Application 076187

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
004	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
005	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
006	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
007	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
008	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
009	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
010	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
011	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	Yes
012	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	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	RLD / RS	Approval date
A076187-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-004	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-005	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-006	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-007	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-008	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-009	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-010	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-011	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	RS	2002-06-05
A076187-012	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2006-12-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076187-001	AB1
A076187-001	AB2
A076187-001	AB3
A076187-001	AB4
A076187-002	AB1
A076187-002	AB2
A076187-002	AB3
A076187-002	AB4
A076187-003	AB1
A076187-003	AB2
A076187-003	AB3
A076187-003	AB4
A076187-004	AB1
A076187-004	AB2
A076187-004	AB3
A076187-004	AB4
A076187-005	AB1
A076187-005	AB2
A076187-005	AB3
A076187-005	AB4
A076187-006	AB1
A076187-006	AB2
A076187-006	AB3
A076187-006	AB4
A076187-007	AB1
A076187-007	AB2
A076187-007	AB3
A076187-007	AB4
A076187-008	AB1
A076187-008	AB2
A076187-008	AB3
A076187-008	AB4
A076187-009	AB1
A076187-009	AB2
A076187-009	AB3
A076187-009	AB4
A076187-010	AB1
A076187-010	AB2
A076187-010	AB3
A076187-010	AB4
A076187-011	AB1
A076187-011	AB2
A076187-011	AB3
A076187-011	AB4
A076187-012	AB1
A076187-012	AB2
A076187-012	AB3
A076187-012	AB4

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076187-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-008	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-009	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-010	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-011	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	RS	2002-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-012	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2006-12-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076187-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076187-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076187-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076187-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076187-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076187-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076187-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076187-008	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076187-009	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076187-010	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076187-011	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	RS	2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076187-012	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2006-12-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076187-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-008	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-009	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-010	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-011	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	RS	2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-012	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2006-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 52 · 2,064 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	A076187-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-001	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-001	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-001	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-002	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-002	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-002	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-003	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-003	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-003	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-004	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-004	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-004	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-004	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-005	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-005	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-005	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-005	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-006	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-006	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-006	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-006	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-007	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-007	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-007	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-007	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-008	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-008	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-008	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-008	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-009	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-009	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-009	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-009	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-010	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-010	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-010	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-010	AB4	4	`84e616aacf4f…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Cardinal Health 107, LLC	66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076187 application number: ANDA076187 ndc (product): 55154-5380 ndc (product): 55154-5362 ndc (product): 55154-4377 ndc (product): 55154-4376
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	db10e666-6204-56cc-e053-2995a90a9e08	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076187 application number: ANDA076187
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	fa15ac73-f4f6-7a6b-e053-6294a90a4f4e	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076187 application number: ANDA076187
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Mylan Institutional Inc.	cd69c192-cd3f-47e6-b0a6-c536ffed5c4b	2025-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076187 application number: ANDA076187 ndc (product): 42292-041 ndc (product): 42292-038 ndc (product): 42292-039 ndc (product): 42292-040
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Mylan Institutional Inc.	5723c7a7-2a1d-4ab6-bf39-b2165ae781a6	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076187 application number: ANDA076187 ndc (product): 51079-441 ndc (product): 51079-443 ndc (product): 51079-444 ndc (product): 51079-440 ndc (product): 51079-442 ndc (product): 51079-445
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Mylan Pharmaceuticals Inc.	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	2024-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076187 application number: ANDA076187 ndc (product): 0378-1821 ndc (product): 0378-1823

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 2 of 3 · 188 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-1821	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1821	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1821	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1821	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1821	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1821	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1821	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1821	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1823	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1823	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1823	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1823	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1823	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1823	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1823	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1823	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
42292-038	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
42292-038	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
42292-038	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
42292-039	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
42292-039	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
42292-039	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
42292-040	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
42292-040	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
42292-040	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
42292-041	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
42292-041	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
42292-041	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
50090-2826	Levothyroxine Sodium	levothyroxine sodium	A-S Medication Solutions	ANDA	Current
50090-2911	Levothyroxine Sodium	levothyroxine sodium	A-S Medication Solutions	ANDA	Current
51079-440	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
51079-440	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
51079-440	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
51079-441	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
51079-441	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
51079-441	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
51079-442	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
51079-442	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
51079-442	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
51079-443	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
51079-443	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
51079-443	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
51079-444	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
51079-444	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
51079-444	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
51079-445	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
51079-445	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
51079-445	Levothyroxine Sodium	levothyroxine sodium	Mylan Institutional Inc.	ANDA	Current
53808-0279	Levothyroxine Sodium	levothyroxine sodium	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0280	Levothyroxine Sodium	levothyroxine sodium	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0605	Levothyroxine Sodium	levothyroxine sodium	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0606	Levothyroxine Sodium	levothyroxine sodium	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0607	Levothyroxine Sodium	levothyroxine sodium	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0608	Levothyroxine Sodium	levothyroxine sodium	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0668	Levothyroxine Sodium	levothyroxine sodium	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0679	Levothyroxine Sodium	levothyroxine sodium	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0946	Levothyroxine Sodium	levothyroxine sodium	State of Florida DOH Central Pharmacy	ANDA	Current
53808-1054	Levothyroxine Sodium	levothyroxine sodium	State of Florida DOH Central Pharmacy	ANDA	Current
53808-1113	Levothyroxine Sodium	levothyroxine sodium	DOH CENTRAL PHARMACY	ANDA	Current
53808-1114	Levothyroxine Sodium	levothyroxine sodium	DOH CENTRAL PHARMACY	ANDA	Current
55154-4376	Levothyroxine Sodium	levothyroxine sodium	Cardinal Health	ANDA	Current
55154-4376	Levothyroxine Sodium	levothyroxine sodium	Cardinal Health	ANDA	Current
55154-4376	Levothyroxine Sodium	levothyroxine sodium	Cardinal Health	ANDA	Current
55154-4376	Levothyroxine Sodium	levothyroxine sodium	Cardinal Health 107, LLC	ANDA	Current
55154-4376	Levothyroxine Sodium	levothyroxine sodium	Cardinal Health	ANDA	Current
55154-4376	Levothyroxine Sodium	levothyroxine sodium	Cardinal Health	ANDA	Current
55154-4376	Levothyroxine Sodium	levothyroxine sodium	Cardinal Health	ANDA	Current
55154-4377	Levothyroxine Sodium	levothyroxine sodium	Cardinal Health	ANDA	Current
55154-4377	Levothyroxine Sodium	levothyroxine sodium	Cardinal Health	ANDA	Current
55154-4377	Levothyroxine Sodium	levothyroxine sodium	Cardinal Health 107, LLC	ANDA	Current
55154-4377	Levothyroxine Sodium	levothyroxine sodium	Cardinal Health	ANDA	Current
55154-4377	Levothyroxine Sodium	levothyroxine sodium	Cardinal Health	ANDA	Current
55154-5362	Levothyroxine Sodium	levothyroxine sodium	Cardinal Health	ANDA	Current
55154-5362	Levothyroxine Sodium	levothyroxine sodium	Cardinal Health	ANDA	Current
55154-5362	Levothyroxine Sodium	levothyroxine sodium	Cardinal Health	ANDA	Current
55154-5362	Levothyroxine Sodium	levothyroxine sodium	Cardinal Health 107, LLC	ANDA	Current
55154-5362	Levothyroxine Sodium	levothyroxine sodium	Cardinal Health	ANDA	Current
55154-5362	Levothyroxine Sodium	levothyroxine sodium	Cardinal Health	ANDA	Current
55154-5362	Levothyroxine Sodium	levothyroxine sodium	Cardinal Health	ANDA	Current
55154-5380	Levothyroxine Sodium	levothyroxine sodium	Cardinal Health	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43061	ORIG	2005-05-10
22544	SUPPL	2005-05-10
39509	ORIG	2004-02-18
22543	ORIG	2004-02-18
8875	ORIG	2004-02-18