Label: METHENAMINE HIPPURATE tablet
- NDC Code(s): 70771-1919-1
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 12, 2025
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
METHENAMINE HIPPURATE
methenamine hippurate tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1919 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHENAMINE HIPPURATE (UNII: M329791L57) (METHENAMINE - UNII:J50OIX95QV) METHENAMINE HIPPURATE 1 g Inactive Ingredients Ingredient Name Strength CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color WHITE (WHITE TO OFF WHITE) Score 2 pieces Shape CAPSULE (MODIFIED CAPSULE SHAPE) Size 19mm Flavor Imprint Code II;C Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1919-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/12/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA219661 03/12/2025 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Pharmaceuticals Limited 650173735 MANUFACTURE(70771-1919) , ANALYSIS(70771-1919)
