Tralement

Product NDC: 0517-9305
11-digit product format: 005179305
Labeler code: 0517
Product ID: 0517-9305_4a6d8c5d-729c-45b3-b565-2e10e0cbcaaf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trace Elements Injection 4
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: American Regent, Inc.
Application: NDA209376
Marketing category: NDA
Marketing start: 2020-09-29
Substance: CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE
Active strength: .3; 55; 60; 3 mg/mL; ug/mL; ug/mL; mg/mL
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N209376-001	TRALEMENT	CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-07-02
N209376-002	TRALEMENT	CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-12-02
N209376-003	MULTRYS	CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE	EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-30

Orange Book patents#

Current patent rows page 1 of 1 · 15 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209376-001	11786548	2041-07-01		Drug product	2023-11-14
N209376-001	11975022	2041-07-01	U-3899		2024-05-08
N209376-001	11998565	2041-07-01		Drug product	2024-06-07
N209376-001	12150956	2041-07-01	U-3899		2024-12-03
N209376-001	12150957	2041-07-01	U-3899		2024-12-03
N209376-002	11786548	2041-07-01		Drug product	2023-11-14
N209376-002	11975022	2041-07-01	U-3899		2024-05-08
N209376-002	11998565	2041-07-01		Drug product	2024-06-07
N209376-002	12150956	2041-07-01	U-3899		2024-12-03
N209376-002	12150957	2041-07-01	U-3899		2024-12-03
N209376-003	11786548	2041-07-01		Drug product	2023-11-14
N209376-003	11975022	2041-07-01	U-3900		2024-05-08
N209376-003	11998565	2041-07-01		Drug product	2024-06-07
N209376-003	12150956	2041-07-01	U-3900		2024-12-03
N209376-003	12150957	2041-07-01	U-3900		2024-12-03

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 3 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209376-001	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209376-002	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209376-003	MULTRYS	EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209376-001	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209376-002	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209376-003	MULTRYS	EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209376-001	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209376-002	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209376-003	MULTRYS	EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209376-001	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209376-002	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209376-003	MULTRYS	EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209376-001	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209376-002	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209376-003	MULTRYS	EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209376-001	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209376-002	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209376-003	MULTRYS	EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209376-001	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209376-002	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-12-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209376-003	MULTRYS	EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209376-001	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209376-002	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-12-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209376-003	MULTRYS	EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209376-001	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209376-002	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-12-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209376-003	MULTRYS	EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209376-001	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209376-002	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-12-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209376-003	MULTRYS	EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209376-001	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209376-002	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-12-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209376-003	MULTRYS	EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209376-001	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209376-002	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-12-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209376-003	MULTRYS	EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209376-001	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209376-002	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-12-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209376-003	MULTRYS	EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209376-001	TRALEMENT	EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-07-02	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 204 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209376-001	11786548	2041-07-01		Drug product	2023-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209376-001	11975022	2041-07-01	U-3899		2024-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209376-001	11998565	2041-07-01		Drug product	2024-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209376-001	12150956	2041-07-01	U-3899		2024-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209376-001	12150957	2041-07-01	U-3899		2024-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209376-002	11786548	2041-07-01		Drug product	2023-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209376-002	11975022	2041-07-01	U-3899		2024-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209376-002	11998565	2041-07-01		Drug product	2024-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209376-002	12150956	2041-07-01	U-3899		2024-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209376-002	12150957	2041-07-01	U-3899		2024-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209376-003	11786548	2041-07-01		Drug product	2023-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209376-003	11975022	2041-07-01	U-3900		2024-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209376-003	11998565	2041-07-01		Drug product	2024-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209376-003	12150956	2041-07-01	U-3900		2024-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209376-003	12150957	2041-07-01	U-3900		2024-12-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209376-001	11786548	2041-07-01		Drug product	2023-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209376-001	11975022	2041-07-01	U-3899		2024-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209376-001	11998565	2041-07-01		Drug product	2024-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209376-001	12150956	2041-07-01	U-3899		2024-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209376-001	12150957	2041-07-01	U-3899		2024-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209376-002	11786548	2041-07-01		Drug product	2023-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209376-002	11975022	2041-07-01	U-3899		2024-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209376-002	11998565	2041-07-01		Drug product	2024-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209376-002	12150956	2041-07-01	U-3899		2024-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209376-002	12150957	2041-07-01	U-3899		2024-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209376-003	11786548	2041-07-01		Drug product	2023-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209376-003	11975022	2041-07-01	U-3900		2024-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209376-003	11998565	2041-07-01		Drug product	2024-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209376-003	12150956	2041-07-01	U-3900		2024-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209376-003	12150957	2041-07-01	U-3900		2024-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209376-001	11786548	2041-07-01		Drug product	2023-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209376-001	11975022	2041-07-01	U-3899		2024-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209376-001	11998565	2041-07-01		Drug product	2024-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209376-001	12150956	2041-07-01	U-3899		2024-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209376-001	12150957	2041-07-01	U-3899		2024-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209376-002	11786548	2041-07-01		Drug product	2023-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209376-002	11975022	2041-07-01	U-3899		2024-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209376-002	11998565	2041-07-01		Drug product	2024-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209376-002	12150956	2041-07-01	U-3899		2024-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209376-002	12150957	2041-07-01	U-3899		2024-12-03	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 85 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209376-001	NCE	2024-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209376-002	NCE	2024-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209376-003	NCE	2024-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209376-001	NCE	2024-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209376-002	NCE	2024-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209376-003	NCE	2024-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209376-001	NCE	2024-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209376-002	NCE	2024-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209376-003	NCE	2024-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209376-001	NCE	2024-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209376-002	NCE	2024-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209376-003	NCE	2024-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209376-001	NCE	2024-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209376-002	NCE	2024-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209376-003	NCE	2024-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209376-001	NCE	2024-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209376-002	NCE	2024-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209376-003	NCE	2024-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209376-001	NCE	2024-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209376-002	NCE	2024-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209376-003	NCE	2024-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209376-001	NCE	2024-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209376-002	NCE	2024-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209376-003	NCE	2024-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209376-001	NCE	2024-04-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209376-002	NCE	2024-04-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209376-003	NCE	2024-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209376-001	NCE	2024-04-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209376-002	NCE	2024-04-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209376-003	NCE	2024-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209376-001	NCE	2024-04-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209376-002	NCE	2024-04-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209376-003	NCE	2024-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209376-001	NCE	2024-04-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209376-002	NCE	2024-04-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209376-003	NCE	2024-04-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N209376-001	NCE	2024-04-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209376-002	NCE	2024-04-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209376-003	NCE	2024-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209376-001	NCE	2024-04-30	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tralement
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC SULFATE	.3 mg/mL
CUPRIC SULFATE	55 ug/mL
MANGANESE SULFATE	60 ug/mL
SELENIOUS ACID	3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
89DS0H96TB	Internal UNII lookup
LRX7AJ16DT	Internal UNII lookup
W00LYS4T26	Internal UNII lookup
F6A27P4Q4R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2693627	Internal RxNorm lookup
2693633	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
a49ffb90-f307-433e-a86e-aaea6d6a9982	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
86fffa7b-d382-4771-a253-25cccb64b590	Product name	3	20251124
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0517-9305-01	Tralement	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	1		9
0517-9305-25	Tralement	25 in 1 TRAY	INJECTION, SOLUTION	25		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0517-9305-01	ML - Milliliter	0517-9305	3de4f29a-338b-4d49-8360-66db78b2c0d1	1	2020-09-14
0517-9305-25	ML - Milliliter	0517-9305	70b87ef3-6a80-4277-a8df-ec4224a9be0a	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0517-9305	TRALEMENT (TRACE ELEMENTS INJECTION 4) INJECTION, SOLUTION [AMERICAN REGENT, INC.]	9	Current NDC, Legacy NDC, 2 package rows	20240824_a49ffb90-f307-433e-a86e-aaea6d6a9982.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
Multrys	TRACE ELEMENTS INJECTION 4	American Regent, Inc.	995f1efa-aca0-4b6c-9099-f8e757c2133a	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209376 application number: NDA209376
Tralement	TRACE ELEMENTS INJECTION 4	American Regent, Inc.	a49ffb90-f307-433e-a86e-aaea6d6a9982	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209376 application number: NDA209376 ndc (product): 0517-9305

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LRX7AJ16DT	CUPRIC SULFATE	7758-99-8	CUPRIC SULFATE
W00LYS4T26	MANGANESE SULFATE	10034-96-5	MANGANESE SULFATE
F6A27P4Q4R	SELENIOUS ACID	7783-00-8	SELENIOUS ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2693627	copper sulfate 0.75 MG (copper 0.3 MG) / manganese sulfate 151 MCG (manganese 55 MCG) / selenious acid 98 MCG (selenium 60 MCG) / zinc sulfate 7.41 MG (zinc 3 MG) in 1 ML Injection	PSN	a49ffb90-f307-433e-a86e-aaea6d6a9982	9
2693633	Tralement trace elements 4 in 1 ML Injection	PSN	a49ffb90-f307-433e-a86e-aaea6d6a9982	9
2693633	1 ML copper sulfate 0.75 MG/ML / manganese sulfate 0.151 MG/ML / selenious acid 0.098 MG/ML / zinc sulfate 7.41 MG/ML Injection [Tralement]	SBD	a49ffb90-f307-433e-a86e-aaea6d6a9982	9
2693627	1 ML copper sulfate 0.75 MG/ML / manganese sulfate 0.151 MG/ML / selenious acid 0.098 MG/ML / zinc sulfate 7.41 MG/ML Injection	SCD	a49ffb90-f307-433e-a86e-aaea6d6a9982	9
2693627	1 ML copper sulfate 0.75 MG/ML / manganese sulfate 0.151 MG/ML / selenious acid 0.098 MG/ML / ZnSO4 7.41 MG/ML Injection	SY	a49ffb90-f307-433e-a86e-aaea6d6a9982	9
2693633	1 ML copper sulfate 0.75 MG/ML / manganese sulfate 0.151 MG/ML / selenious acid 0.098 MG/ML / ZnSO4 7.41 MG/ML Injection [Tralement]	SY	a49ffb90-f307-433e-a86e-aaea6d6a9982	9
2693627	copper sulfate 0.75 MG (copper 0.3 MG) / manganese sulfate 151 MCG (manganese 55 MCG) / selenious acid 98 MCG (selenium 60 MCG) / zinc sulfate 7.41 MG (zinc 3 MG) per 1 ML Injection	SY	a49ffb90-f307-433e-a86e-aaea6d6a9982	9
2693633	Tralement (copper sulfate 0.75 MG (copper 0.3 MG) / manganese sulfate 151 MCG (manganese 55 MCG) / selenious acid 98 MCG (selenium 60 MCG) / zinc sulfate 7.41 MG (zinc 3 MG)) per 1 ML Injection	SY	a49ffb90-f307-433e-a86e-aaea6d6a9982	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0517-9305-01	00517930501	1 mL in 1 VIAL, SINGLE-DOSE	1 ml					Historical
0517-9305-25	00517930525	25 VIAL, SINGLE-DOSE in 1 TRAY (0517-9305-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-9305-01)		2020-09-29	0000-00-00	No	No	Current