67544052945	45 TABLET in 1 BOTTLE (67544-529-45)	45 tablet	2018-03-06	0000-00-00	No	No	Current
67544-529-53	67544052953	60 TABLET in 1 BOTTLE (67544-529-53)	60 tablet	2018-03-06	0000-00-00	No	No	Current
67544-529-54	67544052954	84 TABLET in 1 BOTTLE (67544-529-54)	84 tablet	2023-07-14		No	No	Current
67544-529-55	67544052955	75 TABLET in 1 BOTTLE (67544-529-55)	75 tablet	2023-07-14		No	No	Current
67544-529-60	67544052960	90 TABLET in 1 BOTTLE (67544-529-60)	90 tablet	2018-03-06	0000-00-00	No	No	Current
67544-529-70	67544052970	120 TABLET in 1 BOTTLE (67544-529-70)	120 tablet	2018-03-06	0000-00-00	No	No	Current
67544-529-75	67544052975	150 TABLET in 1 BOTTLE (67544-529-75)	150 tablet	2018-03-06	0000-00-00	No	No	Current
67544-529-80	67544052980	180 TABLET in 1 BOTTLE (67544-529-80)	180 tablet	2018-03-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonazepam Tablets, USP CIV Rx only	Aphena Pharma Solutions - Tennessee, LLC	2023-07-17	HUMAN PRESCRIPTION DRUG LABEL	2