Application 021342

Type: NDA
Sponsor: CEDIPROF INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVO-T	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
002	LEVO-T	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
003	LEVO-T	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
004	LEVO-T	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
005	LEVO-T	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
006	LEVO-T	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
007	LEVO-T	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
008	LEVO-T	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
009	LEVO-T	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
010	LEVO-T	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
011	LEVO-T	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
012	LEVO-T	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	Approval date
N021342-001	LEVO-T	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-002	LEVO-T	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-003	LEVO-T	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-004	LEVO-T	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-005	LEVO-T	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-006	LEVO-T	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-007	LEVO-T	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-008	LEVO-T	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-009	LEVO-T	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-010	LEVO-T	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-011	LEVO-T	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-012	LEVO-T	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2003-12-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 36 matching rows.

Application-product, TE code table
Application-product	TE code
N021342-001	AB1
N021342-001	AB2
N021342-001	AB3
N021342-002	AB1
N021342-002	AB2
N021342-002	AB3
N021342-003	AB1
N021342-003	AB2
N021342-003	AB3
N021342-004	AB1
N021342-004	AB2
N021342-004	AB3
N021342-005	AB1
N021342-005	AB2
N021342-005	AB3
N021342-006	AB1
N021342-006	AB2
N021342-006	AB3
N021342-007	AB1
N021342-007	AB2
N021342-007	AB3
N021342-008	AB1
N021342-008	AB2
N021342-008	AB3
N021342-009	AB1
N021342-009	AB2
N021342-009	AB3
N021342-010	AB1
N021342-010	AB2
N021342-010	AB3
N021342-011	AB1
N021342-011	AB2
N021342-011	AB3
N021342-012	AB1
N021342-012	AB2
N021342-012	AB3

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	N021342-001	LEVO-T	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-002	LEVO-T	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-003	LEVO-T	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-004	LEVO-T	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-005	LEVO-T	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-006	LEVO-T	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-007	LEVO-T	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-008	LEVO-T	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-009	LEVO-T	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-010	LEVO-T	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-011	LEVO-T	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-012	LEVO-T	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2003-12-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021342-001	LEVO-T	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-002	LEVO-T	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-003	LEVO-T	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-004	LEVO-T	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-005	LEVO-T	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-006	LEVO-T	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-007	LEVO-T	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-008	LEVO-T	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-009	LEVO-T	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-010	LEVO-T	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-011	LEVO-T	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-012	LEVO-T	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2003-12-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021342-001	LEVO-T	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-002	LEVO-T	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-003	LEVO-T	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-004	LEVO-T	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-005	LEVO-T	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-006	LEVO-T	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-007	LEVO-T	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-008	LEVO-T	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-009	LEVO-T	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-010	LEVO-T	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-011	LEVO-T	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-012	LEVO-T	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2003-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021342-001	LEVO-T	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021342-002	LEVO-T	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021342-003	LEVO-T	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021342-004	LEVO-T	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 39 · 1,548 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	N021342-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-001	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-001	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-002	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-002	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-003	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-003	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-004	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-004	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-004	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-005	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-005	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-005	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-006	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-006	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-006	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-007	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-007	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-007	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-008	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-008	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-008	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-009	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-009	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-009	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-010	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-010	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-010	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-011	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-011	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-011	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-012	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-012	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021342-012	AB3	3	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021342-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-001	AB2	2	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-001	AB3	3	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021342-002	AB1	1	`caaa826d4ba7…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021342-001	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-002	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-003	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-004	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-005	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-006	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-007	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-008	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-009	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-010	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-011	6399101	2020-03-30	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021342-001	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-002	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-003	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-004	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-005	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-006	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-007	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-008	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-009	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-010	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-011	6399101	2020-03-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021342-001	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-002	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-003	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-004	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-005	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-006	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-007	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-008	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-009	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-010	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-011	6399101	2020-03-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021342-001	6399101	2020-03-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021342-002	6399101	2020-03-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021342-003	6399101	2020-03-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021342-004	6399101	2020-03-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021342-005	6399101	2020-03-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021342-006	6399101	2020-03-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021342-007	6399101	2020-03-30	`3f01610625f2…`

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 2 of 3 · 48 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	66bb0ba9-cd63-4817-907f-7b8ad5dc6685	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	8ac112c3-1e06-4fdb-a7af-2ee988de5b15	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	69fb5cd6-90ba-487d-a754-07c664a1fdd1	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f6c92836-95e1-1402-e053-6394a90a2f5e	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Lannett Company, Inc	a8db0f7d-8863-9309-e053-2995a90a284a	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342 ndc (product): 0527-3282 ndc (product): 0527-3284 ndc (product): 0527-3281 ndc (product): 0527-3286 ndc (product): 0527-3289 ndc (product): 0527-3285 ndc (product): 0527-3287 ndc (product): 0527-3290 ndc (product): 0527-3280 ndc (product): 0527-3291 ndc (product): 0527-3283 ndc (product): 0527-3288
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f31b5d54-7536-4290-e053-2a95a90ac235	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f32b4a01-edea-fc85-e053-2995a90ac175	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f31a35cb-fc54-8872-e053-2a95a90ad8e7	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f31ba297-e042-187a-e053-2a95a90a4861	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f31d987d-6836-b4a7-e053-2a95a90a8f7b	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f86e74e1-0d55-8d0e-e053-6394a90a07bf	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f86efc89-f784-c8bb-e053-6294a90a63c9	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	db9821db-3fe3-d1cf-e053-2a95a90a0252	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f86fab39-bbd9-a51c-e053-6294a90accd0	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	472ec9e7-c1db-bf8c-e063-6394a90a2c07	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	4302e36f-0b5b-f645-e063-6394a90a010f	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	9e588c43-b9b5-478e-99f7-e197add3cd26	2025-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	91afb351-f067-49a2-bdf0-336ea209718d	2025-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	237cc591-c40b-416f-ac00-96cd61bc59dc	2025-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342 ndc (product): 50090-5654
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	8f83fd60-5aa7-4e7f-a6e9-917e2c1abf27	2024-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342

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 5 · 350 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-3280	Levothyroxine Sodium	Levothyroxine Sodium	Lannett Company, Inc	NDA AUTHORIZED GENERIC	Current
0527-3281	Levothyroxine Sodium	Levothyroxine Sodium	Lannett Company, Inc	NDA AUTHORIZED GENERIC	Current
0527-3282	Levothyroxine Sodium	Levothyroxine Sodium	Lannett Company, Inc	NDA AUTHORIZED GENERIC	Current
0527-3283	Levothyroxine Sodium	Levothyroxine Sodium	Lannett Company, Inc	NDA AUTHORIZED GENERIC	Current
0527-3284	Levothyroxine Sodium	Levothyroxine Sodium	Lannett Company, Inc	NDA AUTHORIZED GENERIC	Current
0527-3285	Levothyroxine Sodium	Levothyroxine Sodium	Lannett Company, Inc	NDA AUTHORIZED GENERIC	Current
0527-3286	Levothyroxine Sodium	Levothyroxine Sodium	Lannett Company, Inc	NDA AUTHORIZED GENERIC	Current
0527-3287	Levothyroxine Sodium	Levothyroxine Sodium	Lannett Company, Inc	NDA AUTHORIZED GENERIC	Current
0527-3288	Levothyroxine Sodium	Levothyroxine Sodium	Lannett Company, Inc	NDA AUTHORIZED GENERIC	Current
0527-3289	Levothyroxine Sodium	Levothyroxine Sodium	Lannett Company, Inc	NDA AUTHORIZED GENERIC	Current
0527-3290	Levothyroxine Sodium	Levothyroxine Sodium	Lannett Company, Inc	NDA AUTHORIZED GENERIC	Current
0527-3291	Levothyroxine Sodium	Levothyroxine Sodium	Lannett Company, Inc	NDA AUTHORIZED GENERIC	Current
0781-5180	Levothyroxine Sodium	Levothyroxine Sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5180	Levothyroxine Sodium	Levothyroxine Sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5180	Levothyroxine Sodium	Levothyroxine Sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5180	Levothyroxine Sodium	Levothyroxine Sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5181	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5181	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5181	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5181	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5182	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5182	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5182	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5182	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5183	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5183	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5183	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5183	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5184	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5184	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5184	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5184	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5185	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5185	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5185	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5185	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5186	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5186	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5186	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5186	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5187	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5187	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5187	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5187	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5188	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5188	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5188	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5188	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5189	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5189	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5189	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5189	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5190	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5190	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5190	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5190	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5191	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5191	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5191	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-5191	Levothyroxine sodium	Levothyroxine sodium	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
33261-337	Levothyroxine sodium	Levothyroxine sodium	Aidarex Pharmaceuticals LLC	NDA	Current
35356-933	Levothyroxine sodium	Levothyroxine sodium	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
35356-955	Levothyroxine sodium	Levothyroxine sodium	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
43353-296	Levothyroxine sodium	Levothyroxine sodium	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
50090-0901	Levothyroxine sodium	Levothyroxine sodium	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-5644	Levothyroxine Sodium	Levothyroxine Sodium	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-5651	Levothyroxine Sodium	Levothyroxine Sodium	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-5653	Levothyroxine Sodium	Levothyroxine Sodium	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-5654	Levothyroxine Sodium	Levothyroxine Sodium	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-5655	Levothyroxine Sodium	Levothyroxine Sodium	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-5658	Levothyroxine Sodium	Levothyroxine Sodium	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-5661	Levothyroxine Sodium	Levothyroxine Sodium	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-5669	Levothyroxine Sodium	Levothyroxine Sodium	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-5821	Levothyroxine Sodium	Levothyroxine Sodium	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-5887	Levothyroxine Sodium	Levothyroxine Sodium	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50436-5181	Levothyroxine sodium	Levothyroxine sodium	Unit Dose Services	NDA AUTHORIZED GENERIC	Current
50436-5182	Levothyroxine sodium	Levothyroxine sodium	Unit Dose Services	NDA AUTHORIZED GENERIC	Current
50436-5183	Levothyroxine sodium	Levothyroxine sodium	Unit Dose Services	NDA AUTHORIZED GENERIC	Current
51655-091	Levothyroxine	Levothyroxine	Northwind Pharmaceuticals, LLC	NDA	Current
51655-095	Levothyroxine Sodium	Levothyroxine Sodium	Northwind Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85838	SUPPL	2026-05-21
85864	SUPPL	2026-05-11
50625	SUPPL	2017-12-07
50624	SUPPL	2017-12-07
27524	SUPPL	2011-03-11
15222	SUPPL	2009-06-22
27523	SUPPL	2009-06-17
27522	SUPPL	2008-06-13
27521	SUPPL	2008-06-13
36694	SUPPL	2008-06-12
15221	SUPPL	2008-06-12
42112	SUPPL	2005-05-13
42111	SUPPL	2005-05-13
5088	SUPPL	2004-06-24
5087	SUPPL	2004-06-24
36692	SUPPL	2003-12-11
5085	SUPPL	2003-12-11
36693	SUPPL	2003-08-28
5086	SUPPL	2003-08-28
69369	ORIG	2002-06-19
21609	ORIG	2002-06-19
27520	ORIG	2002-03-01
15220	ORIG	2002-03-01