Approvals (Drugs@FDA)

SUGAMMADEX SODIUM

FRESENIUS KABI USA · SUGAMMADEX SODIUM

ANDA219448Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA219448
Sponsor name
FRESENIUS KABI USA
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260728
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    SUGAMMADEX SODIUM
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      SUGAMMADEX SODIUM
      Strength
      EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
Harmonized identifiers (openFDA)
Application number
ANDA219448
Brand name
SUGAMMADEX
Generic name
SUGAMMADEX
Manufacturer name
Fresenius Kabi USA, LLC
Product NDC
76045-219
Product type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Substance name
SUGAMMADEX SODIUM
RxCUI
2748156
SPL ID
d82ad889-b1e4-4f3e-8767-c8228a00a6a8
SPL set ID
8e685b67-6804-4d97-b43e-0259b3fe231f
Package NDC
76045-219-04, 76045-219-24, 76045-219-02, 76045-219-20
UNII
ERJ6X2MXV7
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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.