Clonazepam

Product NDC: 70518-4074
Requested package NDC: 70518-4074-0
11-digit product format: 705184074
Labeler code: 70518
Product ID: 70518-4074_5a07d824-1e54-15e7-e063-6294a90aee24
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonazepam
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA075150
Marketing category: ANDA
Marketing start: 2024-05-10
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

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
A075150-001	CLONAZEPAM	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05
A075150-002	CLONAZEPAM	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05
A075150-003	CLONAZEPAM	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075150-001	AB
A075150-002	AB
A075150-003	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	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 87 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	A075150-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075150-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075150-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075150-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075150-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075150-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075150-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075150-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075150-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075150-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075150-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075150-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075150-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075150-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075150-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075150-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075150-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075150-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075150-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075150-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075150-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075150-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075150-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075150-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075150-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075150-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075150-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075150-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075150-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075150-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075150-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075150-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075150-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075150-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075150-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075150-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075150-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075150-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075150-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075150-001	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
2606ecf9-3d71-4c1c-bfda-d7d98ffc6011	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
70518-4074-0	Clonazepam	30 in 1 BLISTER PACK	TABLET	30	7
70518-4074-1	Clonazepam	100 in 1 BOX	TABLET	100	7
70518-4074-2	Clonazepam	1 in 1 POUCH	TABLET	1	7
70518-4074-3	Clonazepam	30 in 1 BLISTER PACK	TABLET	30	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-4074	CLONAZEPAM TABLET [REMEDYREPACK INC.]	4	Current NDC, 4 package rows	20250522_2606ecf9-3d71-4c1c-bfda-d7d98ffc6011.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.	2606ecf9-3d71-4c1c-bfda-d7d98ffc6011	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150 ndc (package): 70518-4074-0 ndc (product): 70518-4074 ndc11 (package): 70518407400
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	1fb0807c-dccd-47a5-ada4-91418c4f47f5	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	f613573a-3e8b-4abf-af69-0268f3d6f481	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150
Clonazepam	CLONAZEPAM	Proficient Rx LP	44f39aa8-a7bc-4e42-977c-31583e6388ae	2026-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	dec8b5b2-2490-4880-a8d1-707b57954297	2025-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	214e760b-c909-bd93-e063-6294a90ae74a	2024-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	20b3125e-4489-3c53-e063-6294a90a6539	2024-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150
Clonazepam	CLONAZEPAM	Advanced Rx Pharmacy of Tennessee, LLC	04db0fbe-7fa3-28af-e063-6294a90abbe6	2024-06-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150
Clonazepam	CLONAZEPAM	Aurobindo Pharma Limited	b1582eb7-af35-45d5-a52e-0e380d08527d	2023-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150

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	2606ecf9-3d71-4c1c-bfda-d7d98ffc6011	7
197528	clonazepam 1 MG Oral Tablet	SCD	2606ecf9-3d71-4c1c-bfda-d7d98ffc6011	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4074-0	70518407400	30 TABLET in 1 BLISTER PACK (70518-4074-0)	30 tablet	2024-05-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonazepam Tablets, USP CIV 0.5 mg, 1 mg and 2 mg Rx only	REMEDYREPACK INC.	2026-08-27	HUMAN PRESCRIPTION DRUG LABEL	8