Clonazepam

Product NDC: 16729-138
11-digit product format: 167290138
Labeler code: 16729
Product ID: 16729-138_0e1e7f41-f78b-27cf-e063-6394a90a1ae0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clonazepam
Dosage form: TABLET
Route: ORAL
Labeler: Accord Healthcare Inc.
Application: ANDA077147
Marketing category: ANDA
Marketing start: 2011-06-03
Substance: CLONAZEPAM
Active strength: 2 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
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 · 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077147-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077147-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077147-001	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	2 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197527	Internal RxNorm lookup
197528	Internal RxNorm lookup
197529	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
ebc11109-e7bf-452d-b675-4b3236d54164	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	Strength	SPL version
16729-138-00	Clonazepam	100 in 1 BOTTLE, PLASTIC	TABLET	100		9
16729-138-16	Clonazepam	500 in 1 BOTTLE, PLASTIC	TABLET	500		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-138-00	EA - Each	16729-138	1092ec4b-252d-4441-b416-561123b33e13	1	2012-07-24
16729-138-16	EA - Each	16729-138	e81d8cce-f733-4bfb-8c84-407618a377f8	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLONAZEPAM	ACTIVE INGREDIENT	5PE9FDE8GB	CLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]	2
CLONAZEPAM	ACTIVE MOIETY	5PE9FDE8GB	CLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	CLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-138	CLONAZEPAM TABLET [ACCORD HEALTHCARE INC.]	9	Current NDC, Legacy NDC, 2 package rows	20240105_ebc11109-e7bf-452d-b675-4b3236d54164.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
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 ndc (product): 16729-138

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
197529	clonazePAM 2 MG Oral Tablet	PSN	9a4d3762-cfeb-4ffb-9c9e-40627cc4df71	102
197529	clonazepam 2 MG Oral Tablet	SCD	9a4d3762-cfeb-4ffb-9c9e-40627cc4df71	102
197527	clonazePAM 0.5 MG Oral Tablet	PSN	28675dd6-b952-4e71-b0a3-b701ad6b6344	27
197528	clonazePAM 1 MG Oral Tablet	PSN	28675dd6-b952-4e71-b0a3-b701ad6b6344	27
197529	clonazePAM 2 MG Oral Tablet	PSN	28675dd6-b952-4e71-b0a3-b701ad6b6344	27
197527	clonazepam 0.5 MG Oral Tablet	SCD	28675dd6-b952-4e71-b0a3-b701ad6b6344	27
197528	clonazepam 1 MG Oral Tablet	SCD	28675dd6-b952-4e71-b0a3-b701ad6b6344	27
197529	clonazepam 2 MG Oral Tablet	SCD	28675dd6-b952-4e71-b0a3-b701ad6b6344	27
197529	clonazePAM 2 MG Oral Tablet	PSN	1ce88d2c-70f7-427b-8787-4afd9ce6f71c	15
197529	clonazepam 2 MG Oral Tablet	SCD	1ce88d2c-70f7-427b-8787-4afd9ce6f71c	15
197529	clonazePAM 2 MG Oral Tablet	PSN	095a80b0-09f9-4bd1-b377-5212d7c966ba	10
197529	clonazepam 2 MG Oral Tablet	SCD	095a80b0-09f9-4bd1-b377-5212d7c966ba	10
197527	clonazePAM 0.5 MG Oral Tablet	PSN	ebc11109-e7bf-452d-b675-4b3236d54164	9
197528	clonazePAM 1 MG Oral Tablet	PSN	ebc11109-e7bf-452d-b675-4b3236d54164	9
197529	clonazePAM 2 MG Oral Tablet	PSN	ebc11109-e7bf-452d-b675-4b3236d54164	9
197527	clonazepam 0.5 MG Oral Tablet	SCD	ebc11109-e7bf-452d-b675-4b3236d54164	9
197528	clonazepam 1 MG Oral Tablet	SCD	ebc11109-e7bf-452d-b675-4b3236d54164	9
197529	clonazepam 2 MG Oral Tablet	SCD	ebc11109-e7bf-452d-b675-4b3236d54164	9
197529	clonazePAM 2 MG Oral Tablet	PSN	ea4a77d6-d5f2-4e28-a156-5af5b3fbac07	3
197529	clonazepam 2 MG Oral Tablet	SCD	ea4a77d6-d5f2-4e28-a156-5af5b3fbac07	3
197528	clonazePAM 1 MG Oral Tablet	PSN	3ca76628-96c5-4fda-a4ee-eeafbcf90a07	2
197529	clonazePAM 2 MG Oral Tablet	PSN	3ca76628-96c5-4fda-a4ee-eeafbcf90a07	2
197529	clonazePAM 2 MG Oral Tablet	PSN	b5f7cfb2-2988-5f00-e053-2a95a90aae6d	2
197528	clonazepam 1 MG Oral Tablet	SCD	3ca76628-96c5-4fda-a4ee-eeafbcf90a07	2
197529	clonazepam 2 MG Oral Tablet	SCD	b5f7cfb2-2988-5f00-e053-2a95a90aae6d	2
197529	clonazepam 2 MG Oral Tablet	SCD	3ca76628-96c5-4fda-a4ee-eeafbcf90a07	2
197527	clonazePAM 0.5 MG Oral Tablet	PSN	58af8964-3480-2139-e053-2991aa0a0624	1
197528	clonazePAM 1 MG Oral Tablet	PSN	58af8964-3480-2139-e053-2991aa0a0624	1
197529	clonazePAM 2 MG Oral Tablet	PSN	ea0e79ce-74a1-436c-bac8-f2b80201b587	1
197529	clonazePAM 2 MG Oral Tablet	PSN	58af8964-3480-2139-e053-2991aa0a0624	1
197527	clonazepam 0.5 MG Oral Tablet	SCD	58af8964-3480-2139-e053-2991aa0a0624	1
197528	clonazepam 1 MG Oral Tablet	SCD	58af8964-3480-2139-e053-2991aa0a0624	1
197529	clonazepam 2 MG Oral Tablet	SCD	ea0e79ce-74a1-436c-bac8-f2b80201b587	1
197529	clonazepam 2 MG Oral Tablet	SCD	58af8964-3480-2139-e053-2991aa0a0624	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-138-00	16729013800	100 TABLET in 1 BOTTLE, PLASTIC (16729-138-00)	100 tablet	2011-06-03	0000-00-00	No	No	Current
16729-138-16	16729013816	500 TABLET in 1 BOTTLE, PLASTIC (16729-138-16)	500 tablet	2011-06-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonazepam Tablets, USP Rx only	REMEDYREPACK INC.	2026-02-03	HUMAN PRESCRIPTION DRUG LABEL	10
Clonazepam Tablets, USP Rx only	PD-Rx Pharmaceuticals, Inc.	2025-10-16	HUMAN PRESCRIPTION DRUG LABEL	15
Clonazepam Tablets, USP Rx only	A-S Medication Solutions	2025-06-09	HUMAN PRESCRIPTION DRUG LABEL	27
Clonazepam Tablets, USP Rx only	REMEDYREPACK INC.	2024-08-09	HUMAN PRESCRIPTION DRUG LABEL	11
Clonazepam Tablets, USP Rx only	Bryant Ranch Prepack	2024-04-05	HUMAN PRESCRIPTION DRUG LABEL	102
Clonazepam Tablets, USP Rx only	Preferred Pharmaceuticals Inc.	2024-03-29	HUMAN PRESCRIPTION DRUG LABEL	7
Clonazepam Tablets, USP Rx only	Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	2024-01-04	HUMAN PRESCRIPTION DRUG LABEL	9
Clonazepam Tablets, USP CIV Rx only	NuCare Pharmaceuticals,Inc.	2022-01-14	HUMAN PRESCRIPTION DRUG LABEL	2
Clonazepam Tablets, USP CIV Rx only	A-S Medication Solutions	2021-06-14	HUMAN PRESCRIPTION DRUG LABEL	3
Clonazepam Tablets, USP CIV Rx only	NuCare Pharmaceuticals,Inc.	2021-02-22	HUMAN PRESCRIPTION DRUG LABEL	2
Clonazepam Tablets, USP CIV Rx only	ATLANTIC BIOLOGICALS CORP.	2021-01-20	HUMAN PRESCRIPTION DRUG LABEL	2
Clonazepam Tablets, USP CIV Rx only	NuCare Pharmaceuticals, Inc.	2020-01-21	HUMAN PRESCRIPTION DRUG LABEL	2
Clonazepam Tablets, USP CIV Rx only	Aphena Pharma Solutions - Tennessee, LLC	2019-02-19	HUMAN PRESCRIPTION DRUG LABEL	1
Clonazepam Tablets, USP CIV Rx only	NCS HealthCare of KY, LLC dba Vangard Labs	2018-12-10	HUMAN PRESCRIPTION DRUG LABEL	2
Clonazepam Tablets, USP 918 921 922 CIV Rx only	Contract Pharmacy Services-PA \| Coupler Enterprises	2017-09-08	HUMAN PRESCRIPTION DRUG LABEL	1