Trientine Hydrochloride

Product NDC: 49884-060
11-digit product format: 498840060
Labeler code: 49884
Product ID: 49884-060_c630e57d-26e9-4670-9d3d-fa574857f752
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trientine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Par Health USA, LLC
Application: ANDA210096
Marketing category: ANDA
Marketing start: 2019-09-27
Marketing end: 2027-05-31
Substance: TRIENTINE HYDROCHLORIDE
Active strength: 250 mg/1
Pharmacologic classes: Copper Chelating Activity [MoA], Copper Chelator [EPC], Metal Chelating Activity [MoA]
NDC exclude flag: No
Current FDA listing: Yes

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
A210096-001	TRIENTINE HYDROCHLORIDE	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL			2019-09-25

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL		2019-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-09-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210096-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL		2019-09-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210096-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210096-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210096-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210096-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210096-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210096-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210096-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210096-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210096-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210096-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210096-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210096-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210096-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210096-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210096-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210096-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210096-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210096-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210096-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210096-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210096-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210096-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210096-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210096-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210096-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210096-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210096-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210096-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210096-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210096-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210096-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210096-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210096-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210096-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210096-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210096-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210096-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210096-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Trientine Hydrochloride

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRIENTINE HYDROCHLORIDE	250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
HC3NX54582	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313472	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
431c7f66-d58b-4eb0-b195-d164788f9acf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
a68ac59a-f073-3e03-cd2c-70c7eb201ed2	Product name	8	20230314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49884-060-01	Trientine Hydrochloride	100 in 1 BOTTLE	CAPSULE	100		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-060-01	EA - Each	49884-060	477ac2a9-14e2-45e9-9fa9-a0ad99b04eac	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49884-060	TRIENTINE HYDROCHLORIDE CAPSULE [ENDO USA, INC.]	9	Current NDC, Legacy NDC, 1 package rows	20250109_431c7f66-d58b-4eb0-b195-d164788f9acf.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trientine Hydrochloride	TRIENTINE HYDROCHLORIDE	Par Health USA, LLC	431c7f66-d58b-4eb0-b195-d164788f9acf	2024-11-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210096 application number: ANDA210096 ndc (product): 49884-060

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HC3NX54582	TRIENTINE HYDROCHLORIDE	38260-01-4	TRIENTINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313472	trientine HCl 250 MG Oral Capsule	PSN	431c7f66-d58b-4eb0-b195-d164788f9acf	10
313472	trientine hydrochloride 250 MG Oral Capsule	SCD	431c7f66-d58b-4eb0-b195-d164788f9acf	10
313472	trientine HCl 250 MG Oral Capsule	SY	431c7f66-d58b-4eb0-b195-d164788f9acf	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-060-01	49884006001	100 CAPSULE in 1 BOTTLE (49884-060-01)	100 capsule	2019-09-27	2027-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trientine Hydrochloride Capsules USP, 250 mg Rx Only	Par Health USA, LLC	2024-11-29	HUMAN PRESCRIPTION DRUG LABEL	10