Approvals (Drugs@FDA)

METHOTREXATE SODIUM

ALEMBIC · METHOTREXATE SODIUM

ANDA217552Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA217552
Sponsor name
ALEMBIC
Submissions
  1. Submission type
    SUPPL
    Submission number
    5
    Submission status
    AP
    Submission status date
    20260527
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  2. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240603
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    METHOTREXATE SODIUM
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      METHOTREXATE SODIUM
      Strength
      EQ 2.5MG BASE
Harmonized identifiers (openFDA)
Application number
ANDA217552
Brand name
METHOTREXATE
Generic name
METHOTREXATE
Manufacturer name
Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited
Product NDC
62332-730, 46708-730
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
METHOTREXATE SODIUM
RxCUI
105585
SPL ID
9dd138d6-6889-400e-a994-9931af68244a, ff55c573-dc84-4ff3-9d10-2b24c47dd679
SPL set ID
04a95db9-a124-4b97-bd71-1c37a6b3b0c8, ff55c573-dc84-4ff3-9d10-2b24c47dd679
Package NDC
62332-730-36, 62332-730-31, 46708-730-36, 46708-730-31
UNII
3IG1E710ZN
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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.