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 10 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	American Health Packaging	38af4e36-b26b-485d-a6f3-7fbcf6072a0f	2025-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	f0680426-3581-400c-8ab5-5e6f18d0cabc	2025-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	b4654497-c986-4792-9b6b-0a791c7c205b	2025-06-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	0e0ad9f1-1f52-48ce-a996-79ebe7ad53cd	2025-06-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	247f4d1d-6e65-4f81-a377-4dd88ae16dbb	2025-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	70dddaf0-f495-495f-95de-36e9efa2e373	2025-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	91afb351-f067-49a2-bdf0-336ea209718d	2025-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	237cc591-c40b-416f-ac00-96cd61bc59dc	2025-05-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	faaa1123-7515-46c2-abbb-b0615540c8cf	2025-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	7f8ec438-8ddf-45d2-be94-ac032e192229	2025-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	f5fc0f34-744c-4e03-ae9f-e017e4033139	2025-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	65b266af-72a5-4409-ab55-bd14341135aa	2025-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	9ff5ad8e-f28c-4322-be6e-072487878c12	2025-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals, Inc.	30ccec8b-3f95-61c7-e063-6394a90a05a0	2025-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Lupin Pharmaceuticals, Inc.	18717e58-89fb-4e2f-93b6-d6ac3e988d37	2025-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Fresenius Kabi USA, LLC	08f4b1f8-6807-47e7-bef8-8d1972aa0557	2025-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	f0a63075-631d-43bf-9d8e-df79faf0a278	2025-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals, Inc.	2cf48978-d996-f5ba-e063-6294a90a8824	2025-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	702016f6-8507-471f-b833-3a582aef5d2e	2025-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	RedPharm Drug, Inc	fcb196a2-31a6-437a-e053-6294a90a98ad	2025-01-23	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