Clonazepam

Product NDC: 17856-0133
Requested package NDC: 17856-0133-1
11-digit product format: 178560133
Labeler code: 17856
Product ID: 17856-0133_20fe4975-ff88-4030-b531-fb646af650d6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clonazepam
Dosage form: TABLET
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: ANDA077147
Marketing category: ANDA
Marketing start: 2018-07-18
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: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	17856-0133	17856-0133-1	I	Inactivated by FDA		2026-10-16

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 132 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
2026-10-15 13:18:30	2026-09	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`c2088c7a36db…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A077147-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077147-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077147-003	AB	1	`c2088c7a36db…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17856-0133-1	2022-01-28	C162847	48780-1	9d75b9d0-36d3-f424-e053-dadaa90a57ce	Clonazepam Tablets, USP CIV Rx only
17856-0133-1	2020-03-28	C162847	48780-1	9d75b9d0-36d3-f424-e053-dadaa90a57ce	Clonazepam Tablets, USP CIV Rx only
17856-0133-1	2020-01-31	C162847	48780-1	9d75b9d0-36d3-f424-e053-dadaa90a57ce	Clonazepam Tablets, USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17856-0133-1	Clonazepam	100 in 1 BOX, UNIT-DOSE	TABLET	100		3
17856-0133-1	Clonazepam	1 in 1 POUCH	TABLET	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0133	CLONAZEPAM TABLET [ATLANTIC BIOLOGICALS CORP.]	3	Legacy NDC, 2 package rows	20200330_7f7a5a78-ec40-428c-a922-24166dc74cdb.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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonazepam	CLONAZEPAM	Proficient Rx LP	d65c9a1e-f2f4-46d2-9b28-ba0e5c67e542	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147
Clonazepam	CLONAZEPAM	Proficient Rx LP	4dcb6785-e16b-4692-89b3-f905979ca5ae	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	c68420a9-b646-4a4f-99f7-43d652312eb0	2018-02-14	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	7f7a5a78-ec40-428c-a922-24166dc74cdb	3
197527	clonazepam 0.5 MG Oral Tablet	SCD	7f7a5a78-ec40-428c-a922-24166dc74cdb	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-0133-1	17856013301	100 POUCH in 1 BOX, UNIT-DOSE (17856-0133-1) > 1 TABLET in 1 POUCH	100 pouch	2020-03-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonazepam Tablets, USP CIV Rx only	ATLANTIC BIOLOGICALS CORP.	2020-03-27	HUMAN PRESCRIPTION DRUG LABEL	3