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Dexamethasone Sodium Phosphate

Dexamethasone Sodium Phosphate Injection, USP Rx only

Approved
Approval ID

69344707-904d-7ba2-e053-2a91aa0a31f4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 23, 2023

Manufacturers
FDA

Medical Purchasing Solutions, LLC

DUNS: 601458529

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Dexamethasone Sodium Phosphate

PRODUCT DETAILS

NDC Product Code71872-7091
Application NumberANDA087702
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMay 23, 2023
Generic NameDexamethasone Sodium Phosphate

INGREDIENTS (7)

SODIUM CITRATEInactive
Quantity: 16.5 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT
SODIUM SULFITEInactive
Quantity: 1.5 mg in 1 mL
Code: VTK01UQK3G
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 10.42 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
DEXAMETHASONE SODIUM PHOSPHATEActive
Quantity: 10 mg in 1 mL
Code: AI9376Y64P
Classification: ACTIR

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Dexamethasone Sodium Phosphate - FDA Drug Approval Details