FDA Orange Book
Is there a generic for ParaGard T 380A?
ParaGard T 380A contains copper. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for ParaGard T 380A (copper). The Orange Book shows its last listed exclusivity ends June 28, 2027.
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ParaGard T 380A products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| system, intrauterine | 309MG/COPPER | Marketed (Rx) | None | 0 | None |
NDA 018680, held by COOPERSURGICAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
ParaGard T 380A exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| D-193 | New dosing schedule | June 28, 2027 | 018680 |
ParaGard T 380A NDC codes
Questions
Is there a generic for ParaGard T 380A?
No. The Orange Book lists no active FDA-approved generic (ANDA) for ParaGard T 380A (copper). The Orange Book shows its last listed exclusivity ends June 28, 2027.
What is the generic name for ParaGard T 380A?
The active ingredient in ParaGard T 380A is copper, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.