Label: ALBUTEROL tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 70771-1511-1, 70771-1512-1, 70771-1512-5 - Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 27, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALBUTEROL
albuterol tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1511 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E) ALBUTEROL 2 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE (white to off-white) Score 2 pieces Shape ROUND (ROUND) Size 6mm Flavor Imprint Code 10;61 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1511-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/23/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208884 10/23/2020 ALBUTEROL
albuterol tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1512 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E) ALBUTEROL 4 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces Shape ROUND (ROUND) Size 9mm Flavor Imprint Code 10;62 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1512-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/23/2020 2 NDC:70771-1512-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 10/23/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208884 10/23/2020 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1511, 70771-1512) , MANUFACTURE(70771-1511, 70771-1512)
