FDA.reportPublic FDA data

ParaGard T 380A

Product NDC
59365-5128
11-digit product format
593655128
Labeler code
59365
Product ID
59365-5128_226b4d58-044f-4016-9da3-6fd6a37645dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Copper
Dosage form
INTRAUTERINE DEVICE
Route
INTRAUTERINE
Labeler
CooperSurgical, Inc.
Application
NDA018680
Marketing category
NDA
Marketing start
2017-11-02
Substance
COPPER
Active strength
313.4 mg/1
Pharmacologic classes
Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ParaGard T 380A
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COPPER313.4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii789U1901C5
Rxcui2267305, 2267310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59365-5128-12020-04-15C16284748780-19d75b9d0-1873-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PARAGARD® safely and effectively. See full prescribing information for PARAGARD. Paragard® (intrauterine copper contraceptive) Initial U.S. Approval: 1984
59365-5128-12020-01-31C16284748780-19d75b9d0-1873-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PARAGARD® safely and effectively. See full prescribing information for PARAGARD. Paragard® (intrauterine copper contraceptive) Initial U.S. Approval: 1984

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59365-5128-1ParaGard T 380A1 in 1 CARTONINTRAUTERINE DEVICE16
59365-5128-1ParaGard T 380A1 in 1 POUCHINTRAUTERINE DEVICE16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59365-5128-1EA - Each59365-5128fe9a15ab-4829-43c5-bd08-ee518f76571f12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59365-5128PARAGARD T 380A (COPPER) INTRAUTERINE DEVICE [COOPERSURGICAL, INC.]5Current NDC, Legacy NDC, 2 package rows20210115_5ea7ce51-b87a-485e-b841-99466a07a4b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2267305copper 313.4 MG Drug ImplantPSN5ea7ce51-b87a-485e-b841-99466a07a4b26
2267310PARAGARD 313.4 MG Drug ImplantPSN5ea7ce51-b87a-485e-b841-99466a07a4b26
2267310copper 313 MG Drug Implant [ParaGard]SBD5ea7ce51-b87a-485e-b841-99466a07a4b26
2267305copper 313 MG Drug ImplantSCD5ea7ce51-b87a-485e-b841-99466a07a4b26
2267310ParaGard 313 MG Drug ImplantSY5ea7ce51-b87a-485e-b841-99466a07a4b26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59365-5128-1593655128011 POUCH in 1 CARTON (59365-5128-1) / 1 INTRAUTERINE DEVICE in 1 POUCH1 pouch2017-11-020000-00-00NoNoCurrent