NDC 59365-5128

ParaGard T 380A

Copper

ParaGard T 380A is a Intrauterine Intrauterine Device in the Human Prescription Drug category. It is labeled and distributed by Coopersurgical, Inc.. The primary component is Copper.

Product ID59365-5128_80759d3a-13e1-49ea-b4dd-2fdc8b10d5f8
NDC59365-5128
Product TypeHuman Prescription Drug
Proprietary NameParaGard T 380A
Generic NameCopper
Dosage FormIntrauterine Device
Route of AdministrationINTRAUTERINE
Marketing Start Date2017-11-02
Marketing CategoryNDA / NDA
Application NumberNDA018680
Labeler NameCooperSurgical, Inc.
Substance NameCOPPER
Active Ingredient Strength313 mg/1
Pharm ClassesCopper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 59365-5128-1

1 POUCH in 1 CARTON (59365-5128-1) > 1 INTRAUTERINE DEVICE in 1 POUCH
Marketing Start Date2017-11-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59365-5128-1 [59365512801]

ParaGard T 380A INTRAUTERINE DEVICE
Marketing CategoryNDA
Application NumberNDA018680
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-11-02
Inactivation Date2020-01-31
Reactivation Date2020-04-15

Drug Details

Active Ingredients

IngredientStrength
COPPER313.4 mg/1

OpenFDA Data

SPL SET ID:5ea7ce51-b87a-485e-b841-99466a07a4b2
Manufacturer
UNII

Pharmacological Class

  • Copper [CS]
  • Copper-containing Intrauterine Device [EPC]
  • Decreased Embryonic Implantation [PE]
  • Decreased Sperm Motility [PE]
  • Inhibit Ovum Fertilization [PE]

NDC Crossover Matching brand name "ParaGard T 380A" or generic name "Copper"

NDCBrand NameGeneric Name
51285-204ParaGard T 380ACopper
59365-5128ParaGard T 380ACopper
79234-0002Antibacterial PVC filmcopper
64117-958Cramps SpasmsCOPPER
0220-1613Cuprum metallicumCOPPER
0220-1616Cuprum metallicumCOPPER
0220-1623Cuprum metallicumCOPPER
0220-1624Cuprum metallicumCOPPER
0220-1627Cuprum metallicumCOPPER
0220-1628Cuprum metallicumCOPPER
0220-1631Cuprum metallicumCOPPER
0220-1635Cuprum metallicumCOPPER
0220-1636Cuprum metallicumCOPPER
0220-1648Cuprum metallicumCOPPER
0220-1651Cuprum metallicumCOPPER
0220-1652Cuprum metallicumCOPPER
10191-1411CUPRUM METALLICUMCOPPER
10191-1413CUPRUM METALLICUMCOPPER
62106-5020CUPRUM METALLICUMCopper
68428-349Cuprum metallicumCOPPER
71919-243Cuprum metallicumCOPPER
68428-140Cuprum Metallicum Kit RefillCOPPER
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