Application 021292

Type: NDA
Sponsor: PROVELL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EUTHYROX	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
002	EUTHYROX	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
003	EUTHYROX	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
004	EUTHYROX	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
005	EUTHYROX	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
006	EUTHYROX	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
007	EUTHYROX	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
008	EUTHYROX	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
009	EUTHYROX	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
010	EUTHYROX	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
011	EUTHYROX	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
012	EUTHYROX	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.3MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
N021292-001	EUTHYROX	LEVOTHYROXINE SODIUM	0.025MG	TABLET / ORAL	2002-05-31
N021292-002	EUTHYROX	LEVOTHYROXINE SODIUM	0.05MG	TABLET / ORAL	2002-05-31
N021292-003	EUTHYROX	LEVOTHYROXINE SODIUM	0.075MG	TABLET / ORAL	2002-05-31
N021292-004	EUTHYROX	LEVOTHYROXINE SODIUM	0.088MG	TABLET / ORAL	2002-05-31
N021292-005	EUTHYROX	LEVOTHYROXINE SODIUM	0.1MG	TABLET / ORAL	2002-05-31
N021292-006	EUTHYROX	LEVOTHYROXINE SODIUM	0.112MG	TABLET / ORAL	2002-05-31
N021292-007	EUTHYROX	LEVOTHYROXINE SODIUM	0.125MG	TABLET / ORAL	2002-05-31
N021292-008	EUTHYROX	LEVOTHYROXINE SODIUM	0.137MG	TABLET / ORAL	2002-05-31
N021292-009	EUTHYROX	LEVOTHYROXINE SODIUM	0.15MG	TABLET / ORAL	2002-05-31
N021292-010	EUTHYROX	LEVOTHYROXINE SODIUM	0.175MG	TABLET / ORAL	2002-05-31
N021292-011	EUTHYROX	LEVOTHYROXINE SODIUM	0.2MG	TABLET / ORAL	2002-05-31
N021292-012	EUTHYROX	LEVOTHYROXINE SODIUM	0.3MG	TABLET / ORAL	2002-05-31

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 2 of 14 · 528 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
2026-02-19 14:30 UTC	2026-02	N021292-005	EUTHYROX	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-006	EUTHYROX	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-007	EUTHYROX	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-008	EUTHYROX	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-009	EUTHYROX	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-010	EUTHYROX	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-011	EUTHYROX	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-012	EUTHYROX	0.3MG	TABLET / ORAL		2002-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-001	EUTHYROX	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-002	EUTHYROX	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-003	EUTHYROX	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-004	EUTHYROX	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-005	EUTHYROX	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-006	EUTHYROX	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-007	EUTHYROX	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-008	EUTHYROX	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-009	EUTHYROX	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-010	EUTHYROX	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-011	EUTHYROX	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-012	EUTHYROX	0.3MG	TABLET / ORAL		2002-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021292-001	EUTHYROX	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-002	EUTHYROX	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-003	EUTHYROX	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-004	EUTHYROX	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-005	EUTHYROX	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-006	EUTHYROX	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-007	EUTHYROX	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-008	EUTHYROX	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-009	EUTHYROX	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-010	EUTHYROX	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-011	EUTHYROX	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-012	EUTHYROX	0.3MG	TABLET / ORAL		2002-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021292-001	EUTHYROX	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021292-002	EUTHYROX	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021292-003	EUTHYROX	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021292-004	EUTHYROX	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021292-005	EUTHYROX	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021292-006	EUTHYROX	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021292-007	EUTHYROX	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021292-008	EUTHYROX	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB2	2002-05-31	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 11 · 440 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021292-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-003	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-004	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-005	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-006	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-007	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-008	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-009	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-010	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-011	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-003	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-004	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-005	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-006	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-007	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-008	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-009	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-010	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-011	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021292-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-003	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-004	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-005	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-006	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-007	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-008	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-009	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-010	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-011	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021292-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021292-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021292-003	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021292-004	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021292-005	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021292-006	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021292-007	AB2	1	`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 14 · 272 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	bc9385d0-5c67-4bde-94da-e621347e2cba	2026-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	4c903249-69e9-4168-a9d1-22e6c2c1eb22	2026-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	6f25cbb3-0358-4778-b8f0-f76479a2dcc5	2026-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	7fd988be-ab3d-406d-a55d-1e5a8a2101cc	2026-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	6108759a-783e-42ca-b078-6a3cd84ce901	2026-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	13e03769-9a4f-497f-9afa-95bf525090b3	2026-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	NorthStar RxLLC	58f4dc90-3648-49dc-a7e1-baf918a773b5	2026-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals, Inc.	597ea445-d926-adc6-e063-6394a90a6446	2026-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	55f4c679-86cb-b97f-e063-6294a90ad5ef	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	55f67831-4680-edbf-e063-6294a90a1d36	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	489ffba8-983e-478f-8f62-fe08bf3d0e0b	2026-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	544d67eb-8487-cb5d-e063-6394a90a3110	2026-06-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	3b282e57-1009-4d2c-8ca2-9cca9f791937	2026-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	53e84179-fe2a-5696-e063-6394a90a8566	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Coupler LLC	5383a4d8-319a-5bf6-e063-6294a90a5497	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	abe173cc-1579-43a5-b12d-a31958d0a539	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Cardinal Health 107, LLC	66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	53316e75-9897-4935-e063-6294a90a94cf	2026-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	5852d874-1ebc-49ff-b6c2-1dd513fca784	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	c8ae9dc4-836f-4912-80d7-684fd374f40a	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 55 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72305-025	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-025	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-025	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-025	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-025	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-050	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-050	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-050	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-050	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-050	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-075	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-075	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-075	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-075	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-075	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-088	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-088	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-088	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-088	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-088	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-100	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-100	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-100	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-100	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-100	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-112	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-112	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-112	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-112	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-112	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-125	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-125	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-125	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-125	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-125	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-137	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-137	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-137	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-137	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-137	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-150	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-150	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-150	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-150	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-150	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-175	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-175	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-175	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-175	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-175	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-200	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-200	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-200	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-200	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-200	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70915	SUPPL	2022-05-03
70873	SUPPL	2022-05-02
55504	SUPPL	2018-09-18
55503	SUPPL	2018-09-18
55502	SUPPL	2018-09-18
55498	SUPPL	2018-09-18
55497	SUPPL	2018-09-18
55496	SUPPL	2018-09-18
36600	SUPPL	2009-04-03
4947	SUPPL	2009-04-01
21579	ORIG	2004-06-29
15125	ORIG	2002-05-31
4946	ORIG	2002-05-31