Label: LOPERAMIDE HYDROCHLORIDE capsule
- NDC Code(s): 70771-1769-1, 70771-1769-2, 70771-1769-4, 70771-1769-5
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 19, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LOPERAMIDE HYDROCHLORIDE
loperamide hydrochloride capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1769 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE 2 mg Inactive Ingredients Ingredient Name Strength FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) POVIDONE K30 (UNII: U725QWY32X) SHELLAC (UNII: 46N107B71O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color YELLOW (cream opaque cap) , YELLOW (cream opaque body) Score no score Shape CAPSULE Size 16mm Flavor Imprint Code 1701 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1769-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/25/2023 2 NDC:70771-1769-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 06/25/2023 3 NDC:70771-1769-4 10 in 1 CARTON 06/25/2023 3 NDC:70771-1769-2 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 ANDA217471 06/25/2023 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1769) , MANUFACTURE(70771-1769)
