Klonopin

Product NDC: 61269-610
11-digit product format: 612690610
Labeler code: 61269
Product ID: 61269-610_63cfdab9-fb3d-4c2b-bf88-8ba841dba839
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonazepam
Dosage form: TABLET
Route: ORAL
Labeler: H2-Pharma, LLC
Application: NDA017533
Marketing category: NDA
Marketing start: 1975-06-02
Substance: CLONAZEPAM
Active strength: 1 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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017533-001	KLONOPIN	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982
N017533-002	KLONOPIN	CLONAZEPAM	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
N017533-003	KLONOPIN	CLONAZEPAM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982
N017533-005	KLONOPIN	CLONAZEPAM	0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL			1997-04-09
N017533-006	KLONOPIN	CLONAZEPAM	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL			1997-04-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017533-001	AB
N017533-002	AB
N017533-003	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 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	N017533-001	KLONOPIN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017533-002	KLONOPIN	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017533-003	KLONOPIN	2MG	TABLET / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017533-005	KLONOPIN	0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL			1997-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017533-006	KLONOPIN	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL			1997-04-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017533-001	KLONOPIN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017533-002	KLONOPIN	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017533-003	KLONOPIN	2MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017533-005	KLONOPIN	0.125MG	TABLET / ORAL			1997-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017533-006	KLONOPIN	0.25MG	TABLET / ORAL			1997-04-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017533-001	KLONOPIN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017533-002	KLONOPIN	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017533-003	KLONOPIN	2MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017533-005	KLONOPIN	0.125MG	TABLET / ORAL			1997-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017533-006	KLONOPIN	0.25MG	TABLET / ORAL			1997-04-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017533-001	KLONOPIN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017533-002	KLONOPIN	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017533-003	KLONOPIN	2MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017533-005	KLONOPIN	0.125MG	TABLET / ORAL			1997-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017533-006	KLONOPIN	0.25MG	TABLET / ORAL			1997-04-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017533-001	KLONOPIN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017533-002	KLONOPIN	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017533-003	KLONOPIN	2MG	TABLET / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017533-005	KLONOPIN	0.125MG	TABLET / ORAL			1997-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017533-006	KLONOPIN	0.25MG	TABLET / ORAL			1997-04-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017533-001	KLONOPIN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017533-002	KLONOPIN	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017533-003	KLONOPIN	2MG	TABLET / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017533-005	KLONOPIN	0.125MG	TABLET / ORAL			1997-04-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017533-006	KLONOPIN	0.25MG	TABLET / ORAL			1997-04-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017533-001	KLONOPIN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017533-002	KLONOPIN	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017533-003	KLONOPIN	2MG	TABLET / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017533-005	KLONOPIN	0.125MG	TABLET / ORAL			1997-04-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017533-006	KLONOPIN	0.25MG	TABLET / ORAL			1997-04-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017533-001	KLONOPIN	0.5MG	TABLET / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017533-002	KLONOPIN	1MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017533-003	KLONOPIN	2MG	TABLET / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017533-005	KLONOPIN	0.125MG	TABLET / ORAL			1997-04-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017533-006	KLONOPIN	0.25MG	TABLET / ORAL			1997-04-09	`2680178bc6a6…`

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	N017533-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017533-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017533-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017533-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017533-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017533-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017533-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017533-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017533-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017533-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017533-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017533-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017533-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017533-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017533-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017533-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017533-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017533-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017533-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017533-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017533-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017533-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017533-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017533-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017533-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017533-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017533-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017533-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017533-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017533-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017533-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017533-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017533-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017533-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017533-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017533-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017533-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017533-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017533-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017533-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Klonopin
Listing expiration: 2026-12-31

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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197527	Internal RxNorm lookup
197528	Internal RxNorm lookup
197529	Internal RxNorm lookup
206157	Internal RxNorm lookup
206159	Internal RxNorm lookup
206160	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
cfa0d79a-843c-4b88-95a1-e9511d649ca1	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
61269-610-10	Klonopin	100 in 1 BOTTLE, PLASTIC	TABLET	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61269-610-10	EA - Each	61269-610	22d3ba6d-eb6f-4c23-b2e4-5ccd98577b2b	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61269-610	KLONOPIN (CLONAZEPAM) TABLET [H2-PHARMA, LLC]	5	Current NDC, Legacy NDC, 1 package rows	20241205_cfa0d79a-843c-4b88-95a1-e9511d649ca1.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
Klonopin	CLONAZEPAM	H2-Pharma, LLC	cfa0d79a-843c-4b88-95a1-e9511d649ca1	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017533 application number: NDA017533 ndc (product): 61269-610

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	cfa0d79a-843c-4b88-95a1-e9511d649ca1	6
197528	clonazePAM 1 MG Oral Tablet	PSN	cfa0d79a-843c-4b88-95a1-e9511d649ca1	6
197529	clonazePAM 2 MG Oral Tablet	PSN	cfa0d79a-843c-4b88-95a1-e9511d649ca1	6
206157	KlonoPIN 0.5 MG Oral Tablet	PSN	cfa0d79a-843c-4b88-95a1-e9511d649ca1	6
206159	KlonoPIN 1 MG Oral Tablet	PSN	cfa0d79a-843c-4b88-95a1-e9511d649ca1	6
206160	KlonoPIN 2 MG Oral Tablet	PSN	cfa0d79a-843c-4b88-95a1-e9511d649ca1	6
206157	clonazepam 0.5 MG Oral Tablet [Klonopin]	SBD	cfa0d79a-843c-4b88-95a1-e9511d649ca1	6
206159	clonazepam 1 MG Oral Tablet [Klonopin]	SBD	cfa0d79a-843c-4b88-95a1-e9511d649ca1	6
206160	clonazepam 2 MG Oral Tablet [Klonopin]	SBD	cfa0d79a-843c-4b88-95a1-e9511d649ca1	6
197527	clonazepam 0.5 MG Oral Tablet	SCD	cfa0d79a-843c-4b88-95a1-e9511d649ca1	6
197528	clonazepam 1 MG Oral Tablet	SCD	cfa0d79a-843c-4b88-95a1-e9511d649ca1	6
197529	clonazepam 2 MG Oral Tablet	SCD	cfa0d79a-843c-4b88-95a1-e9511d649ca1	6
206157	Klonopin 0.5 MG Oral Tablet	SY	cfa0d79a-843c-4b88-95a1-e9511d649ca1	6
206159	Klonopin 1 MG Oral Tablet	SY	cfa0d79a-843c-4b88-95a1-e9511d649ca1	6
206160	Klonopin 2 MG Oral Tablet	SY	cfa0d79a-843c-4b88-95a1-e9511d649ca1	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61269-610-10	61269061010	100 TABLET in 1 BOTTLE, PLASTIC (61269-610-10)	100 tablet	2010-09-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
KLONOPIN ® TABLETS (clonazepam)	H2-Pharma, LLC \| CHEPLAPHARM Arzneimittel GmbH	2025-12-01	HUMAN PRESCRIPTION DRUG LABEL	6