clobazam

Product NDC: 51991-900
11-digit product format: 519910900
Labeler code: 51991
Product ID: 51991-900_b7fdaf63-fecd-4bcc-bd00-efffe7e9becd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CLOBAZAM
Dosage form: TABLET
Route: ORAL
Labeler: Breckenridge Pharmaceutical, Inc.
Application: ANDA209308
Marketing category: ANDA
Marketing start: 2018-10-22
Marketing end: 0000-00-00
Substance: CLOBAZAM
Active strength: 10 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: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51991-900		D	Discontinued by firm		2026-08-07
excluded package	package	51991-900	51991-900-01	D	Discontinued by firm		2026-08-07

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51991-900-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51991-900-01	`f5e01cc5f278…`	`a2eaf40c39c3…`

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

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	Approval date
A209308-001	CLOBAZAM	CLOBAZAM	10MG	TABLET / ORAL	2018-10-22
A209308-002	CLOBAZAM	CLOBAZAM	20MG	TABLET / ORAL	2018-10-22
A209308-003	CLOBAZAM	CLOBAZAM	5MG	TABLET / ORAL	2021-10-19

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 · 115 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
2026-02-19 14:30 UTC	2026-02	A209308-001	CLOBAZAM	10MG	TABLET / ORAL		2018-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209308-002	CLOBAZAM	20MG	TABLET / ORAL		2018-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209308-003	CLOBAZAM	5MG	TABLET / ORAL		2021-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209308-001	CLOBAZAM	10MG	TABLET / ORAL		2018-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209308-002	CLOBAZAM	20MG	TABLET / ORAL		2018-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209308-003	CLOBAZAM	5MG	TABLET / ORAL		2021-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209308-001	CLOBAZAM	10MG	TABLET / ORAL		2018-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209308-002	CLOBAZAM	20MG	TABLET / ORAL		2018-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209308-003	CLOBAZAM	5MG	TABLET / ORAL		2021-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209308-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209308-002	CLOBAZAM	20MG	TABLET / ORAL		2018-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209308-003	CLOBAZAM	5MG	TABLET / ORAL		2021-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209308-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209308-002	CLOBAZAM	20MG	TABLET / ORAL		2018-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209308-003	CLOBAZAM	5MG	TABLET / ORAL		2021-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209308-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209308-002	CLOBAZAM	20MG	TABLET / ORAL		2018-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209308-003	CLOBAZAM	5MG	TABLET / ORAL		2021-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209308-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209308-002	CLOBAZAM	20MG	TABLET / ORAL		2018-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209308-003	CLOBAZAM	5MG	TABLET / ORAL		2021-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209308-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209308-002	CLOBAZAM	20MG	TABLET / ORAL		2018-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209308-003	CLOBAZAM	5MG	TABLET / ORAL		2021-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209308-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209308-002	CLOBAZAM	20MG	TABLET / ORAL		2018-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209308-003	CLOBAZAM	5MG	TABLET / ORAL		2021-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209308-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209308-002	CLOBAZAM	20MG	TABLET / ORAL		2018-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209308-003	CLOBAZAM	5MG	TABLET / ORAL		2021-10-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209308-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209308-002	CLOBAZAM	20MG	TABLET / ORAL		2018-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209308-003	CLOBAZAM	5MG	TABLET / ORAL		2021-10-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209308-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209308-002	CLOBAZAM	20MG	TABLET / ORAL		2018-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209308-003	CLOBAZAM	5MG	TABLET / ORAL		2021-10-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209308-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209308-002	CLOBAZAM	20MG	TABLET / ORAL		2018-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209308-003	CLOBAZAM	5MG	TABLET / ORAL		2021-10-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209308-001	CLOBAZAM	10MG	TABLET / ORAL	AB	2018-10-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 62 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209308-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209308-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209308-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209308-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209308-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209308-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209308-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209308-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209308-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209308-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209308-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209308-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209308-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209308-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209308-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209308-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209308-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209308-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209308-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209308-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209308-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209308-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209308-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209308-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209308-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209308-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209308-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209308-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209308-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209308-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209308-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209308-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209308-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209308-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209308-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209308-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209308-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209308-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209308-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209308-001	AB	1	`1c564ffb4f44…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51991-900-01	EA - Each	51991-900	93f79dba-2035-49f9-a19e-b2e849efab02	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51991-900	CLOBAZAM TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]	14	Legacy NDC	20230306_dd6a7bde-62c5-43e2-81f8-1f7dd63757b3.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51991-900-01	51991090001	100 TABLET in 1 BOTTLE (51991-900-01)	100 tablet	2018-10-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
clobazam	Breckenridge Pharmaceutical, Inc. \| Centaur Pharmaceuticals Private Limited	2023-02-28	HUMAN PRESCRIPTION DRUG LABEL	14