FDA.reportPublic FDA data

Clobazam

Product NDC
68094-074
11-digit product format
680940074
Labeler code
68094
Product ID
68094-074_53326439-6544-44fa-b13c-6ea7517f4187
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobazam
Dosage form
SUSPENSION
Route
ORAL
Labeler
Precision Dose, Inc.
Application
ANDA210039
Marketing category
ANDA
Marketing start
2025-03-10
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOBAZAM2.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2MRO291B4U
Rxcui1366192

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
713032fb-f461-4501-be8a-ca575cddec45Product name720211028
f324c243-b420-476a-968a-bb1445dcc148Product name120190211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68094-074-01Clobazam4 mL in 1 SYRINGE, PLASTICSUSPENSION42
68094-074-01Clobazam1 in 1 BAGSUSPENSION12
68094-074-58Clobazam50 in 1 CASESUSPENSION502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-074-01ML - Milliliter68094-07477d7dae4-0810-4b74-a525-1a8c0e174b5712025-05-14
68094-074-58ML - Milliliter68094-07476e74da1-69ec-42e2-b91e-28b6ec16da2812025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-074CLOBAZAM SUSPENSION [PRECISION DOSE, INC.]1Current NDC, 3 package rows20250310_6332e71c-3b37-422c-838c-8a2489ac6009.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366192cloBAZam 2.5 MG in 1 mL Oral SuspensionPSN6332e71c-3b37-422c-838c-8a2489ac60092
1366192clobazam 2.5 MG/ML Oral SuspensionSCD6332e71c-3b37-422c-838c-8a2489ac60092
1366192clobazam 2.5 MG per 1 ML Oral SuspensionSY6332e71c-3b37-422c-838c-8a2489ac60092
1366192clobazam 4 MG per 10 ML Oral SuspensionSY6332e71c-3b37-422c-838c-8a2489ac60092

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68094-074-01680940074014 mL in 1 SYRINGE, PLASTIC4 mlHistorical
68094-074-586809400745850 BAG in 1 CASE (68094-074-58) / 1 SYRINGE, PLASTIC in 1 BAG (68094-074-01) / 4 mL in 1 SYRINGE, PLASTIC50 bag2025-03-10NoNoHistorical