FDA.reportPublic FDA data

Clobazam

Product NDC
68180-158
11-digit product format
681800158
Labeler code
68180
Product ID
68180-158_ce8d2e9b-0cf3-4206-9523-6f0df27953b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobazam
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA210545
Marketing category
ANDA
Marketing start
2019-05-08
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOBAZAM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2MRO291B4U
Rxcui199450, 246172

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
68180-158-01Clobazam1 in 1 CARTONTABLET115
68180-158-01Clobazam100 in 1 BOTTLETABLET10015
68180-158-02Clobazam500 in 1 BOTTLETABLET50015
68180-158-02Clobazam1 in 1 CARTONTABLET115
68180-158-06Clobazam1 in 1 CARTONTABLET115
68180-158-06Clobazam30 in 1 BOTTLETABLET3015
68180-158-07Clobazam1 in 1 CARTONTABLET115
68180-158-07Clobazam60 in 1 BOTTLETABLET6015
68180-158-09Clobazam90 in 1 BOTTLETABLET9015
68180-158-09Clobazam1 in 1 CARTONTABLET115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-158-01EA - Each68180-1585774759e-83bd-4ae2-9a8e-fdd9c53492f012019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-158CLOBAZAM TABLET [LUPIN PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 10 package rows20250309_d9e03a2a-3fea-4c98-ab71-415e6ebda3e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199450cloBAZam 10 MG Oral TabletPSNd9e03a2a-3fea-4c98-ab71-415e6ebda3e015
246172cloBAZam 20 MG Oral TabletPSNd9e03a2a-3fea-4c98-ab71-415e6ebda3e015
199450clobazam 10 MG Oral TabletSCDd9e03a2a-3fea-4c98-ab71-415e6ebda3e015
246172clobazam 20 MG Oral TabletSCDd9e03a2a-3fea-4c98-ab71-415e6ebda3e015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-158-01681800158011 BOTTLE in 1 CARTON (68180-158-01) / 100 TABLET in 1 BOTTLE1 bottle2019-05-080000-00-00NoNoCurrent
68180-158-02681800158021 BOTTLE in 1 CARTON (68180-158-02) > 500 TABLET in 1 BOTTLE1 bottle2019-05-080000-00-00NoNoCurrent
68180-158-06681800158061 BOTTLE in 1 CARTON (68180-158-06) > 30 TABLET in 1 BOTTLE1 bottle2019-05-080000-00-00NoNoCurrent
68180-158-07681800158071 BOTTLE in 1 CARTON (68180-158-07) > 60 TABLET in 1 BOTTLE1 bottle2019-05-080000-00-00NoNoCurrent
68180-158-09681800158091 BOTTLE in 1 CARTON (68180-158-09) > 90 TABLET in 1 BOTTLE1 bottle2019-05-080000-00-00NoNoCurrent