Clobazam

Product NDC
31722-641
11-digit product format
317220641
Labeler code
31722
Product ID
31722-641_f4e0965c-10a9-5b3c-e053-2995a90a4a5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobazam
Dosage form
SUSPENSION
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA209796
Marketing category
ANDA
Marketing start
2020-02-24
Substance
CLOBAZAM
Active strength
2.5 mg/mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209796-001CLOBAZAMCLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209796-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-244b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-24c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-24cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209796-001CLOBAZAM2.5MG/MLSUSPENSION / ORALAB2020-02-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209796-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209796-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209796-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209796-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209796-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209796-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209796-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209796-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209796-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209796-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209796-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209796-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209796-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209796-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209796-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209796-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209796-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A209796-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209796-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209796-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A209796-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209796-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209796-001AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209796-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209796-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209796-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209796-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209796-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209796-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209796-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209796-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209796-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209796-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209796-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209796-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209796-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209796-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Clobazam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOBAZAM2.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2MRO291B4UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1366192Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c9b51794-3cfa-4a34-b5bb-d523b5798c17Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
713032fb-f461-4501-be8a-ca575cddec45Product name720211028
f324c243-b420-476a-968a-bb1445dcc148Product name120190211
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-641-12Clobazam120 mL in 1 BOTTLE, GLASSSUSPENSION1203
31722-641-12Clobazam1 in 1 CARTONSUSPENSION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-641CLOBAZAM (CLOBAZAM) SUSPENSION [CAMBER PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20230219_c9b51794-3cfa-4a34-b5bb-d523b5798c17.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClobazamCLOBAZAMCamber Pharmaceuticals, Inc.c9b51794-3cfa-4a34-b5bb-d523b5798c172026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209796
application number: ANDA209796
ndc (product): 31722-641
ClobazamCLOBAZAMNorthStar RxLLC574a3f91-d73e-46bc-b4a1-2388439521fb2023-03-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209796
application number: ANDA209796

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366192cloBAZam 2.5 MG in 1 mL Oral SuspensionPSNc9b51794-3cfa-4a34-b5bb-d523b5798c173
1366192clobazam 2.5 MG/ML Oral SuspensionSCDc9b51794-3cfa-4a34-b5bb-d523b5798c173
1366192clobazam 2.5 MG per 1 ML Oral SuspensionSYc9b51794-3cfa-4a34-b5bb-d523b5798c173
1366192clobazam 4 MG per 10 ML Oral SuspensionSYc9b51794-3cfa-4a34-b5bb-d523b5798c173

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-641-12317220641121 BOTTLE, GLASS in 1 CARTON (31722-641-12) / 120 mL in 1 BOTTLE, GLASS2020-02-240000-00-00NoNoCurrent