Approvals (Drugs@FDA)

ESOMEPRAZOLE MAGNESIUM

TORRENT · ESOMEPRAZOLE MAGNESIUM

ANDA212652Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA212652
Sponsor name
TORRENT
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250305
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    ESOMEPRAZOLE MAGNESIUM
    Reference standard
    No
    Dosage form
    FOR SUSPENSION, DELAYED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ESOMEPRAZOLE MAGNESIUM
      Strength
      EQ 10MG BASE/PACKET
Harmonized identifiers (openFDA)
Application number
ANDA212652
Brand name
ESOMEPRAZOLE MAGNESIUM FOR DELAYED-RELEASE ORAL SUSPENSION
Generic name
ESOMEPRAZOLE MAGNESIUM
Manufacturer name
Torrent Pharmaceuticals Limited
Product NDC
13668-548
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
ESOMEPRAZOLE MAGNESIUM
RxCUI
861568
SPL ID
e8ee6d82-9a16-4fa5-b5f2-3c315e0b6baa
SPL set ID
f907e633-4080-44ae-829f-141497876922
Package NDC
13668-548-94
UNII
R6DXU4WAY9
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

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.