Label: ROFLUMILAST tablet
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- NDC Code(s): 70771-1674-3, 70771-1674-9
- Packager: Cadila Healthcare Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 18, 2022
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INGREDIENTS AND APPEARANCE
ROFLUMILAST
roflumilast tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1674 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ROFLUMILAST (UNII: 0P6C6ZOP5U) (ROFLUMILAST - UNII:0P6C6ZOP5U) ROFLUMILAST 500 ug Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLOXAMER 407 (UNII: TUF2IVW3M2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE (off-white) Score no score Shape ROUND Size 6mm Flavor Imprint Code T5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1674-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/03/2022 2 NDC:70771-1674-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 10/03/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208303 10/03/2022 Labeler - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 863362789 ANALYSIS(70771-1674) , MANUFACTURE(70771-1674)
