Trientine Hydrochloride

Product NDC: 16571-810
11-digit product format: 165710810
Labeler code: 16571
Product ID: 16571-810_96619f61-e1f2-4ed3-9a81-c05077c8cbcb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trientine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA212238
Marketing category: ANDA
Marketing start: 2021-03-30
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
Listing certified through: 2026-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212238-001	TRIENTINE HYDROCHLORIDE	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20
A212238-002	TRIENTINE HYDROCHLORIDE	TRIENTINE HYDROCHLORIDE	500MG	CAPSULE / ORAL		RS	2023-09-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A212238-001	AB

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 · 59 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	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212238-002	TRIENTINE HYDROCHLORIDE	500MG	CAPSULE / ORAL		RS	2023-09-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212238-002	TRIENTINE HYDROCHLORIDE	500MG	CAPSULE / ORAL		RS	2023-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212238-002	TRIENTINE HYDROCHLORIDE	500MG	CAPSULE / ORAL			2023-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212238-002	TRIENTINE HYDROCHLORIDE	500MG	CAPSULE / ORAL			2023-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212238-002	TRIENTINE HYDROCHLORIDE	500MG	CAPSULE / ORAL			2023-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212238-002	TRIENTINE HYDROCHLORIDE	500MG	CAPSULE / ORAL			2023-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212238-002	TRIENTINE HYDROCHLORIDE	500MG	CAPSULE / ORAL			2023-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212238-002	TRIENTINE HYDROCHLORIDE	500MG	CAPSULE / ORAL			2023-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212238-002	TRIENTINE HYDROCHLORIDE	500MG	CAPSULE / ORAL			2023-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212238-002	TRIENTINE HYDROCHLORIDE	500MG	CAPSULE / ORAL			2023-09-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212238-002	TRIENTINE HYDROCHLORIDE	500MG	CAPSULE / ORAL			2023-09-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212238-002	TRIENTINE HYDROCHLORIDE	500MG	CAPSULE / ORAL			2023-09-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212238-002	TRIENTINE HYDROCHLORIDE	500MG	CAPSULE / ORAL			2023-09-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212238-002	TRIENTINE HYDROCHLORIDE	500MG	CAPSULE / ORAL			2023-09-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212238-002	TRIENTINE HYDROCHLORIDE	500MG	CAPSULE / ORAL			2023-09-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212238-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-02-20	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212238-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212238-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212238-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212238-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212238-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212238-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212238-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212238-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212238-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212238-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212238-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212238-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212238-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212238-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212238-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212238-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212238-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212238-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212238-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212238-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212238-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212238-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212238-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212238-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212238-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212238-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212238-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212238-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212238-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212238-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212238-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212238-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212238-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212238-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212238-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212238-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212238-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212238-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Trientine Hydrochloride
Listing expiration: 2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313472	Internal RxNorm lookup
2619912	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
f33c1322-f7c0-4684-afc8-8caa3f4023dc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
16571-810-01	Trientine Hydrochloride	100 in 1 BOTTLE	CAPSULE	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-810-01	EA - Each	16571-810	78b27a46-e543-499e-81a0-3a724aab7f55	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16571-810	TRIENTINE HYDROCHLORIDE CAPSULE [RISING PHARMA HOLDINGS, INC.]	5	Current NDC, Legacy NDC, 1 package rows	20230926_f33c1322-f7c0-4684-afc8-8caa3f4023dc.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	Rising Pharma Holdings, Inc.	f33c1322-f7c0-4684-afc8-8caa3f4023dc	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212238 application number: ANDA212238 ndc (product): 16571-810

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	f33c1322-f7c0-4684-afc8-8caa3f4023dc	6
2619912	trientine HCl 500 MG Oral Capsule	PSN	f33c1322-f7c0-4684-afc8-8caa3f4023dc	6
313472	trientine hydrochloride 250 MG Oral Capsule	SCD	f33c1322-f7c0-4684-afc8-8caa3f4023dc	6
2619912	trientine hydrochloride 500 MG Oral Capsule	SCD	f33c1322-f7c0-4684-afc8-8caa3f4023dc	6
313472	trientine HCl 250 MG Oral Capsule	SY	f33c1322-f7c0-4684-afc8-8caa3f4023dc	6
2619912	trientine HCl 500 MG Oral Capsule	SY	f33c1322-f7c0-4684-afc8-8caa3f4023dc	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16571-810-01	16571081001	100 CAPSULE in 1 BOTTLE (16571-810-01)	100 capsule	2021-03-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trientine Hydrochloride Capsules, USP Rx Only	Rising Pharma Holdings, Inc. \| Cohance Lifesciences Limited	2025-10-31	Human Prescription Drug Label	6