CLONAZEPAM

Product NDC: 46708-368
11-digit product format: 467080368
Labeler code: 46708
Product ID: 46708-368_e19dd42d-3043-4605-9adf-001741e03942
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CLONAZEPAM
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA211033
Marketing category: ANDA
Marketing start: 2019-07-01
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A211033-001	CLONAZEPAM	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28
A211033-002	CLONAZEPAM	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28
A211033-003	CLONAZEPAM	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28
A211033-004	CLONAZEPAM	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28
A211033-005	CLONAZEPAM	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211033-001	AB
A211033-002	AB
A211033-003	AB
A211033-004	AB
A211033-005	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A211033-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211033-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211033-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211033-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211033-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211033-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211033-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211033-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211033-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211033-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211033-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211033-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211033-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211033-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211033-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211033-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211033-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211033-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211033-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211033-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211033-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211033-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211033-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211033-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211033-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211033-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211033-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211033-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211033-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211033-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211033-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211033-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211033-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211033-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211033-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211033-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211033-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211033-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211033-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211033-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2019-06-28	`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	A211033-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211033-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211033-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211033-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211033-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211033-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211033-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211033-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211033-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211033-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211033-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211033-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211033-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211033-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211033-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211033-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211033-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211033-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211033-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211033-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211033-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211033-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211033-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211033-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211033-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211033-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211033-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211033-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211033-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211033-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211033-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211033-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211033-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211033-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211033-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211033-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211033-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211033-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211033-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211033-005	AB	1	`2680178bc6a6…`

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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349194	Internal RxNorm lookup
349195	Internal RxNorm lookup
349196	Internal RxNorm lookup
349197	Internal RxNorm lookup
349198	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
43ee20ce-0015-413c-b230-822e390b02f7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
f8e2a02d-e7b1-29aa-eb39-98a679441d91	Product name	3	20190927
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
46708-368-06	CLONAZEPAM	6 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	6		2
46708-368-06	CLONAZEPAM	60 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	60		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-368	CLONAZEPAM TABLET, ORALLY DISINTEGRATING [ALEMBIC PHARMACEUTICALS LIMITED]	2	Current NDC, Legacy NDC, 2 package rows	20230129_43ee20ce-0015-413c-b230-822e390b02f7.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ecb28fcb-f0d1-4558-b460-ecabd0f6009e	2025-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211033 application number: ANDA211033
CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Limited	43ee20ce-0015-413c-b230-822e390b02f7	2023-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211033 application number: ANDA211033 ndc (product): 46708-368

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
349194	clonazePAM 0.125 MG Disintegrating Oral Tablet	PSN	43ee20ce-0015-413c-b230-822e390b02f7	2
349195	clonazePAM 0.25 MG Disintegrating Oral Tablet	PSN	43ee20ce-0015-413c-b230-822e390b02f7	2
349198	clonazePAM 0.5 MG Disintegrating Oral Tablet	PSN	43ee20ce-0015-413c-b230-822e390b02f7	2
349196	clonazePAM 1 MG Disintegrating Oral Tablet	PSN	43ee20ce-0015-413c-b230-822e390b02f7	2
349197	clonazePAM 2 MG Disintegrating Oral Tablet	PSN	43ee20ce-0015-413c-b230-822e390b02f7	2
349194	clonazepam 0.125 MG Disintegrating Oral Tablet	SCD	43ee20ce-0015-413c-b230-822e390b02f7	2
349195	clonazepam 0.25 MG Disintegrating Oral Tablet	SCD	43ee20ce-0015-413c-b230-822e390b02f7	2
349198	clonazepam 0.5 MG Disintegrating Oral Tablet	SCD	43ee20ce-0015-413c-b230-822e390b02f7	2
349196	clonazepam 1 MG Disintegrating Oral Tablet	SCD	43ee20ce-0015-413c-b230-822e390b02f7	2
349197	clonazepam 2 MG Disintegrating Oral Tablet	SCD	43ee20ce-0015-413c-b230-822e390b02f7	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
46708-368-06	46708036806	60 BLISTER PACK in 1 CARTON (46708-368-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	60 blister pack	2019-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonazepam Orally Disintegrating Tablets, USP	Alembic Pharmaceuticals Limited	2023-01-27	Human Prescription Drug Label	2