Home NDC 51285-204-01 ParaGard T 380A
Product NDC 51285-204
Requested package NDC 51285-204-01
11-digit product format 512850204
Labeler code 51285
Product ID 51285-204_3d69e7f6-dcbe-4c3f-a8b8-54323a6e7b63
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Copper
Dosage form INTRAUTERINE DEVICE
Route INTRAUTERINE
Labeler Teva Women's Health, Inc.
Application NDA018680
Marketing category NDA
Marketing start 2004-01-01
Marketing end 2024-04-30
Substance COPPER
Active strength 313 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 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018680-001 PARAGARD T 380A COPPER 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N018680-001 D-193 2027-06-28
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018680-001 PARAGARD T 380A 309MG/COPPER SYSTEM / INTRAUTERINE RLD, RS 1984-11-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018680-001 PARAGARD T 380A 309MG/COPPER INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 1984-11-15 e64feba35796…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-18 06:07:40 2026-07 N018680-001 D-193 2027-06-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018680-001 D-193 2027-06-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018680-001 D-193 2027-06-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018680-001 D-193 2027-06-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018680-001 D-193 2027-06-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018680-001 D-193 2027-06-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018680-001 D-193 2027-06-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018680-001 D-193 2027-06-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018680-001 D-193 2027-06-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018680-001 D-193 2027-06-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018680-001 D-193 2027-06-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018680-001 D-193 2027-06-28 79d66fd596c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N018680-001 D-193 2027-06-28 a50c72e98297…
DailyMed Socrata Ingredients# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51285-204-01 51285020401 1 POUCH in 1 PACKAGE (51285-204-01) > 1 INTRAUTERINE DEVICE in 1 POUCH 1 pouch 2004-01-01 2024-04-30 No No Current