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Minocin

MINOCIN Minocycline For Injection 100 Mg/Vial

Approved
Approval ID

e415c323-8219-464b-9e3e-72c5a796cdaa

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 28, 2021

Manufacturers
FDA

Melinta Therapeutics, LLC

DUNS: 079949853

Products 1

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

minocycline hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70842-160
Application NumberNDA050444
Product Classification
M
Marketing Category
C73594
G
Generic Name
minocycline hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 28, 2021
FDA Product Classification

INGREDIENTS (3)

MINOCYCLINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 0020414E5U
Classification: ACTIM
MAGNESIUM SULFATE HEPTAHYDRATEInactive
Quantity: 269 mg in 1 1
Code: SK47B8698T
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

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Minocin - FDA Drug Approval Details