Label: tablet
- Packager: Food and Drug Administration
- This is a repackaged label.
- Source NDC Code(s): 58557864-2f15-2f84-5e50-76c4edd0, 830cc34e-b36d-27d5-9394-5601e840
- Category: INDEXING - PRODUCT CONCEPT
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 12, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL INDEXING DATA ELEMENTS SECTION
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INGREDIENTS AND APPEARANCE
Abstract Product Concept tablet Product Information Product Type INDEXING - PRODUCT CONCEPT Item Code (Source) 58557864-2f15-2f84-5e50-76c4edd0fb98 Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBUTYNIN CHLORIDE (UNII: L9F3D9RENQ) (OXYBUTYNIN - UNII:K9P6MC7092) OXYBUTYNIN CHLORIDE 5 mg Application Product Concept Product Information Product Type INDEXING - PRODUCT CONCEPT Item Code (Source) 830cc34e-b36d-27d5-9394-5601e840d8e5 Marketing Information Marketing Category Application Number or Monograph Citation ANDA ANDA075079 Application Product Concept Product Information Product Type INDEXING - PRODUCT CONCEPT Item Code (Source) 56236a1c-4fb8-726e-b59b-343f69e4c40c Marketing Information Marketing Category Application Number or Monograph Citation ANDA ANDA071655 Application Product Concept Product Information Product Type INDEXING - PRODUCT CONCEPT Item Code (Source) 79fbf949-e08e-7647-5b00-77d9277cd370 Marketing Information Marketing Category Application Number or Monograph Citation ANDA ANDA074625 Application Product Concept Product Information Product Type INDEXING - PRODUCT CONCEPT Item Code (Source) 0b05ee51-27cc-795b-f67f-b8fbebd82cc5 Marketing Information Marketing Category Application Number or Monograph Citation ANDA ANDA209823 Labeler - Food and Drug Administration (927645523)