Label: OLMESARTAN MEDOXOMIL tablet, film coated
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NDC Code(s):
70771-1059-0,
70771-1059-1,
70771-1059-2,
70771-1059-3, view more70771-1059-5, 70771-1059-7, 70771-1059-9, 70771-1060-0, 70771-1060-1, 70771-1060-2, 70771-1060-3, 70771-1060-5, 70771-1060-7, 70771-1060-9, 70771-1061-0, 70771-1061-1, 70771-1061-2, 70771-1061-3, 70771-1061-5, 70771-1061-7, 70771-1061-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 13, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OLMESARTAN MEDOXOMIL
olmesartan medoxomil tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1059 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10) OLMESARTAN MEDOXOMIL 5 mg Inactive Ingredients Ingredient Name Strength HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 9mm Flavor Imprint Code 643 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1059-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/24/2017 2 NDC:70771-1059-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/24/2017 3 NDC:70771-1059-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/24/2017 4 NDC:70771-1059-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 04/24/2017 5 NDC:70771-1059-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 04/24/2017 6 NDC:70771-1059-7 10 in 1 CARTON 04/24/2017 6 NDC:70771-1059-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205192 04/24/2017 OLMESARTAN MEDOXOMIL
olmesartan medoxomil tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1060 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10) OLMESARTAN MEDOXOMIL 20 mg Inactive Ingredients Ingredient Name Strength HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 9mm Flavor Imprint Code 644 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1060-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/24/2017 2 NDC:70771-1060-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/24/2017 3 NDC:70771-1060-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/24/2017 4 NDC:70771-1060-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 04/24/2017 5 NDC:70771-1060-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 04/24/2017 6 NDC:70771-1060-7 10 in 1 CARTON 04/24/2017 6 NDC:70771-1060-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205192 04/24/2017 OLMESARTAN MEDOXOMIL
olmesartan medoxomil tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1061 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10) OLMESARTAN MEDOXOMIL 40 mg Inactive Ingredients Ingredient Name Strength HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape OVAL (OVAL) Size 15mm Flavor Imprint Code 645 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1061-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/24/2017 2 NDC:70771-1061-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/24/2017 3 NDC:70771-1061-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/24/2017 4 NDC:70771-1061-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 04/24/2017 5 NDC:70771-1061-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 04/24/2017 6 NDC:70771-1061-7 10 in 1 CARTON 04/24/2017 6 NDC:70771-1061-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205192 04/24/2017 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (863362789) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1059, 70771-1060, 70771-1061) , MANUFACTURE(70771-1059, 70771-1060, 70771-1061)
