Trientine hydrochloride

Product NDC: 69539-078
11-digit product format: 695390078
Labeler code: 69539
Product ID: 69539-078_8908d8af-fa31-4711-a33c-f4b7fbf7d31f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trientine hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: MSN LABORATORIES PRIVATE LIMITED
Application: ANDA211134
Marketing category: ANDA
Marketing start: 2019-05-22
Marketing end: 0000-00-00
Substance: TRIENTINE HYDROCHLORIDE
Active strength: 250 mg/1
Pharmacologic classes: Metal Chelating Activity [MoA],Metal Chelator [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	69539-078		D	Discontinued by firm		2026-08-17
excluded package	package	69539-078	69539-078-91	D	Discontinued by firm		2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	69539-078		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69539-078	69539-078-91	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
A211134-001	TRIENTINE HYDROCHLORIDE	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2019-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211134-001	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 · 42 observed 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	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	BX	2019-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	BX	2019-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	BX	2019-05-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	BX	2019-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	BX	2019-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2019-05-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	BX	2019-05-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	BX	2019-05-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	BX	2019-05-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211134-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	BX	2019-05-22	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211134-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211134-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211134-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211134-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211134-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211134-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211134-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211134-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211134-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211134-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211134-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211134-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211134-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211134-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211134-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211134-001	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211134-001	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211134-001	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211134-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211134-001	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211134-001	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211134-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211134-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211134-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211134-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211134-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211134-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211134-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211134-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211134-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211134-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211134-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211134-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211134-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211134-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211134-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211134-001	BX	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211134-001	BX	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211134-001	BX	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211134-001	BX	1	`e64feba35796…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69539-078	TRIENTINE HYDROCHLORIDE CAPSULE [MSN LABORATORIES PRIVATE LIMITED]	3	Legacy NDC	20190529_a06303b2-ac18-41bf-82c3-881cf7ecefb2.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	Novadoz Pharmaceuticals LLC	6bc468ca-07ef-4965-b502-0330b76455a0	2022-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211134 application number: ANDA211134

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69539-078-91	69539007891	1 BOTTLE in 1 CARTON (69539-078-91) > 100 CAPSULE in 1 BOTTLE	1 bottle	2019-05-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trientine hydrochloride Capsules USP 250 mg	MSN LABORATORIES PRIVATE LIMITED	2019-05-27	Human Prescription Drug Label	3