Label: LUBIPROSTONE capsule
- NDC Code(s): 70771-1763-1, 70771-1763-6, 70771-1764-1, 70771-1764-6
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 24, 2023
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INGREDIENTS AND APPEARANCE
LUBIPROSTONE
lubiprostone capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1763 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LUBIPROSTONE (UNII: 7662KG2R6K) (LUBIPROSTONE - UNII:7662KG2R6K) LUBIPROSTONE 8 ug Inactive Ingredients Ingredient Name Strength 1,4-SORBITAN (UNII: AV0YTZ4E6J) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color PINK (light pink to pink colored) Score no score Shape OVAL Size 9mm Flavor Imprint Code 8 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1763-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 03/23/2023 2 NDC:70771-1763-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/23/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214131 03/23/2023 LUBIPROSTONE
lubiprostone capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1764 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LUBIPROSTONE (UNII: 7662KG2R6K) (LUBIPROSTONE - UNII:7662KG2R6K) LUBIPROSTONE 24 ug Inactive Ingredients Ingredient Name Strength 1,4-SORBITAN (UNII: AV0YTZ4E6J) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) Product Characteristics Color YELLOW (light yellow colored) Score no score Shape OVAL Size 9mm Flavor Imprint Code 24 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1764-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 03/23/2023 2 NDC:70771-1764-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/23/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214131 03/23/2023 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1763, 70771-1764) , MANUFACTURE(70771-1763, 70771-1764)
