Clobazam

Product NDC: 51672-4203
Requested package NDC: 51672-4203-1
11-digit product format: 516724203
Labeler code: 51672
Product ID: 51672-4203_9e675959-c479-406e-a6f7-dd330f166f6b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clobazam
Dosage form: TABLET
Route: ORAL
Labeler: Taro Pharmaceuticals U.S.A., Inc.
Application: ANDA209440
Marketing category: ANDA
Marketing start: 2018-10-22
Substance: CLOBAZAM
Active strength: 20 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51672-4203	51672-4203-1	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209440-001	CLOBAZAM	CLOBAZAM	10MG	TABLET / ORAL			2018-10-22
A209440-002	CLOBAZAM	CLOBAZAM	20MG	TABLET / ORAL			2018-10-22

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209440-001	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209440-002	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A209440-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209440-002	AB	1	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
713032fb-f461-4501-be8a-ca575cddec45	Product name	7	20211028
f324c243-b420-476a-968a-bb1445dcc148	Product name	1	20190211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51672-4203-1	Clobazam	100 in 1 BOTTLE	TABLET	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-4203-1	EA - Each	51672-4203	a4375d49-71e4-4b1e-9c0e-ad3e522a6db5	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-4203	CLOBAZAM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	3	Current NDC, Legacy NDC, 1 package rows	20181024_c326d915-5cbb-4f96-ba5d-c2b298e10c5d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2MRO291B4U	CLOBAZAM	22316-47-8	CLOBAZAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199450	cloBAZam 10 MG Oral Tablet	PSN	c326d915-5cbb-4f96-ba5d-c2b298e10c5d	3
246172	cloBAZam 20 MG Oral Tablet	PSN	c326d915-5cbb-4f96-ba5d-c2b298e10c5d	3
199450	clobazam 10 MG Oral Tablet	SCD	c326d915-5cbb-4f96-ba5d-c2b298e10c5d	3
246172	clobazam 20 MG Oral Tablet	SCD	c326d915-5cbb-4f96-ba5d-c2b298e10c5d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-4203-1	51672420301	100 TABLET in 1 BOTTLE (51672-4203-1)	100 tablet	2018-10-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clobazam	Taro Pharmaceuticals U.S.A., Inc. \| Taro Pharmaceutical Industries, Ltd.	2018-10-19	HUMAN PRESCRIPTION DRUG LABEL	3