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

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: ParaGard T 380A
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
COPPER	313.4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
789U1901C5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2267305	Internal RxNorm lookup
2267310	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5ea7ce51-b87a-485e-b841-99466a07a4b2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c599c4a0-705d-4ebb-ab1f-977af038f96a	Product name	1	20251124
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1	Product name	1	20201123
85bed648-23ca-4804-98e6-e36aee999cad	Product name	1	20190717
80de93b4-8a94-428d-beb7-d644353ee70b	Product name	1	20180424
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688	Product name	1	20170522
db8eb201-78c7-4590-8a71-fac0a539bd8c	Product name	1	20170404
141092be-5eb5-452e-9f69-2d350aa70a87	Product name	1	20161208

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2020-04-15	These 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
2020-04-15	These 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
2020-01-31	These 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
2020-01-31	These 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 NDC	Product	Description	Form	Quantity	Strength	SPL version
59365-5128-1	ParaGard T 380A	1 in 1 CARTON	INTRAUTERINE DEVICE	1		6
59365-5128-1	ParaGard T 380A	1 in 1 POUCH	INTRAUTERINE DEVICE	1		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59365-5128-1	EA - Each	59365-5128	fe9a15ab-4829-43c5-bd08-ee518f76571f	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59365-5128	PARAGARD T 380A (COPPER) INTRAUTERINE DEVICE [COOPERSURGICAL, INC.]	5	Current NDC, Legacy NDC, 2 package rows	20210115_5ea7ce51-b87a-485e-b841-99466a07a4b2.zip

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 ndc (product): 59365-5128

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2267305	copper 313.4 MG Drug Implant	PSN	5ea7ce51-b87a-485e-b841-99466a07a4b2	6
2267310	PARAGARD 313.4 MG Drug Implant	PSN	5ea7ce51-b87a-485e-b841-99466a07a4b2	6
2267310	copper 313 MG Drug Implant [ParaGard]	SBD	5ea7ce51-b87a-485e-b841-99466a07a4b2	6
2267305	copper 313 MG Drug Implant	SCD	5ea7ce51-b87a-485e-b841-99466a07a4b2	6
2267310	ParaGard 313 MG Drug Implant	SY	5ea7ce51-b87a-485e-b841-99466a07a4b2	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59365-5128-1	59365512801	1 POUCH in 1 CARTON (59365-5128-1) / 1 INTRAUTERINE DEVICE in 1 POUCH	1 pouch	2017-11-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ParaGard T 380A - CooperSurgical, Inc.	CooperSurgical, Inc.	2019-09-09	HUMAN PRESCRIPTION DRUG LABEL	7