ParaGard T 380A

Product NDC: 51285-204
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51285-204		D	Discontinued by firm		2026-08-11
excluded package	package	51285-204	51285-204-01	D	Discontinued by firm		2026-08-11

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51285-204-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51285-204-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51285-204-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51285-204-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51285-204-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51285-204-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51285-204-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51285-204-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51285-204-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51285-204-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51285-204-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51285-204-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018680-001	PARAGARD T 380A	309MG/COPPER	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	1984-11-15	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51285-204-01	EA - Each	51285-204	c0a53ca3-8277-48b8-ae9e-488c822b9ada	1	2012-07-24
51285-204-02	EA - Each	51285-204	3e575fe9-6834-440f-b48b-57a913ea25ba	1	2014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
COPPER	ACTIVE INGREDIENT	789U1901C5	PARAGARD T 380A (COPPER) INTRAUTERINE DEVICE [TEVA WOMEN'S HEALTH, INC.]	11
COPPER	ACTIVE MOIETY	789U1901C5	PARAGARD T 380A (COPPER) INTRAUTERINE DEVICE [TEVA WOMEN'S HEALTH, INC.]	11
BARIUM SULFATE	INACTIVE INGREDIENT	25BB7EKE2E	PARAGARD T 380A (COPPER) INTRAUTERINE DEVICE [TEVA WOMEN'S HEALTH, INC.]	11
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PARAGARD T 380A (COPPER) INTRAUTERINE DEVICE [TEVA WOMEN'S HEALTH, INC.]	11

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ParaGard T 380A	COPPER	CooperSurgical, Inc.	3c420b53-c95e-46af-aebd-73741be58391	2024-06-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018680 application number: NDA018680
ParaGard T 380A	COPPER	CooperSurgical, Inc.	5ea7ce51-b87a-485e-b841-99466a07a4b2	2019-09-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018680 application number: NDA018680

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
789U1901C5	COPPER	7440-50-8	COPPER

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ParaGard ® T 380A INTRAUTERINE COPPER CONTRACEPTIVE	Teva Women's Health LLC	2014-09-01	HUMAN PRESCRIPTION DRUG LABEL	15