ParaGard T 380A
ParaGard T 380A INTRAUTERINE COPPER CONTRACEPTIVE
Approved
Approval ID
2b009ddb-378e-40d8-a8d8-00211f10e06c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2014
Manufacturers
FDA
Teva Women's Health LLC
DUNS: 017038951
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Copper
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51285-204
Application NumberNDA018680
Product Classification
M
Marketing Category
C73594
G
Generic Name
Copper
Product Specifications
Route of AdministrationINTRAUTERINE
Effective DateJune 5, 2023
FDA Product Classification
INGREDIENTS (3)
BARIUM SULFATEInactive
Code: 25BB7EKE2E
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
COPPERActive
Quantity: 313.4 mg in 1 1
Code: 789U1901C5
Classification: ACTIB