Application 021137

Type: NDA
Sponsor: GENUS LIFESCIENCES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOLET	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.025MG	No	No
002	LEVOLET	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.05MG	No	No
003	LEVOLET	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.075MG	No	No
004	LEVOLET	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.088MG	No	No
005	LEVOLET	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.1MG	No	No
006	LEVOLET	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.112MG	No	No
007	LEVOLET	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.125MG	No	No
008	LEVOLET	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.137MG	No	No
009	LEVOLET	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.15MG	No	No
010	LEVOLET	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.175MG	No	No
011	LEVOLET	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.2MG	No	No
012	LEVOLET	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.3MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
N021137-001	LEVOLET	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06
N021137-002	LEVOLET	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06
N021137-003	LEVOLET	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06
N021137-004	LEVOLET	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06
N021137-005	LEVOLET	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06
N021137-006	LEVOLET	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06
N021137-007	LEVOLET	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06
N021137-008	LEVOLET	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06
N021137-009	LEVOLET	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06
N021137-010	LEVOLET	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06
N021137-011	LEVOLET	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06
N021137-012	LEVOLET	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 48 matching rows.

Application-product, TE code table
Application-product	TE code
N021137-001	AB1
N021137-001	AB2
N021137-001	AB3
N021137-001	AB4
N021137-002	AB1
N021137-002	AB2
N021137-002	AB3
N021137-002	AB4
N021137-003	AB1
N021137-003	AB2
N021137-003	AB3
N021137-003	AB4
N021137-004	AB1
N021137-004	AB2
N021137-004	AB3
N021137-004	AB4
N021137-005	AB1
N021137-005	AB2
N021137-005	AB3
N021137-005	AB4
N021137-006	AB1
N021137-006	AB2
N021137-006	AB3
N021137-006	AB4
N021137-007	AB1
N021137-007	AB2
N021137-007	AB3
N021137-007	AB4
N021137-008	AB1
N021137-008	AB2
N021137-008	AB3
N021137-008	AB4
N021137-009	AB1
N021137-009	AB2
N021137-009	AB3
N021137-009	AB4
N021137-010	AB1
N021137-010	AB2
N021137-010	AB3
N021137-010	AB4
N021137-011	AB1
N021137-011	AB2
N021137-011	AB3
N021137-011	AB4
N021137-012	AB1
N021137-012	AB2
N021137-012	AB3
N021137-012	AB4

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N021137-003	10231931	2038-03-23	Drug product	2022-01-07
N021137-003	10406108	2038-03-23	Drug product	2022-01-07
N021137-004	10231931	2038-03-23	Drug product	2022-01-07
N021137-004	10406108	2038-03-23	Drug product	2022-01-07
N021137-005	10231931	2038-03-23	Drug product	2022-01-07
N021137-005	10406108	2038-03-23	Drug product	2022-01-07
N021137-006	10231931	2038-03-23	Drug product	2022-01-07
N021137-006	10406108	2038-03-23	Drug product	2022-01-07
N021137-007	10231931	2038-03-23	Drug product	2022-01-07
N021137-007	10406108	2038-03-23	Drug product	2022-01-07
N021137-008	10231931	2038-03-23	Drug product	2022-01-07
N021137-008	10406108	2038-03-23	Drug product	2022-01-07
N021137-009	10231931	2038-03-23	Drug product	2022-01-07
N021137-009	10406108	2038-03-23	Drug product	2022-01-07
N021137-010	10231931	2038-03-23	Drug product	2022-01-07
N021137-010	10406108	2038-03-23	Drug product	2022-01-07
N021137-011	10231931	2038-03-23	Drug product	2022-01-07
N021137-011	10406108	2038-03-23	Drug product	2022-01-07
N021137-012	10231931	2038-03-23	Drug product	2022-01-07
N021137-012	10406108	2038-03-23	Drug product	2022-01-07

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 13 · 516 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
2026-09-14 22:38:34	2026-08	N021137-001	LEVOLET	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-002	LEVOLET	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-003	LEVOLET	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-004	LEVOLET	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-005	LEVOLET	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-006	LEVOLET	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-007	LEVOLET	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-008	LEVOLET	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-009	LEVOLET	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-010	LEVOLET	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-011	LEVOLET	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-012	LEVOLET	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021137-001	LEVOLET	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-002	LEVOLET	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-003	LEVOLET	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-004	LEVOLET	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-005	LEVOLET	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-006	LEVOLET	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-007	LEVOLET	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-008	LEVOLET	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-009	LEVOLET	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-010	LEVOLET	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-011	LEVOLET	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-012	LEVOLET	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021137-001	LEVOLET	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021137-002	LEVOLET	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021137-003	LEVOLET	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021137-004	LEVOLET	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021137-005	LEVOLET	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021137-006	LEVOLET	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021137-007	LEVOLET	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021137-008	LEVOLET	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021137-009	LEVOLET	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021137-010	LEVOLET	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021137-011	LEVOLET	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021137-012	LEVOLET	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021137-001	LEVOLET	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021137-002	LEVOLET	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021137-003	LEVOLET	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021137-004	LEVOLET	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2003-06-06	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 40 · 1,572 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N021137-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-001	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-001	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-001	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-002	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-002	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-002	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-003	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-003	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-003	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-004	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-004	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-004	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-004	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-005	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-005	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-005	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-005	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-006	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-006	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-006	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-006	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-007	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-007	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-007	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-007	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-008	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-008	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-008	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-008	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-009	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-009	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-009	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-009	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-010	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-010	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-010	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-010	AB4	4	`84e616aacf4f…`

Observed Orange Book patent history#

Patent history page 1 of 17 · 680 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021137-003	10231931	2038-03-23	Drug product	2022-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-003	10406108	2038-03-23	Drug product	2022-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-004	10231931	2038-03-23	Drug product	2022-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-004	10406108	2038-03-23	Drug product	2022-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-005	10231931	2038-03-23	Drug product	2022-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-005	10406108	2038-03-23	Drug product	2022-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-006	10231931	2038-03-23	Drug product	2022-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-006	10406108	2038-03-23	Drug product	2022-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-007	10231931	2038-03-23	Drug product	2022-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-007	10406108	2038-03-23	Drug product	2022-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-008	10231931	2038-03-23	Drug product	2022-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-008	10406108	2038-03-23	Drug product	2022-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-009	10231931	2038-03-23	Drug product	2022-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-009	10406108	2038-03-23	Drug product	2022-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-010	10231931	2038-03-23	Drug product	2022-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-010	10406108	2038-03-23	Drug product	2022-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-011	10231931	2038-03-23	Drug product	2022-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-011	10406108	2038-03-23	Drug product	2022-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-012	10231931	2038-03-23	Drug product	2022-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021137-012	10406108	2038-03-23	Drug product	2022-01-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021137-003	10231931	2038-03-23	Drug product	2022-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-003	10406108	2038-03-23	Drug product	2022-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-004	10231931	2038-03-23	Drug product	2022-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-004	10406108	2038-03-23	Drug product	2022-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-005	10231931	2038-03-23	Drug product	2022-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-005	10406108	2038-03-23	Drug product	2022-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-006	10231931	2038-03-23	Drug product	2022-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-006	10406108	2038-03-23	Drug product	2022-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-007	10231931	2038-03-23	Drug product	2022-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-007	10406108	2038-03-23	Drug product	2022-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-008	10231931	2038-03-23	Drug product	2022-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-008	10406108	2038-03-23	Drug product	2022-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-009	10231931	2038-03-23	Drug product	2022-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-009	10406108	2038-03-23	Drug product	2022-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-010	10231931	2038-03-23	Drug product	2022-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-010	10406108	2038-03-23	Drug product	2022-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-011	10231931	2038-03-23	Drug product	2022-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-011	10406108	2038-03-23	Drug product	2022-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-012	10231931	2038-03-23	Drug product	2022-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021137-012	10406108	2038-03-23	Drug product	2022-01-07	`caaa826d4ba7…`

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 4 of 14 · 274 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	caf7825d-f434-472f-94f3-217a41255562	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	55cebc88-0514-4940-b974-ec7f0467d10e	2026-04-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	c7d5b71b-e983-4b1a-bfc2-d2343cf8668c	2026-04-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	0235176b-ec39-44c4-a9e1-e0729a7989fa	2026-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	7d07e932-7372-4c17-aa53-55087107fa52	2026-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	73c3d459-dcbf-4458-8edd-2637275a96a1	2026-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	2ecaa38f-8a6f-4536-8033-251d2c52ae64	2026-03-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	4461bc9f-35db-4211-82ab-7671cf4dc14b	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	66bb0ba9-cd63-4817-907f-7b8ad5dc6685	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Tirosint SOL	LEVOTHYROXINE SODIUM	IBSA Pharma Inc.	5d378add-f13d-40f2-99dc-0f2340ab44b7	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	a0fa8fa5-d3bd-4e52-9ec5-5fb84702826d	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	70853a82-ba3b-4663-9f78-6791ca72ba9f	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	8ac112c3-1e06-4fdb-a7af-2ee988de5b15	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	69fb5cd6-90ba-487d-a754-07c664a1fdd1	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Tirosint	LEVOTHYROXINE SODIUM	IBSA Pharma Inc.	7a7ade79-0165-4e31-b84e-667416c00c7e	2026-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	YARAL Pharma Inc.	d28d7202-1278-0486-e053-2995a90af286	2026-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	7c8a6441-3c12-46ae-bb3b-a320d80045b6	2026-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	008de8fd-150f-4022-8ccb-c8bfa94875c7	2026-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	991399a4-ff94-44d0-b1ba-1f89e7759498	2026-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	87333260-fe57-4d99-886c-7c66cb063898	2026-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71742	SUPPL	2022-08-08
69712	SUPPL	2021-12-21
69711	SUPPL	2021-12-21
69710	SUPPL	2021-12-21
69632	SUPPL	2021-12-19
69631	SUPPL	2021-12-19
69630	SUPPL	2021-12-19
14481	ORIG	2004-06-08
41978	ORIG	2004-06-04
26884	ORIG	2003-06-08