Label: CLOBAZAM tablet
- NDC Code(s): 70771-1440-1, 70771-1441-1
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: CIV
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 20, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Medication Guide: HTML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- SPL MEDGUIDE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CLOBAZAM
clobazam tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1440 Route of Administration ORAL DEA Schedule CIV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOBAZAM (UNII: 2MRO291B4U) (CLOBAZAM - UNII:2MRO291B4U) CLOBAZAM 10 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE (OFF-WHITE) Score 2 pieces Shape CAPSULE (MODIFIED CAPSULE) Size 9mm Flavor Imprint Code 13;25 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1440-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/22/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211449 10/22/2018 CLOBAZAM
clobazam tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1441 Route of Administration ORAL DEA Schedule CIV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOBAZAM (UNII: 2MRO291B4U) (CLOBAZAM - UNII:2MRO291B4U) CLOBAZAM 20 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE (OFF-WHITE) Score 2 pieces Shape CAPSULE (MODIFIED CAPSULE) Size 11mm Flavor Imprint Code 13;26 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1441-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/22/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211449 10/22/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (863362789) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1440, 70771-1441) , MANUFACTURE(70771-1440, 70771-1441)
