Application 021210

Type: NDA
Sponsor: STEVENS J

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021210-001	UNITHROID	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-002	UNITHROID	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-003	UNITHROID	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-004	UNITHROID	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-005	UNITHROID	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-006	UNITHROID	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-007	UNITHROID	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-008	UNITHROID	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-009	UNITHROID	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-010	UNITHROID	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-011	UNITHROID	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD, RS	2000-08-21
N021210-012	UNITHROID	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2008-02-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021210-001	AB1
N021210-001	AB2
N021210-001	AB3
N021210-002	AB1
N021210-002	AB2
N021210-002	AB3
N021210-003	AB1
N021210-003	AB2
N021210-003	AB3
N021210-004	AB1
N021210-004	AB2
N021210-004	AB3
N021210-005	AB1
N021210-005	AB2
N021210-005	AB3
N021210-006	AB1
N021210-006	AB2
N021210-006	AB3
N021210-007	AB1
N021210-007	AB2
N021210-007	AB3
N021210-008	AB1
N021210-008	AB2
N021210-008	AB3
N021210-009	AB1
N021210-009	AB2
N021210-009	AB3
N021210-010	AB1
N021210-010	AB2
N021210-010	AB3
N021210-011	AB1
N021210-011	AB2
N021210-011	AB3
N021210-012	AB1
N021210-012	AB2
N021210-012	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021210-001	UNITHROID	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-002	UNITHROID	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-003	UNITHROID	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-004	UNITHROID	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-005	UNITHROID	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-006	UNITHROID	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-007	UNITHROID	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-008	UNITHROID	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-009	UNITHROID	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-010	UNITHROID	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-011	UNITHROID	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD, RS	2000-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-012	UNITHROID	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2008-02-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021210-001	UNITHROID	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-002	UNITHROID	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-003	UNITHROID	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-004	UNITHROID	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-005	UNITHROID	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-006	UNITHROID	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-007	UNITHROID	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-008	UNITHROID	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-009	UNITHROID	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-010	UNITHROID	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-011	UNITHROID	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD, RS	2000-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-012	UNITHROID	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2008-02-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021210-001	UNITHROID	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-002	UNITHROID	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-003	UNITHROID	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-004	UNITHROID	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-005	UNITHROID	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-006	UNITHROID	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-007	UNITHROID	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-008	UNITHROID	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-009	UNITHROID	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-010	UNITHROID	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-011	UNITHROID	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD, RS	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-012	UNITHROID	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2008-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021210-001	UNITHROID	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021210-002	UNITHROID	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021210-003	UNITHROID	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021210-004	UNITHROID	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`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	N021210-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-001	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-001	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-002	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-002	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-003	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-003	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-004	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-004	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-004	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-005	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-005	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-005	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-006	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-006	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-006	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-007	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-007	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-007	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-008	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-008	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-008	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-009	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-009	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-009	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-010	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-010	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-010	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-011	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-011	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-011	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-012	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-012	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-012	AB3	3	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021210-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-001	AB2	2	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-001	AB3	3	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-002	AB1	1	`caaa826d4ba7…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	Exact identifier application applno (NDA): 021210 application number: NDA021210
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	c968836a-f94c-4d13-e053-2995a90a8df5	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210 ndc (product): 51655-705 ndc (product): 51655-694 ndc (product): 51655-687 ndc (product): 51655-696
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Amneal Pharmaceuticals NY LLC	fca88c97-5cd4-4834-ba87-deb5bd637788	2024-12-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	2f0657d5-3e5c-4249-bfaa-7f5ef1528672	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	97e28b00-9913-463f-9de2-08c828edbe67	2020-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	05ab038e-45fa-488e-a05e-12a2dd3564c1	2020-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	b81720f9-2836-4c1d-8691-0f6acef13316	2020-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	434075d5-a82b-4f17-85e6-4c1922663dbc	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	18c7c63a-642e-47fe-a8ee-12aaf652b2aa	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Unithroid	LEVOTHYROXINE SODIUM	Amneal Pharmaceuticals LLC	07562e72-7eaa-4ce6-94f0-e08814787e50	2019-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210 ndc (product): 60846-812 ndc (product): 60846-810 ndc (product): 60846-809 ndc (product): 60846-803 ndc (product): 60846-801 ndc (product): 60846-804 ndc (product): 60846-811 ndc (product): 60846-807 ndc (product): 60846-808 ndc (product): 60846-806 ndc (product): 60846-805 ndc (product): 60846-802

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 3 of 6 · 431 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51655-687	Levothyroxine Sodium	Levothyroxine Sodium	Northwind Pharmaceuticals	NDA	Current
51655-694	Levothyroxine Sodium	Levothyroxine Sodium	Northwind Pharmaceuticals	NDA	Current
51655-696	Levothyroxine Sodium	Levothyroxine Sodium	Northwind Pharmaceuticals	NDA	Current
51655-696	Levothyroxine Sodium	Levothyroxine Sodium	Northwind Pharmaceuticals	NDA	Current
51655-705	Levothyroxine Sodium	Levothyroxine Sodium	Northwind Pharmaceuticals	NDA	Current
51655-705	Levothyroxine Sodium	Levothyroxine Sodium	Northwind Pharmaceuticals	NDA	Current
52959-089	Levothyroxine Sodium	Levothyroxine Sodium	H.J. Harkins Company, Inc.	NDA	Current
52959-920	Levothyroxine Sodium	Levothyroxine Sodium	H.J. Harkins Company, Inc.	NDA	Current
53002-1019	Levothyroxine Sodium	Levothyroxine Sodium	RPK Pharmaceuticals, Inc.	NDA	Current
53002-1099	Levothyroxine Sodium	Levothyroxine Sodium	RPK Pharmaceuticals, Inc.	NDA	Current
53002-1112	Levothyroxine Sodium	Levothyroxine Sodium	RPK Pharmaceuticals, Inc.	NDA	Current
53002-1112	Levothyroxine Sodium	Levothyroxine Sodium	RPK Pharmaceuticals, Inc.	NDA	Current
53002-1212	Levothyroxine Sodium	Levothyroxine Sodium	RPK Pharmaceuticals, Inc.	NDA	Current
53002-3490	Levothyroxine Sodium	Levothyroxine Sodium	RPK Pharmaceuticals, Inc.	NDA	Current
53002-3490	Levothyroxine Sodium	Levothyroxine Sodium	RPK Pharmaceuticals, Inc.	NDA	Current
53808-0446	Levothyroxine Sodium	Levothyroxine Sodium	State of Florida DOH Central Pharmacy	NDA	Current
53808-0447	Levothyroxine Sodium	Levothyroxine Sodium	State of Florida DOH Central Pharmacy	NDA	Current
53808-0449	Levothyroxine Sodium	Levothyroxine Sodium	State of Florida DOH Central Pharmacy	NDA	Current
53808-0846	Levothyroxine Sodium	Levothyroxine Sodium	State of Florida DOH Central Pharmacy	NDA	Current
55289-076	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-076	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-154	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-858	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-858	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55700-405	Levothyroxine Sodium	Levothyroxine Sodium	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
55700-707	Levothyroxine Sodium	Levothyroxine Sodium	Quality Care Products, LLC	NDA	Current
55700-717	Levothyroxine Sodium	Levothyroxine Sodium	Quality Care Products, LLC	NDA	Current
60760-339	Levothyroxine Sodium	Levothyroxine Sodium	St Marys Medical Park Pharmacy	NDA	Current
60760-340	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	St Marys Medical Park Pharmacy	NDA	Current
60760-341	LEVOTHYROXINE SODIUM	LLEVOTHYROXINE SODIUM	St Marys Medical Park Pharmacy	NDA	Current
60760-342	Levothyroxine Sodium	Levothyroxine Sodium	St Marys Medical Park Pharmacy	NDA	Current
60760-343	Levothyroxine Sodium	Levothyroxine Sodium	St Marys Medical Park Pharmacy	NDA	Current
60760-345	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	St Marys Medical Park Pharmacy	NDA	Current
60760-346	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	St Marys Medical Park Pharmacy	NDA	Current
60846-801	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-801	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-801	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-801	Unithroid	levothyroxine sodium	Gemini Laboratories, LLC	NDA	Current
60846-802	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-802	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-802	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-802	Unithroid	levothyroxine sodium	Gemini Laboratories, LLC	NDA	Current
60846-803	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-803	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-803	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-803	Unithroid	levothyroxine sodium	Gemini Laboratories, LLC	NDA	Current
60846-804	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-804	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-804	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-804	Unithroid	levothyroxine sodium	Gemini Laboratories, LLC	NDA	Current
60846-805	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-805	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-805	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-805	Unithroid	levothyroxine sodium	Gemini Laboratories, LLC	NDA	Current
60846-806	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-806	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-806	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-806	Unithroid	levothyroxine sodium	Gemini Laboratories, LLC	NDA	Current
60846-807	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-807	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-807	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-807	Unithroid	levothyroxine sodium	Gemini Laboratories, LLC	NDA	Current
60846-808	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-808	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-808	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-808	Unithroid	levothyroxine sodium	Gemini Laboratories, LLC	NDA	Current
60846-809	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-809	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-809	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-809	Unithroid	levothyroxine sodium	Gemini Laboratories, LLC	NDA	Current
60846-810	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-810	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-810	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-810	Unithroid	levothyroxine sodium	Gemini Laboratories, LLC	NDA	Current
60846-811	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-811	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-811	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-811	Unithroid	levothyroxine sodium	Gemini Laboratories, LLC	NDA	Current
60846-812	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current
60846-812	Unithroid	levothyroxine sodium	Amneal Pharmaceuticals LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56834	SUPPL	2018-12-20
56720	SUPPL	2018-12-12
21510	SUPPL	2011-02-15
44106	ORIG	2009-05-30
36360	SUPPL	2008-02-14
27077	SUPPL	2008-02-14
21509	SUPPL	2005-05-13
21508	SUPPL	2005-05-13
4644	SUPPL	2004-12-22
27076	SUPPL	2004-06-24
42031	ORIG	2000-08-21
27075	ORIG	2000-08-21
14639	ORIG	2000-08-21