Approvals (Drugs@FDA)

POTASSIUM CITRATE

RISING · POTASSIUM CITRATE

ANDA077440Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA077440
Sponsor name
RISING
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20060608
  2. Submission type
    SUPPL
    Submission number
    5
    Submission status
    AP
    Submission status date
    20240530
    Review priority
    UNKNOWN
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
Products
  1. Product number
    002
    Reference drug
    No
    Brand name
    POTASSIUM CITRATE
    Reference standard
    No
    Dosage form
    TABLET, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      POTASSIUM CITRATE
      Strength
      10MEQ
  2. Product number
    001
    Reference drug
    No
    Brand name
    POTASSIUM CITRATE
    Reference standard
    No
    Dosage form
    TABLET, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      POTASSIUM CITRATE
      Strength
      5MEQ
Harmonized identifiers (openFDA)
Application number
ANDA077440
Brand name
POTASSIUM CITRATE
Generic name
POTASSIUM CITRATE
Manufacturer name
Rising Pharma Holdings, Inc.
Product NDC
16571-864, 16571-865
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
POTASSIUM CITRATE
RxCUI
199376, 199381
SPL ID
73e193b2-7b67-4a83-9f5c-9b20ae32e779
SPL set ID
164d9d05-fbb1-4d99-8ba3-ff9c172aa8ca
Package NDC
16571-864-01, 16571-865-01
UNII
EE90ONI6FF
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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.