Approvals (Drugs@FDA)

RIVAROXABAN

LUPIN · RIVAROXABAN

ANDA208555Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA208555
Sponsor name
LUPIN
Submissions
  1. Submission type
    ORIG
    Submission number
    2
    Submission status
    AP
    Submission status date
    20250514
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
  2. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250303
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    003
    Reference drug
    No
    Brand name
    RIVAROXABAN
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      RIVAROXABAN
      Strength
      15MG
  2. Product number
    001
    Reference drug
    No
    Brand name
    RIVAROXABAN
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      RIVAROXABAN
      Strength
      2.5MG
  3. Product number
    004
    Reference drug
    No
    Brand name
    RIVAROXABAN
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      RIVAROXABAN
      Strength
      20MG
  4. Product number
    002
    Reference drug
    No
    Brand name
    RIVAROXABAN
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      RIVAROXABAN
      Strength
      10MG
Harmonized identifiers (openFDA)
Application number
ANDA208555
Brand name
RIVAROXABAN
Generic name
RIVAROXABAN
Manufacturer name
Lupin Pharmaceuticals, Inc.
Product NDC
68180-709
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
RIVAROXABAN
RxCUI
2059015
SPL ID
310f0bf6-9b0f-441b-afd7-b9a0f7905395
SPL set ID
702fed3e-ae25-49ba-98cc-562e0e244214
Package NDC
68180-709-09, 68180-709-06
Nui
N0000175635, N0000175637
Pharm class moa
Factor Xa Inhibitors [MoA]
Pharm class epc
Factor Xa Inhibitor [EPC]
UNII
9NDF7JZ4M3
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.