Application 212399

Type: ANDA
Sponsor: ACCORD HLTHCARE

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	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
009	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
010	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
011	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
012	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.3MG **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	Approval date
A212399-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19
A212399-002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19
A212399-003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19
A212399-004	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19
A212399-005	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19
A212399-006	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19
A212399-007	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19
A212399-008	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19
A212399-009	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19
A212399-010	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19
A212399-011	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19
A212399-012	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212399-001	AB1
A212399-001	AB2
A212399-001	AB3
A212399-001	AB4
A212399-002	AB1
A212399-002	AB2
A212399-002	AB3
A212399-002	AB4
A212399-003	AB1
A212399-003	AB2
A212399-003	AB3
A212399-003	AB4
A212399-004	AB1
A212399-004	AB2
A212399-004	AB3
A212399-004	AB4
A212399-005	AB1
A212399-005	AB2
A212399-005	AB3
A212399-005	AB4
A212399-006	AB1
A212399-006	AB2
A212399-006	AB3
A212399-006	AB4
A212399-007	AB1
A212399-007	AB2
A212399-007	AB3
A212399-007	AB4
A212399-008	AB1
A212399-008	AB2
A212399-008	AB3
A212399-008	AB4
A212399-009	AB1
A212399-009	AB2
A212399-009	AB3
A212399-009	AB4
A212399-010	AB1
A212399-010	AB2
A212399-010	AB3
A212399-010	AB4
A212399-011	AB1
A212399-011	AB2
A212399-011	AB3
A212399-011	AB4
A212399-012	AB1
A212399-012	AB2
A212399-012	AB3
A212399-012	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 12 · 456 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	A212399-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212399-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212399-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212399-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212399-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212399-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212399-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212399-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212399-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212399-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212399-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212399-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212399-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212399-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212399-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212399-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212399-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212399-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 36 · 1,440 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	A212399-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-001	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-001	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-001	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-002	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-002	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-002	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-003	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-003	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-003	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-004	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-004	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-004	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-004	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-005	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-005	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-005	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-005	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-006	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-006	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-006	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-006	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-007	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-007	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-007	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-007	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-008	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-008	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-008	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-008	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-009	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-009	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-009	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-009	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-010	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-010	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-010	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-010	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 3 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	c29a417b-95b0-4c9b-85e6-ec884049edb1	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	3453af75-8c2e-421f-9a08-24751936df41	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399 ndc (product): 50090-6104
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	1af49c9f-93da-4838-899b-9445083a154b	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	eb149423-070f-49ae-ab18-5afee09d06fb	2025-11-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Accord Healthcare Inc.	a6233381-3043-4e9a-aaa6-a6b105e5142b	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399 ndc (product): 16729-447 ndc (product): 16729-449 ndc (product): 16729-452 ndc (product): 16729-451 ndc (product): 16729-454 ndc (product): 16729-453 ndc (product): 16729-456 ndc (product): 16729-448 ndc (product): 16729-458 ndc (product): 16729-450 ndc (product): 16729-455 ndc (product): 16729-457
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	0fa2e2f5-401b-45c1-b6a5-d02f6faf509d	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	70d84fe0-afc4-4ef2-b4d8-f156abac3d1f	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399 ndc (product): 50090-6089
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	ff7f5eff-4c90-4aa0-8915-704f92dea8aa	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	RedPharm Drug, Inc	fcb196a2-31a6-437a-e053-6294a90a98ad	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Redpharm drug	fa1bbb6e-ed15-07c9-e053-6294a90aa4a0	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Redpharm drug	fa2aebcd-3cd8-5128-e053-6294a90ac612	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Direct Rx	dd032289-acee-49fc-e053-2a95a90a5999	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Direct_rx	2b4bbe49-4bd0-ba16-e063-6394a90acefc	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Direct_Rx	2b361866-e981-567c-e063-6294a90a5a5c	2025-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	576dcd01-d151-42ac-acd1-480a13bae176	2024-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	893f9d10-7ce5-4ae6-8f03-dfde35ca6c30	2024-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	f23cacf6-0509-4e6b-bb59-6f1c17b16411	2024-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	6edb9499-b869-4ec8-82d7-56d267fd3dec	2024-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	2ee67e24-d72f-4419-a7d2-95bb44d9dd26	2024-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	b57d0cc5-9fc7-496a-9bfa-417a288bb825	2024-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399

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 1 of 2 · 150 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16729-447	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-447	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-447	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-447	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-448	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-448	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-448	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-448	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-448	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-448	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-448	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-449	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-449	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-449	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-449	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-449	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-449	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-449	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-450	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-450	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-450	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-450	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-450	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-450	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-450	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-451	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-451	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-451	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-451	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-451	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-452	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-452	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-452	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-452	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-452	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-452	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-452	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-453	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-453	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-453	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-453	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-453	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-453	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-454	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-454	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-454	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-454	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-454	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-454	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-454	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-455	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-455	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-455	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-455	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-455	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-455	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-455	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-456	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-456	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-456	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-456	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-456	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-456	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-457	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-457	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-457	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-457	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-457	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-457	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-458	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-458	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-458	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
16729-458	Levothyroxine sodium	Levothyroxine Sodium	Accord Healthcare Inc.	ANDA	Current
50090-6087	Levothyroxine sodium	Levothyroxine Sodium	A-S Medication Solutions	ANDA	Current
50090-6089	Levothyroxine sodium	Levothyroxine Sodium	A-S Medication Solutions	ANDA	Current
50090-6090	Levothyroxine sodium	Levothyroxine Sodium	A-S Medication Solutions	ANDA	Current
50090-6100	Levothyroxine sodium	Levothyroxine Sodium	A-S Medication Solutions	ANDA	Current
50090-6101	Levothyroxine sodium	Levothyroxine Sodium	A-S Medication Solutions	ANDA	Current
50090-6103	Levothyroxine sodium	Levothyroxine Sodium	A-S Medication Solutions	ANDA	Current
50090-6104	Levothyroxine sodium	Levothyroxine Sodium	A-S Medication Solutions	ANDA	Current