SYMPAZAN

Product NDC: 10094-205
11-digit product format: 100940205
Labeler code: 10094
Product ID: 10094-205_4a004ed9-140a-4054-843c-4e31d42667ec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clobazam
Dosage form: FILM
Route: ORAL
Labeler: Aquestive Therapeutics
Application: NDA210833
Marketing category: NDA
Marketing start: 2018-11-01
Substance: CLOBAZAM
Active strength: 5 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

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	RLD / RS	Approval date
N210833-001	SYMPAZAN	CLOBAZAM	5MG	FILM / ORAL	RLD	2018-11-01
N210833-002	SYMPAZAN	CLOBAZAM	10MG	FILM / ORAL	RLD	2018-11-01
N210833-003	SYMPAZAN	CLOBAZAM	20MG	FILM / ORAL	RLD, RS	2018-11-01

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210833-001	12290597	2039-09-05	U-724	Drug product	2025-11-12
N210833-001	12403090	2039-09-05	U-724	Drug product	2025-11-12
N210833-001	11541002	2040-01-31	U-724	Drug product	2023-01-04
N210833-002	12290597	2039-09-05	U-724	Drug product	2025-11-12
N210833-002	12403090	2039-09-05	U-724	Drug product	2025-11-12
N210833-002	11541002	2040-01-31	U-724	Drug product	2023-01-04
N210833-003	11541002	2040-01-31	U-724	Drug product	2023-01-04

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210833-001	SYMPAZAN	5MG	FILM / ORAL	RLD	2018-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210833-002	SYMPAZAN	10MG	FILM / ORAL	RLD	2018-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210833-003	SYMPAZAN	20MG	FILM / ORAL	RLD, RS	2018-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210833-001	SYMPAZAN	5MG	FILM / ORAL	RLD	2018-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210833-002	SYMPAZAN	10MG	FILM / ORAL	RLD	2018-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210833-003	SYMPAZAN	20MG	FILM / ORAL	RLD, RS	2018-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210833-001	SYMPAZAN	5MG	FILM / ORAL	RLD	2018-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210833-002	SYMPAZAN	10MG	FILM / ORAL	RLD	2018-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210833-003	SYMPAZAN	20MG	FILM / ORAL	RLD, RS	2018-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210833-001	SYMPAZAN	5MG	FILM / ORAL	RLD	2018-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210833-002	SYMPAZAN	10MG	FILM / ORAL	RLD	2018-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210833-003	SYMPAZAN	20MG	FILM / ORAL	RLD, RS	2018-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210833-001	SYMPAZAN	5MG	FILM / ORAL	RLD	2018-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210833-002	SYMPAZAN	10MG	FILM / ORAL	RLD	2018-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210833-003	SYMPAZAN	20MG	FILM / ORAL	RLD, RS	2018-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210833-001	SYMPAZAN	5MG	FILM / ORAL	RLD	2018-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210833-002	SYMPAZAN	10MG	FILM / ORAL	RLD	2018-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210833-003	SYMPAZAN	20MG	FILM / ORAL	RLD, RS	2018-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210833-001	SYMPAZAN	5MG	FILM / ORAL	RLD	2018-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210833-002	SYMPAZAN	10MG	FILM / ORAL	RLD	2018-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210833-003	SYMPAZAN	20MG	FILM / ORAL	RLD, RS	2018-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210833-001	SYMPAZAN	5MG	FILM / ORAL	RLD	2018-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210833-002	SYMPAZAN	10MG	FILM / ORAL	RLD	2018-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210833-003	SYMPAZAN	20MG	FILM / ORAL	RLD, RS	2018-11-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210833-001	SYMPAZAN	5MG	FILM / ORAL	RLD	2018-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210833-002	SYMPAZAN	10MG	FILM / ORAL	RLD	2018-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210833-003	SYMPAZAN	20MG	FILM / ORAL	RLD, RS	2018-11-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210833-001	SYMPAZAN	5MG	FILM / ORAL	RLD	2018-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210833-002	SYMPAZAN	10MG	FILM / ORAL	RLD	2018-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210833-003	SYMPAZAN	20MG	FILM / ORAL	RLD, RS	2018-11-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210833-001	SYMPAZAN	5MG	FILM / ORAL	RLD	2018-11-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210833-002	SYMPAZAN	10MG	FILM / ORAL	RLD	2018-11-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210833-003	SYMPAZAN	20MG	FILM / ORAL	RLD, RS	2018-11-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210833-001	SYMPAZAN	5MG	FILM / ORAL	RLD	2018-11-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210833-002	SYMPAZAN	10MG	FILM / ORAL	RLD	2018-11-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210833-003	SYMPAZAN	20MG	FILM / ORAL	RLD, RS	2018-11-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210833-001	SYMPAZAN	5MG	FILM / ORAL	RLD	2018-11-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210833-002	SYMPAZAN	10MG	FILM / ORAL	RLD	2018-11-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210833-003	SYMPAZAN	20MG	FILM / ORAL	RLD, RS	2018-11-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210833-001	SYMPAZAN	5MG	FILM / ORAL	RLD	2018-11-01	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 294 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210833-001	12290597	2039-09-05	U-724	Drug product	2025-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210833-001	12403090	2039-09-05	U-724	Drug product	2025-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210833-001	11541002	2040-01-31	U-724	Drug product	2023-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210833-002	12290597	2039-09-05	U-724	Drug product	2025-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210833-002	12403090	2039-09-05	U-724	Drug product	2025-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210833-002	11541002	2040-01-31	U-724	Drug product	2023-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210833-003	11541002	2040-01-31	U-724	Drug product	2023-01-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210833-001	12290597	2039-09-05	U-724	Drug product	2025-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210833-001	12403090	2039-09-05	U-724	Drug product	2025-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210833-001	11541002	2040-01-31	U-724	Drug product	2023-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210833-002	12290597	2039-09-05	U-724	Drug product	2025-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210833-002	12403090	2039-09-05	U-724	Drug product	2025-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210833-002	11541002	2040-01-31	U-724	Drug product	2023-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210833-003	11541002	2040-01-31	U-724	Drug product	2023-01-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210833-001	11541002	2040-01-31	U-724	Drug product	2023-01-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210833-002	11541002	2040-01-31	U-724	Drug product	2023-01-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210833-003	11541002	2040-01-31	U-724	Drug product	2023-01-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210833-001	11541002	2040-01-31	U-724	Drug product	2023-01-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210833-002	11541002	2040-01-31	U-724	Drug product	2023-01-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210833-003	11541002	2040-01-31	U-724	Drug product	2023-01-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210833-001	11541002	2040-01-31	U-724	Drug product	2023-01-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210833-002	11541002	2040-01-31	U-724	Drug product	2023-01-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210833-003	11541002	2040-01-31	U-724	Drug product	2023-01-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210833-001	8765167	2024-02-20		Drug product	2018-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210833-001	8603514	2024-04-03		Drug product	2018-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210833-001	11541002	2040-01-31	U-724	Drug product	2023-01-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210833-002	8765167	2024-02-20		Drug product	2018-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210833-002	8603514	2024-04-03		Drug product	2018-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210833-002	11541002	2040-01-31	U-724	Drug product	2023-01-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210833-003	8765167	2024-02-20		Drug product	2018-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210833-003	8603514	2024-04-03		Drug product	2018-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210833-003	11541002	2040-01-31	U-724	Drug product	2023-01-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210833-001	8765167	2024-02-20		Drug product	2018-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210833-001	8603514	2024-04-03		Drug product	2018-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210833-001	11541002	2040-01-31	U-724	Drug product	2023-01-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210833-002	8765167	2024-02-20		Drug product	2018-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210833-002	8603514	2024-04-03		Drug product	2018-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210833-002	11541002	2040-01-31	U-724	Drug product	2023-01-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210833-003	8765167	2024-02-20		Drug product	2018-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210833-003	8603514	2024-04-03		Drug product	2018-11-30	`2680178bc6a6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOBAZAM	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2MRO291B4U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2058253	Internal RxNorm lookup
2058254	Internal RxNorm lookup
2058255	Internal RxNorm lookup
2102713	Internal RxNorm lookup
2102715	Internal RxNorm lookup
2102717	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
5e3d8fcb-aa7d-4822-88fc-4f06264c3242	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
713032fb-f461-4501-be8a-ca575cddec45	Product name	7	20211028
f324c243-b420-476a-968a-bb1445dcc148	Product name	1	20190211
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10094-205-01	SYMPAZAN	1 in 1 POUCH	FILM	1		14
10094-205-60	SYMPAZAN	60 in 1 PACKAGE	FILM	60		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10094-205-01	EA - Each	10094-205	21016fc5-e7f0-4d14-97de-f5a0c441c34f	1	2018-12-13
10094-205-60	EA - Each	10094-205	12fe0b5c-1535-4922-8724-ec3f4f77dd44	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10094-205	SYMPAZAN (CLOBAZAM) FILM [AQUESTIVE THERAPEUTICS]	12	Current NDC, Legacy NDC, 2 package rows	20240316_5e3d8fcb-aa7d-4822-88fc-4f06264c3242.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
SYMPAZAN	CLOBAZAM	Aquestive Therapeutics	5e3d8fcb-aa7d-4822-88fc-4f06264c3242	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 210833 application number: NDA210833 ndc (product): 10094-205

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
2058253	cloBAZam 10 MG Oral Film	PSN	5e3d8fcb-aa7d-4822-88fc-4f06264c3242	14
2058254	cloBAZam 20 MG Oral Film	PSN	5e3d8fcb-aa7d-4822-88fc-4f06264c3242	14
2058255	cloBAZam 5 MG Oral Film	PSN	5e3d8fcb-aa7d-4822-88fc-4f06264c3242	14
2102713	Sympazan 10 MG Oral Film	PSN	5e3d8fcb-aa7d-4822-88fc-4f06264c3242	14
2102715	Sympazan 20 MG Oral Film	PSN	5e3d8fcb-aa7d-4822-88fc-4f06264c3242	14
2102717	Sympazan 5 MG Oral Film	PSN	5e3d8fcb-aa7d-4822-88fc-4f06264c3242	14
2102713	clobazam 10 MG Oral Film [Sympazan]	SBD	5e3d8fcb-aa7d-4822-88fc-4f06264c3242	14
2102715	clobazam 20 MG Oral Film [Sympazan]	SBD	5e3d8fcb-aa7d-4822-88fc-4f06264c3242	14
2102717	clobazam 5 MG Oral Film [Sympazan]	SBD	5e3d8fcb-aa7d-4822-88fc-4f06264c3242	14
2058253	clobazam 10 MG Oral Film	SCD	5e3d8fcb-aa7d-4822-88fc-4f06264c3242	14
2058254	clobazam 20 MG Oral Film	SCD	5e3d8fcb-aa7d-4822-88fc-4f06264c3242	14
2058255	clobazam 5 MG Oral Film	SCD	5e3d8fcb-aa7d-4822-88fc-4f06264c3242	14
2102713	Sympazan 10 MG Oral Film	SY	5e3d8fcb-aa7d-4822-88fc-4f06264c3242	14
2102715	Sympazan 20 MG Oral Film	SY	5e3d8fcb-aa7d-4822-88fc-4f06264c3242	14
2102717	Sympazan 5 MG Oral Film	SY	5e3d8fcb-aa7d-4822-88fc-4f06264c3242	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10094-205-01	10094020501	1 in 1 POUCH						Historical
10094-205-60	10094020560	60 POUCH in 1 PACKAGE (10094-205-60) / 1 FILM in 1 POUCH (10094-205-01)	60 pouch	2018-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SYMPAZAN - Aquestive Therapeutics	Aquestive Therapeutics	2025-12-01	HUMAN PRESCRIPTION DRUG LABEL	14