NDC Code(s) : 59365-5128-1
Packager : CooperSurgical, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ParaGard T 380ACopper INTRAUTERINE DEVICE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59365-5128
Route of Administration INTRAUTERINE DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COPPER(UNII: 789U1901C5)
(COPPER - UNII:789U1901C5) 		COPPER313.4 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
BARIUM SULFATE(UNII: 25BB7EKE2E)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59365-5128-11 in 1 CARTON 11/02/2017
11 in 1 POUCH Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018680 11/02/2017

LABELER - CooperSurgical, Inc.(801895244)

PRINCIPAL DISPLAY PANEL

PARAGARD
Intrauterine Copper Contraceptive
1 Unit

PARAGARD Intrauterine Copper Contraceptive 1 Unit

ParaGard® T380A Intrauterine Copper Contraceptive Single Carton Text

CooperSurgical, Inc.

95 Corporate Drive, Trumbull, CT 06611 USA

1

UNIT

PARAGARD ® T380A

intrauterine copper contraceptive

NDC 59365-5128-1

Each unit wound with approximately 176 mg of copper wire. In addition, a single copper sleeve is swaged on each of the two transverse arms. Each sleeve contains approximately 68.7 mg of copper.

The total surface area of copper on the device is 380 ± 23mm2. IMPORTANT: To be inserted in the uterus only by a licensed clinician or under the supervision of a physician. See detailed instructionsf  or use.

NOTE: A Patient Package Insert is provided with each unit. Please ensure that this package insert is provided to the patient. Review patient brochure with each patient before insertion.

Store at controlled room temperature: 59° to 86°F (15° to 30°C)

CooperSurgical, Inc., 95 Corporate Drive, Trumbull, CT 06611