Application 202231

Type: NDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	POWDER;INTRAVENOUS	100MCG/VIAL	Yes	Yes
002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	POWDER;INTRAVENOUS	200MCG/VIAL	Yes	Yes
003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	POWDER;INTRAVENOUS	500MCG/VIAL	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N202231-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24
N202231-002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24
N202231-003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N202231-001	AP
N202231-002	AP
N202231-003	AP

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N202231-001	9168238	2032-08-29	Drug product	2015-10-28
N202231-001	9168239	2032-08-29	Drug product	2015-10-28
N202231-001	9006289	2032-10-03	Drug product	2015-04-14
N202231-002	9168238	2032-08-29	Drug product	2015-10-28
N202231-002	9168239	2032-08-29	Drug product	2015-10-28
N202231-002	9006289	2032-10-03	Drug product	2015-04-14
N202231-003	9168238	2032-08-29	Drug product	2015-10-28
N202231-003	9168239	2032-08-29	Drug product	2015-10-28
N202231-003	9006289	2032-10-03	Drug product	2015-04-14

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 4 · 126 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
2026-08-18 06:07:40	2026-07	N202231-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202231-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202231-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202231-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202231-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202231-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202231-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202231-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202231-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202231-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202231-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202231-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202231-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202231-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202231-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202231-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202231-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202231-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202231-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202231-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202231-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202231-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202231-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202231-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202231-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202231-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202231-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202231-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202231-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202231-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202231-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202231-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202231-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202231-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202231-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202231-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202231-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202231-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202231-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202231-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2011-06-24	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N202231-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202231-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202231-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202231-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202231-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202231-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202231-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202231-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202231-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202231-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202231-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202231-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202231-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202231-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202231-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202231-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202231-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202231-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202231-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202231-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202231-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202231-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202231-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202231-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202231-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202231-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202231-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202231-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202231-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202231-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202231-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202231-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202231-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202231-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202231-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202231-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202231-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202231-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202231-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202231-001	AP	1	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 378 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N202231-001	9168238	2032-08-29	Drug product	2015-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202231-001	9168239	2032-08-29	Drug product	2015-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202231-001	9006289	2032-10-03	Drug product	2015-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202231-002	9168238	2032-08-29	Drug product	2015-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202231-002	9168239	2032-08-29	Drug product	2015-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202231-002	9006289	2032-10-03	Drug product	2015-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202231-003	9168238	2032-08-29	Drug product	2015-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202231-003	9168239	2032-08-29	Drug product	2015-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202231-003	9006289	2032-10-03	Drug product	2015-04-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202231-001	9168238	2032-08-29	Drug product	2015-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202231-001	9168239	2032-08-29	Drug product	2015-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202231-001	9006289	2032-10-03	Drug product	2015-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202231-002	9168238	2032-08-29	Drug product	2015-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202231-002	9168239	2032-08-29	Drug product	2015-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202231-002	9006289	2032-10-03	Drug product	2015-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202231-003	9168238	2032-08-29	Drug product	2015-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202231-003	9168239	2032-08-29	Drug product	2015-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202231-003	9006289	2032-10-03	Drug product	2015-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202231-001	9168238	2032-08-29	Drug product	2015-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202231-001	9168239	2032-08-29	Drug product	2015-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202231-001	9006289	2032-10-03	Drug product	2015-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202231-002	9168238	2032-08-29	Drug product	2015-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202231-002	9168239	2032-08-29	Drug product	2015-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202231-002	9006289	2032-10-03	Drug product	2015-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202231-003	9168238	2032-08-29	Drug product	2015-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202231-003	9168239	2032-08-29	Drug product	2015-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202231-003	9006289	2032-10-03	Drug product	2015-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202231-001	9168238	2032-08-29	Drug product	2015-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202231-001	9168239	2032-08-29	Drug product	2015-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202231-001	9006289	2032-10-03	Drug product	2015-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202231-002	9168238	2032-08-29	Drug product	2015-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202231-002	9168239	2032-08-29	Drug product	2015-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202231-002	9006289	2032-10-03	Drug product	2015-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202231-003	9168238	2032-08-29	Drug product	2015-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202231-003	9168239	2032-08-29	Drug product	2015-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202231-003	9006289	2032-10-03	Drug product	2015-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202231-001	9168238	2032-08-29	Drug product	2015-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202231-001	9168239	2032-08-29	Drug product	2015-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202231-001	9006289	2032-10-03	Drug product	2015-04-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202231-002	9168238	2032-08-29	Drug product	2015-10-28	`fd3edfee7708…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	ENDO USA, Inc.	9d815416-11c9-470e-a82f-89b0bf232e12	2025-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202231 application number: NDA202231 ndc (product): 42023-203 ndc (product): 42023-202 ndc (product): 42023-201
Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Fresenius Kabi USA, LLC	ce990712-49c1-4f66-9ee4-c770e8ec394c	2025-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202231 application number: NDA202231 ndc (product): 63323-647 ndc (product): 63323-648 ndc (product): 63323-649
Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Fresenius Kabi USA, LLC	152d071f-d4aa-46d2-b397-61c1cabdd86d	2024-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202231 application number: NDA202231 ndc (product): 63323-648 ndc (product): 63323-649
Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Fresenius Kabi USA, LLC	f88f44d8-2f18-4155-9d78-6323d19fbafe	2024-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202231 application number: NDA202231 ndc (product): 63323-649

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42023-201	Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Par Pharmaceutical Inc.	NDA	Current
42023-201	Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Par Pharmaceutical Inc.	NDA	Current
42023-201	Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Par Pharmaceutical Inc.	NDA	Current
42023-202	Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Par Pharmaceutical Inc.	NDA	Current
42023-202	Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Par Pharmaceutical Inc.	NDA	Current
42023-202	Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Par Pharmaceutical Inc.	NDA	Current
42023-203	Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Par Pharmaceutical Inc.	NDA	Current
42023-203	Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Par Pharmaceutical Inc.	NDA	Current
42023-203	Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Par Pharmaceutical Inc.	NDA	Current
63323-647	Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Fresenius Kabi USA, LLC	NDA	Current
63323-647	Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Fresenius Kabi USA, LLC	NDA	Current
63323-648	Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Fresenius Kabi USA, LLC	NDA	Current
63323-648	Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Fresenius Kabi USA, LLC	NDA	Current
63323-648	Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Fresenius Kabi USA, LLC	NDA	Current
63323-648	Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Fresenius Kabi USA, LLC	NDA	Current
63323-649	Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Fresenius Kabi USA, LLC	NDA	Current
63323-649	Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Fresenius Kabi USA, LLC	NDA	Current
63323-649	Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Fresenius Kabi USA, LLC	NDA	Current
63323-649	Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Fresenius Kabi USA, LLC	NDA	Current
63323-649	Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Fresenius Kabi USA, LLC	NDA	Current
63323-649	Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Fresenius Kabi USA, LLC	NDA	Current
66794-647	Levothyroxine Sodium	Levothyroxine Sodium	Piramal Critical Care, Inc.	NDA AUTHORIZED GENERIC	Current
66794-647	Levothyroxine Sodium	Levothyroxine Sodium	Piramal Critical Care, Inc.	NDA AUTHORIZED GENERIC	Current
66794-648	Levothyroxine Sodium	Levothyroxine Sodium	Piramal Critical Care, Inc.	NDA AUTHORIZED GENERIC	Current
66794-648	Levothyroxine Sodium	Levothyroxine Sodium	Piramal Critical Care, Inc.	NDA AUTHORIZED GENERIC	Current
66794-649	Levothyroxine Sodium	Levothyroxine Sodium	Piramal Critical Care, Inc.	NDA AUTHORIZED GENERIC	Current
66794-649	Levothyroxine Sodium	Levothyroxine Sodium	Piramal Critical Care, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9993	SUPPL	2012-12-26
19298	SUPPL	2012-12-21
44848	ORIG	2012-03-09
22879	ORIG	2012-03-09
32210	ORIG	2011-07-05
19297	ORIG	2011-06-28