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Sterile Cord Blood Collection Unit (MSC127D)

Sterile Cord Blood Collection Unit (MSC127D)

Approved
Approval ID

75a008b2-9666-4bfa-ab18-6d09b43b2215

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 21, 2017

Manufacturers
FDA

Maco Productions

DUNS: 265492868

Products 1

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

Anticoagulant Citrate Phosphate Dextrose Solution

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code14498-003
Application NumberBN125552
Product Classification
M
Marketing Category
C73594
G
Generic Name
Anticoagulant Citrate Phosphate Dextrose Solution
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 21, 2017
FDA Product Classification

INGREDIENTS (4)

SODIUM CITRATEActive
Quantity: 0.92 g in 35 mL
Code: 1Q73Q2JULR
Classification: ACTIB
CITRIC ACID MONOHYDRATEActive
Quantity: 114.5 mg in 35 mL
Code: 2968PHW8QP
Classification: ACTIM
DEXTROSE MONOHYDRATEActive
Quantity: 0.89 g in 35 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEActive
Quantity: 87.9 mg in 35 mL
Code: 5QWK665956
Classification: ACTIB

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Sterile Cord Blood Collection Unit (MSC127D) - FDA Drug Approval Details