Clonazepam

Product NDC: 53002-1306
11-digit product format: 530021306
Labeler code: 53002
Product ID: 53002-1306_52268cc1-9302-44f1-84dd-c31b67c62b61
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonazepam
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA074569
Marketing category: ANDA
Marketing start: 1996-09-18
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: 2019-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53002-1306		I	Inactivated by FDA	2026-08-17
excluded package	package	53002-1306	53002-1306-1	I	Inactivated by FDA	2026-08-17
excluded package	package	53002-1306	53002-1306-2	I	Inactivated by FDA	2026-08-17
excluded package	package	53002-1306	53002-1306-3	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 · 60 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-1306-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-1306-2	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-1306-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-1306-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-1306-2	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-1306-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-1306-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-1306-2	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-1306-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-1306-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-1306-2	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-1306-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-1306-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-1306-2	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-1306-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-1306-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-1306-2	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-1306-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-1306-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-1306-2	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-1306-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-1306-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-1306-2	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-1306-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-1306-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-1306-2	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-1306-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53002-1306-2	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53002-1306-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53002-1306-3	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53002-1306-2	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53002-1306-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53002-1306-3	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53002-1306-2	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53002-1306-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53002-1306-3	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53002-1306-2	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53002-1306-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53002-1306-3	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-1306-2	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-1306-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-1306-3	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-1306-2	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-1306-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-1306-3	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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…`

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, Effective, Related label table
NDC	Effective	Related label
53002-1306-1	2025-01-30	CLONAZEPAM TABLETS USP CIV Rx only
53002-1306-2	2025-01-30	CLONAZEPAM TABLETS USP CIV Rx only
53002-1306-3	2025-01-30	CLONAZEPAM TABLETS USP CIV Rx only
53002-1306-1	2023-07-10	CLONAZEPAM TABLETS USP CIV Rx only
53002-1306-2	2023-07-10	CLONAZEPAM TABLETS USP CIV Rx only
53002-1306-3	2023-07-10	CLONAZEPAM TABLETS USP CIV Rx only
53002-1306-1	2020-01-31	CLONAZEPAM TABLETS USP CIV Rx only
53002-1306-2	2020-01-31	CLONAZEPAM TABLETS USP CIV Rx only
53002-1306-3	2020-01-31	CLONAZEPAM TABLETS USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-1306-1	Clonazepam	10 in 1 BOTTLE	TABLET	10	5
53002-1306-2	Clonazepam	20 in 1 BOTTLE	TABLET	20	5
53002-1306-3	Clonazepam	30 in 1 BOTTLE	TABLET	30	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-1306	CLONAZEPAM TABLET [RPK PHARMACEUTICALS, INC.]	5	Legacy NDC, 3 package rows	20230711_b52f7588-eaf1-4253-95c1-d228d01862ef.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
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	b52f7588-eaf1-4253-95c1-d228d01862ef	5
197527	clonazepam 0.5 MG Oral Tablet	SCD	b52f7588-eaf1-4253-95c1-d228d01862ef	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53002-1306-1	53002130601	10 in 1 BOTTLE	Historical
53002-1306-2	53002130602	20 in 1 BOTTLE	Historical
53002-1306-3	53002130603	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLONAZEPAM TABLETS USP CIV Rx only	RPK Pharmaceuticals, Inc.	2020-12-15	HUMAN PRESCRIPTION DRUG LABEL	5