Label: capsule, delayed release
capsule, delayed release
granule, delayed release
granule, delayed release
granule, delayed release
granule, delayed release
granule, delayed release























  • Category: INDEXING - PRODUCT CONCEPT
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 12, 2017

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  • SPL INDEXING DATA ELEMENTS SECTION

  • INGREDIENTS AND APPEARANCE
    Abstract Product Concept
      capsule, delayed release
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)f9c60630-6ff5-39b5-f6fd-34bf265ad271
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE20 mg
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)ea4ed971-74d7-b441-63d1-f51c7e701fa8
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    NDANDA021153
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)52bc7b28-20cf-255d-d1d3-0297b0e83d67
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA078003
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)29bc8fc2-42b6-ba2e-9650-4d3577991d52
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA078936
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)dc04a907-1e10-523d-be3f-8ffd02852c0b
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA202784
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)03f66dd6-6502-8098-329b-f2574d85f0aa
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA078279
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)9b242791-b51d-053c-c950-efed21aad165
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA203636
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)9fef403b-9b73-32d5-305e-2aa796720b9b
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA205606
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)b7c21a8a-7eb5-93fd-b8a3-60a86c6ddc66
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA205563
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)68f06322-2ac2-cb97-05c5-7df0a7da19b3
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA208333
    Abstract Product Concept
      capsule, delayed release
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)b7b7c95f-cab7-dda6-f048-cfaeecc97706
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE40 mg
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)cbe12286-ff62-b818-894f-5766e45c0a2b
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    NDANDA021153
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)69bb816d-e2b7-2d24-933f-3c6489ec6256
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA078003
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)8a49b616-1949-37ab-d7e9-e78c98a70d9d
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA078936
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)59d1ba99-202b-1e16-2e5c-7f3c606461a0
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA202784
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)8cbdc183-ef29-139d-c69b-103f598e2574
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA078279
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)3d1f7f40-c60b-d802-7c44-43e7a9185e23
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA203636
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)03a06676-c5c8-ddf3-a4fc-62a46e56e5ad
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA205606
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)52460d4e-c87d-80ef-0166-318cb8754507
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA205563
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)181f17dd-652e-6b74-ba3f-b1d47a74a5e3
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA208333
    Abstract Product Concept
      granule, delayed release
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)63c4e71c-335b-de22-c726-3ec86f6b21b5
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE2.5 mg
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)fe50be60-a1af-327e-02c0-627bd4a1d859
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    NDANDA021957
    Abstract Product Concept
      granule, delayed release
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)60b281b4-9a53-05f4-7b83-90ffb50d440a
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE5 mg
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)5009ea27-4028-a54b-74c1-c65a636c13de
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    NDANDA021957
    Abstract Product Concept
      granule, delayed release
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)3ad4553d-ea35-46fa-3c0d-6aa52843e9cb
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE10 mg
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)e4292909-74e1-085a-4cd3-ffd8dde97a28
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    NDANDA022101
    Abstract Product Concept
      granule, delayed release
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)32683610-0888-1090-0a2e-d25758ca5e46
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE20 mg
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)64c6b1a6-2cd5-4f37-bb3c-461ea9a091ed
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    NDANDA021957
    Abstract Product Concept
      granule, delayed release
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)d7e7d73a-9d11-7772-e48c-9dfc5fb4eca9
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE40 mg
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)59ceedda-e04e-ff08-613a-d1414a743af3
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    NDANDA021957
    Labeler - Food and Drug Administration (927645523)
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