Clonazepam

Product NDC: 50090-7555
11-digit product format: 500907555
Labeler code: 50090
Product ID: 50090-7555_625a86a9-4b19-498f-8907-31c63cd320d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clonazepam
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA077171
Marketing category: ANDA
Marketing start: 2005-08-05
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50090-7555		D	Discontinued by firm		2026-08-17
excluded package	package	50090-7555	50090-7555-0	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077171-001	CLONAZEPAM	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03
A077171-002	CLONAZEPAM	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03
A077171-003	CLONAZEPAM	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03
A077171-004	CLONAZEPAM	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2005-08-03
A077171-005	CLONAZEPAM	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A077171-001	AB
A077171-002	AB
A077171-003	AB
A077171-004	AB
A077171-005	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 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077171-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077171-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077171-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077171-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2005-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077171-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077171-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077171-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077171-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077171-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2005-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077171-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077171-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077171-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077171-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077171-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2005-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077171-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077171-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077171-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077171-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077171-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2005-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077171-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077171-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077171-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077171-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077171-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2005-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077171-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077171-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077171-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077171-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077171-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2005-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077171-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077171-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077171-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077171-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077171-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2005-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077171-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077171-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077171-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077171-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077171-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2005-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077171-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2005-08-03	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 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	A077171-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077171-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077171-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077171-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077171-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077171-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077171-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077171-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077171-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077171-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077171-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077171-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077171-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077171-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077171-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077171-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077171-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077171-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077171-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077171-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077171-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077171-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077171-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077171-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077171-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077171-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077171-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077171-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077171-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077171-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077171-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077171-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077171-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077171-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077171-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077171-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077171-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077171-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077171-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077171-005	AB	1	`2680178bc6a6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
f8e2a02d-e7b1-29aa-eb39-98a679441d91	Product name	3	20190927
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
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
50090-7555-0	Clonazepam	60 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-7555-0	EA - Each	50090-7555	8b9af605-ef1d-4f61-b19a-ed3d286dbfde	1	2025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-7555	CLONAZEPAM TABLET, ORALLY DISINTEGRATING [A-S MEDICATION SOLUTIONS]	1	Current NDC, 1 package rows	20250529_08b9b8b4-d1b3-4050-8c1b-811fab8d4e1a.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonazepam	CLONAZEPAM	Par Health USA, LLC	1aef0069-80ea-483d-ac70-c8d485462c5b	2025-10-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077171 application number: ANDA077171

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
349198	clonazePAM 0.5 MG Disintegrating Oral Tablet	PSN	08b9b8b4-d1b3-4050-8c1b-811fab8d4e1a	1
349198	clonazepam 0.5 MG Disintegrating Oral Tablet	SCD	08b9b8b4-d1b3-4050-8c1b-811fab8d4e1a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50090-7555-0	50090755500	60 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (50090-7555-0)	2025-05-27	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonazepam Orally Disintegrating Tablets, USP Rx only	A-S Medication Solutions	2025-05-28	HUMAN PRESCRIPTION DRUG LABEL	1