Tirosint

Product NDC: 71858-0125
11-digit product format: 718580125
Labeler code: 71858
Product ID: 71858-0125_4e04737b-8d88-7c75-e063-6394a90a34c0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levothyroxine Sodium
Dosage form: SOLUTION
Route: ORAL
Labeler: IBSA Pharma Inc.
Application: NDA206977
Marketing category: NDA
Marketing start: 2019-03-01
Substance: LEVOTHYROXINE SODIUM
Active strength: 88 ug/mL
Pharmacologic classes: Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71858-0125	71858-0125-1	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N206977-001	TIROSINT-SOL	LEVOTHYROXINE SODIUM	13MCG/ML	SOLUTION / ORAL	RLD	2016-12-15
N206977-002	TIROSINT-SOL	LEVOTHYROXINE SODIUM	25MCG/ML	SOLUTION / ORAL	RLD	2016-12-15
N206977-003	TIROSINT-SOL	LEVOTHYROXINE SODIUM	50MCG/ML	SOLUTION / ORAL	RLD	2016-12-15
N206977-004	TIROSINT-SOL	LEVOTHYROXINE SODIUM	75MCG/ML	SOLUTION / ORAL	RLD	2016-12-15
N206977-005	TIROSINT-SOL	LEVOTHYROXINE SODIUM	88MCG/ML	SOLUTION / ORAL	RLD	2016-12-15
N206977-006	TIROSINT-SOL	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / ORAL	RLD	2016-12-15
N206977-007	TIROSINT-SOL	LEVOTHYROXINE SODIUM	112MCG/ML	SOLUTION / ORAL	RLD	2016-12-15
N206977-008	TIROSINT-SOL	LEVOTHYROXINE SODIUM	125MCG/ML	SOLUTION / ORAL	RLD	2016-12-15
N206977-009	TIROSINT-SOL	LEVOTHYROXINE SODIUM	137MCG/ML	SOLUTION / ORAL	RLD	2016-12-15
N206977-010	TIROSINT-SOL	LEVOTHYROXINE SODIUM	150MCG/ML	SOLUTION / ORAL	RLD	2016-12-15
N206977-011	TIROSINT-SOL	LEVOTHYROXINE SODIUM	175MCG/ML	SOLUTION / ORAL	RLD	2016-12-15
N206977-012	TIROSINT-SOL	LEVOTHYROXINE SODIUM	200MCG/ML	SOLUTION / ORAL	RLD, RS	2016-12-15
N206977-013	TIROSINT-SOL	LEVOTHYROXINE SODIUM	37.5MCG/ML	SOLUTION / ORAL	RLD	2021-01-13
N206977-014	TIROSINT-SOL	LEVOTHYROXINE SODIUM	44MCG/ML	SOLUTION / ORAL	RLD	2021-01-13
N206977-015	TIROSINT-SOL	LEVOTHYROXINE SODIUM	62.5MCG/ML	SOLUTION / ORAL	RLD	2021-01-13

Orange Book patents#

Current patent rows page 1 of 1 · 75 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206977-001	10537538	2037-02-28		Drug product	2020-02-19
N206977-001	11096913	2037-02-28		Drug product	2021-09-20
N206977-001	11241382	2039-09-17	U-3757		2023-12-14
N206977-001	11241382	2039-09-17	U-3758		2023-12-14
N206977-001	12564565	2044-09-26		Drug product	2026-03-20
N206977-002	10537538	2037-02-28		Drug product	2020-02-19
N206977-002	11096913	2037-02-28		Drug product	2021-09-20
N206977-002	11241382	2039-09-17	U-3757		2023-12-14
N206977-002	11241382	2039-09-17	U-3758		2023-12-14
N206977-002	12564565	2044-09-26		Drug product	2026-03-20
N206977-003	10537538	2037-02-28		Drug product	2020-02-19
N206977-003	11096913	2037-02-28		Drug product	2021-09-20
N206977-003	11241382	2039-09-17	U-3757		2023-12-14
N206977-003	11241382	2039-09-17	U-3758		2023-12-14
N206977-003	12564565	2044-09-26		Drug product	2026-03-20
N206977-004	10537538	2037-02-28		Drug product	2020-02-19
N206977-004	11096913	2037-02-28		Drug product	2021-09-20
N206977-004	11241382	2039-09-17	U-3757		2023-12-14
N206977-004	11241382	2039-09-17	U-3758		2023-12-14
N206977-004	12564565	2044-09-26		Drug product	2026-03-20
N206977-005	10537538	2037-02-28		Drug product	2020-02-19
N206977-005	11096913	2037-02-28		Drug product	2021-09-20
N206977-005	11241382	2039-09-17	U-3757		2023-12-14
N206977-005	11241382	2039-09-17	U-3758		2023-12-14
N206977-005	12564565	2044-09-26		Drug product	2026-03-20
N206977-006	10537538	2037-02-28		Drug product	2020-02-19
N206977-006	11096913	2037-02-28		Drug product	2021-09-20
N206977-006	11241382	2039-09-17	U-3757		2023-12-14
N206977-006	11241382	2039-09-17	U-3758		2023-12-14
N206977-006	12564565	2044-09-26		Drug product	2026-03-20
N206977-007	10537538	2037-02-28		Drug product	2020-02-19
N206977-007	11096913	2037-02-28		Drug product	2021-09-20
N206977-007	11241382	2039-09-17	U-3757		2023-12-14
N206977-007	11241382	2039-09-17	U-3758		2023-12-14
N206977-007	12564565	2044-09-26		Drug product	2026-03-20
N206977-008	10537538	2037-02-28		Drug product	2020-02-19
N206977-008	11096913	2037-02-28		Drug product	2021-09-20
N206977-008	11241382	2039-09-17	U-3757		2023-12-14
N206977-008	11241382	2039-09-17	U-3758		2023-12-14
N206977-008	12564565	2044-09-26		Drug product	2026-03-20
N206977-009	10537538	2037-02-28		Drug product	2020-02-19
N206977-009	11096913	2037-02-28		Drug product	2021-09-20
N206977-009	11241382	2039-09-17	U-3757		2023-12-14
N206977-009	11241382	2039-09-17	U-3758		2023-12-14
N206977-009	12564565	2044-09-26		Drug product	2026-03-20
N206977-010	10537538	2037-02-28		Drug product	2020-02-19
N206977-010	11096913	2037-02-28		Drug product	2021-09-20
N206977-010	11241382	2039-09-17	U-3757		2023-12-14
N206977-010	11241382	2039-09-17	U-3758		2023-12-14
N206977-010	12564565	2044-09-26		Drug product	2026-03-20
N206977-011	10537538	2037-02-28		Drug product	2020-02-19
N206977-011	11096913	2037-02-28		Drug product	2021-09-20
N206977-011	11241382	2039-09-17	U-3757		2023-12-14
N206977-011	11241382	2039-09-17	U-3758		2023-12-14
N206977-011	12564565	2044-09-26		Drug product	2026-03-20
N206977-012	10537538	2037-02-28		Drug product	2020-02-19
N206977-012	11096913	2037-02-28		Drug product	2021-09-20
N206977-012	11241382	2039-09-17	U-3757		2023-12-14
N206977-012	11241382	2039-09-17	U-3758		2023-12-14
N206977-012	12564565	2044-09-26		Drug product	2026-03-20
N206977-013	10537538	2037-02-28		Drug product	2022-04-20
N206977-013	11096913	2037-02-28		Drug product	2021-09-20
N206977-013	11241382	2039-09-17	U-3757		2023-12-14
N206977-013	11241382	2039-09-17	U-3758		2023-12-14
N206977-013	12564565	2044-09-26		Drug product	2026-03-20
N206977-014	10537538	2037-02-28		Drug product	2022-04-20
N206977-014	11096913	2037-02-28		Drug product	2021-09-20
N206977-014	11241382	2039-09-17	U-3757		2023-12-14
N206977-014	11241382	2039-09-17	U-3758		2023-12-14
N206977-014	12564565	2044-09-26		Drug product	2026-03-20
N206977-015	10537538	2037-02-28		Drug product	2022-04-20
N206977-015	11096913	2037-02-28		Drug product	2021-09-20
N206977-015	11241382	2039-09-17	U-3757		2023-12-14
N206977-015	11241382	2039-09-17	U-3758		2023-12-14
N206977-015	12564565	2044-09-26		Drug product	2026-03-20

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 15 · 597 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	N206977-001	TIROSINT-SOL	13MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-002	TIROSINT-SOL	25MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-003	TIROSINT-SOL	50MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-004	TIROSINT-SOL	75MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-005	TIROSINT-SOL	88MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-006	TIROSINT-SOL	100MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-007	TIROSINT-SOL	112MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-008	TIROSINT-SOL	125MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-009	TIROSINT-SOL	137MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-010	TIROSINT-SOL	150MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-011	TIROSINT-SOL	175MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-012	TIROSINT-SOL	200MCG/ML	SOLUTION / ORAL	RLD, RS	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-013	TIROSINT-SOL	37.5MCG/ML	SOLUTION / ORAL	RLD	2021-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-014	TIROSINT-SOL	44MCG/ML	SOLUTION / ORAL	RLD	2021-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-015	TIROSINT-SOL	62.5MCG/ML	SOLUTION / ORAL	RLD	2021-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-001	TIROSINT-SOL	13MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-002	TIROSINT-SOL	25MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-003	TIROSINT-SOL	50MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-004	TIROSINT-SOL	75MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-005	TIROSINT-SOL	88MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-006	TIROSINT-SOL	100MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-007	TIROSINT-SOL	112MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-008	TIROSINT-SOL	125MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-009	TIROSINT-SOL	137MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-010	TIROSINT-SOL	150MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-011	TIROSINT-SOL	175MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-012	TIROSINT-SOL	200MCG/ML	SOLUTION / ORAL	RLD, RS	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-013	TIROSINT-SOL	37.5MCG/ML	SOLUTION / ORAL	RLD	2021-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-014	TIROSINT-SOL	44MCG/ML	SOLUTION / ORAL	RLD	2021-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-015	TIROSINT-SOL	62.5MCG/ML	SOLUTION / ORAL	RLD	2021-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206977-001	TIROSINT-SOL	13MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206977-002	TIROSINT-SOL	25MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206977-003	TIROSINT-SOL	50MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206977-004	TIROSINT-SOL	75MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206977-005	TIROSINT-SOL	88MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206977-006	TIROSINT-SOL	100MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206977-007	TIROSINT-SOL	112MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206977-008	TIROSINT-SOL	125MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206977-009	TIROSINT-SOL	137MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206977-010	TIROSINT-SOL	150MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`6a471c1ec25d…`

Observed Orange Book patent history#

Patent history page 1 of 39 · 1,551 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206977-001	10537538	2037-02-28		Drug product	2020-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-001	11096913	2037-02-28		Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-001	11241382	2039-09-17	U-3757		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-001	11241382	2039-09-17	U-3758		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-002	10537538	2037-02-28		Drug product	2020-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-002	11096913	2037-02-28		Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-002	11241382	2039-09-17	U-3758		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-002	11241382	2039-09-17	U-3757		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-003	10537538	2037-02-28		Drug product	2020-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-003	11096913	2037-02-28		Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-003	11241382	2039-09-17	U-3758		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-003	11241382	2039-09-17	U-3757		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-004	10537538	2037-02-28		Drug product	2020-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-004	11096913	2037-02-28		Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-004	11241382	2039-09-17	U-3758		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-004	11241382	2039-09-17	U-3757		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-005	10537538	2037-02-28		Drug product	2020-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-005	11096913	2037-02-28		Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-005	11241382	2039-09-17	U-3758		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-005	11241382	2039-09-17	U-3757		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-006	10537538	2037-02-28		Drug product	2020-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-006	11096913	2037-02-28		Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-006	11241382	2039-09-17	U-3758		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-006	11241382	2039-09-17	U-3757		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-007	10537538	2037-02-28		Drug product	2020-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-007	11096913	2037-02-28		Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-007	11241382	2039-09-17	U-3758		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-007	11241382	2039-09-17	U-3757		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-008	10537538	2037-02-28		Drug product	2020-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-008	11096913	2037-02-28		Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-008	11241382	2039-09-17	U-3758		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-008	11241382	2039-09-17	U-3757		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-009	10537538	2037-02-28		Drug product	2020-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-009	11096913	2037-02-28		Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-009	11241382	2039-09-17	U-3758		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-009	11241382	2039-09-17	U-3757		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-010	10537538	2037-02-28		Drug product	2020-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-010	11096913	2037-02-28		Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-010	11241382	2039-09-17	U-3758		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-010	11241382	2039-09-17	U-3757		2023-12-14	`011fe1cb6892…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tirosint
Brand name suffix: SOL
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVOTHYROXINE SODIUM	88 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9J765S329G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 2 · 30 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2056462	Internal RxNorm lookup
2056466	Internal RxNorm lookup
2056468	Internal RxNorm lookup
2056470	Internal RxNorm lookup
2056472	Internal RxNorm lookup
2056474	Internal RxNorm lookup
2056476	Internal RxNorm lookup
2056478	Internal RxNorm lookup
2056480	Internal RxNorm lookup
2056482	Internal RxNorm lookup
2056484	Internal RxNorm lookup
2056486	Internal RxNorm lookup
2056488	Internal RxNorm lookup
2056490	Internal RxNorm lookup
2056492	Internal RxNorm lookup
2056494	Internal RxNorm lookup
2056496	Internal RxNorm lookup
2056498	Internal RxNorm lookup
2056500	Internal RxNorm lookup
2056502	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
5d378add-f13d-40f2-99dc-0f2340ab44b7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
97c252d3-9bb8-4530-bb44-9824dc7cf556	Product name	6	20250729
6c43b71c-35e6-4db3-ba24-c6ef42ff7003	Product name	3	20240207
890fd4bf-1a80-42b7-be1b-2d0259d5f0c8	Product name	5	20240207
c8ad26bf-af73-460b-b74e-1eff16cc4f9f	Product name	5	20240207
01383843-4069-43cf-aa76-dc17a6f9f8c4	Product name	2	20230123
978cca7d-a938-4791-8322-da48d90a63ef	Product name	1	20230113
65f86ba3-8816-4e12-899b-18290c8de551	Product name	2	20210614
f16ab90f-08c2-40be-a543-66d9827cd1f3	Product name	1	20210601
6a33ec05-2ae2-45e5-ab82-2d94b3303923	Product name	1	20190709
93355a10-1c44-4c92-a11d-7d995e0200d9	Product name	1	20190219

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71858-0125-1	TirosintSOL	2 in 1 CARTON	SOLUTION	2	18
71858-0125-2	TirosintSOL	6 in 1 CARTON	SOLUTION	6	18
71858-0125-4	TirosintSOL	5 in 1 POUCH	SOLUTION	5	18
71858-0125-5	TirosintSOL	6 in 1 CARTON	SOLUTION	6	18
71858-0125-6	TirosintSOL	1 mL in 1 AMPULE	SOLUTION	1	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71858-0125-4	ML - Milliliter	71858-0125	34941a69-5a95-4a0f-96ac-2958792bce26	1	2019-03-12
71858-0125-5	ML - Milliliter	71858-0125	3eb30d02-8352-4fcc-b504-7d81674f2aa2	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71858-0125	TIROSINT SOL (LEVOTHYROXINE SODIUM) SOLUTION [IBSA PHARMA INC.]	16	Current NDC, Legacy NDC, 5 package rows	20241025_5d378add-f13d-40f2-99dc-0f2340ab44b7.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
Tirosint SOL	LEVOTHYROXINE SODIUM	IBSA Pharma Inc.	5d378add-f13d-40f2-99dc-0f2340ab44b7	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 206977 application number: NDA206977 ndc (product): 71858-0125

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9J765S329G	LEVOTHYROXINE SODIUM	6106-07-6	LEVOTHYROXINE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2056480	levothyroxine sodium 100 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056484	levothyroxine sodium 112 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056488	levothyroxine sodium 125 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056492	levothyroxine sodium 13 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056496	levothyroxine sodium 137 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056500	levothyroxine sodium 150 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056504	levothyroxine sodium 175 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056508	levothyroxine sodium 200 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056462	levothyroxine sodium 25 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2566613	levothyroxine sodium 37.5 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2566617	levothyroxine sodium 44 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056468	levothyroxine sodium 50 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2566608	levothyroxine sodium 62.5 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056472	levothyroxine sodium 75 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056476	levothyroxine sodium 88 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056482	TIROSINT - SOL 100 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056486	TIROSINT - SOL 112 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056490	TIROSINT - SOL 125 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056494	TIROSINT - SOL 13 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056498	TIROSINT - SOL 137 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056502	TIROSINT - SOL 150 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056506	TIROSINT - SOL 175 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056510	TIROSINT - SOL 200 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056466	TIROSINT - SOL 25 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2566615	TIROSINT - SOL 37.5 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2566619	TIROSINT - SOL 44 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056470	TIROSINT - SOL 50 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2566610	TIROSINT - SOL 62.5 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056474	TIROSINT - SOL 75 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056478	TIROSINT - SOL 88 MCG in 1 mL Oral Solution	PSN	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056494	levothyroxine sodium 0.013 MG/ML Oral Solution [Tirosint]	SBD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056466	levothyroxine sodium 0.025 MG/ML Oral Solution [Tirosint]	SBD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2566615	levothyroxine sodium 0.0375 MG/ML Oral Solution [Tirosint]	SBD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2566619	levothyroxine sodium 0.044 MG/ML Oral Solution [Tirosint]	SBD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056470	levothyroxine sodium 0.05 MG/ML Oral Solution [Tirosint]	SBD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2566610	levothyroxine sodium 0.0625 MG/ML Oral Solution [Tirosint]	SBD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056474	levothyroxine sodium 0.075 MG/ML Oral Solution [Tirosint]	SBD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056478	levothyroxine sodium 0.088 MG/ML Oral Solution [Tirosint]	SBD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056482	levothyroxine sodium 0.1 MG/ML Oral Solution [Tirosint]	SBD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056486	levothyroxine sodium 0.112 MG/ML Oral Solution [Tirosint]	SBD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056490	levothyroxine sodium 0.125 MG/ML Oral Solution [Tirosint]	SBD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056498	levothyroxine sodium 0.137 MG/ML Oral Solution [Tirosint]	SBD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056502	levothyroxine sodium 0.15 MG/ML Oral Solution [Tirosint]	SBD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056506	levothyroxine sodium 0.175 MG/ML Oral Solution [Tirosint]	SBD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056510	levothyroxine sodium 0.2 MG/ML Oral Solution [Tirosint]	SBD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056492	levothyroxine sodium 0.013 MG/ML Oral Solution	SCD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056462	levothyroxine sodium 0.025 MG/ML Oral Solution	SCD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2566613	levothyroxine sodium 0.0375 MG/ML Oral Solution	SCD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2566617	levothyroxine sodium 0.044 MG/ML Oral Solution	SCD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056468	levothyroxine sodium 0.05 MG/ML Oral Solution	SCD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2566608	levothyroxine sodium 0.0625 MG/ML Oral Solution	SCD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056472	levothyroxine sodium 0.075 MG/ML Oral Solution	SCD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056476	levothyroxine sodium 0.088 MG/ML Oral Solution	SCD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056480	levothyroxine sodium 0.1 MG/ML Oral Solution	SCD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056484	levothyroxine sodium 0.112 MG/ML Oral Solution	SCD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056488	levothyroxine sodium 0.125 MG/ML Oral Solution	SCD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056496	levothyroxine sodium 0.137 MG/ML Oral Solution	SCD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056500	levothyroxine sodium 0.15 MG/ML Oral Solution	SCD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056504	levothyroxine sodium 0.175 MG/ML Oral Solution	SCD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056508	levothyroxine sodium 0.2 MG/ML Oral Solution	SCD	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056480	levothyroxine sodium 100 MCG per 1 ML Oral Solution	SY	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056484	levothyroxine sodium 112 MCG per 1 ML Oral Solution	SY	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056488	levothyroxine sodium 125 MCG per 1 ML Oral Solution	SY	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056492	levothyroxine sodium 13 MCG per 1 ML Oral Solution	SY	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056496	levothyroxine sodium 137 MCG per 1 ML Oral Solution	SY	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056504	levothyroxine sodium 175 MCG per 1 ML Oral Solution	SY	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056508	levothyroxine sodium 200 MCG per 1 ML Oral Solution	SY	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056462	levothyroxine sodium 25 MCG per 1 ML Oral Solution	SY	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056468	levothyroxine sodium 50 MCG per 1 ML Oral Solution	SY	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056472	levothyroxine sodium 75 MCG per 1 ML Oral Solution	SY	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056476	levothyroxine sodium 88 MCG per 1 ML Oral Solution	SY	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2566615	Tirosint 0.0375 MG/ML Oral Solution	SY	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2566619	Tirosint 0.044 MG/ML Oral Solution	SY	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2566610	Tirosint 0.0625 MG/ML Oral Solution	SY	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056494	Tirosint SOL 0.013 MG per 1 ML Oral Solution	SY	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056466	Tirosint SOL 0.025 MG per 1 ML Oral Solution	SY	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056470	Tirosint SOL 0.05 MG per 1 ML Oral Solution	SY	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056474	Tirosint SOL 0.075 MG per 1 ML Oral Solution	SY	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056478	Tirosint SOL 0.088 MG per 1 ML Oral Solution	SY	5d378add-f13d-40f2-99dc-0f2340ab44b7	18
2056482	Tirosint SOL 0.1 MG per 1 ML Oral Solution	SY	5d378add-f13d-40f2-99dc-0f2340ab44b7	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71858-0125-1	71858012501	2 POUCH in 1 CARTON (71858-0125-1) > 5 AMPULE in 1 POUCH (71858-0125-4) > 1 mL in 1 AMPULE	2 pouch	2019-03-01	0000-00-00	No	No	Current
71858-0125-2	71858012502	6 POUCH in 1 CARTON (71858-0125-2) / 5 AMPULE in 1 POUCH (71858-0125-4) / 1 mL in 1 AMPULE (71858-0125-6)	6 pouch	2025-07-25		Yes	No	Current
71858-0125-4	71858012504	5 in 1 POUCH						Historical
71858-0125-5	71858012505	6 POUCH in 1 CARTON (71858-0125-5) / 5 AMPULE in 1 POUCH (71858-0125-4) / 1 mL in 1 AMPULE (71858-0125-6)	6 pouch	2019-03-01	0000-00-00	No	No	Current
71858-0125-6	71858012506	1 mL in 1 AMPULE	1 ml					Historical