levothyroxine sodium

Product NDC: 47781-643
11-digit product format: 477810643
Labeler code: 47781
Product ID: 47781-643_3b8c38aa-ac99-1c0d-42f3-4fe8881125dc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levothyroxine sodium
Dosage form: TABLET
Route: ORAL
Labeler: Alvogen, Inc.
Application: NDA021116
Marketing category: NDA
Marketing start: 2019-05-07
Substance: LEVOTHYROXINE SODIUM
Active strength: 50 ug/1
Pharmacologic classes: Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
N021116-001	THYRO-TABS	LEVOTHYROXINE SODIUM	0.025MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24
N021116-002	THYRO-TABS	LEVOTHYROXINE SODIUM	0.05MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24
N021116-003	THYRO-TABS	LEVOTHYROXINE SODIUM	0.075MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24
N021116-004	THYRO-TABS	LEVOTHYROXINE SODIUM	0.1MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24
N021116-005	THYRO-TABS	LEVOTHYROXINE SODIUM	0.125MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24
N021116-006	THYRO-TABS	LEVOTHYROXINE SODIUM	0.15MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24
N021116-007	THYRO-TABS	LEVOTHYROXINE SODIUM	0.175MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24
N021116-008	THYRO-TABS	LEVOTHYROXINE SODIUM	0.2MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24
N021116-009	THYRO-TABS	LEVOTHYROXINE SODIUM	0.3MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24
N021116-010	THYRO-TABS	LEVOTHYROXINE SODIUM	0.088MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24
N021116-011	THYRO-TABS	LEVOTHYROXINE SODIUM	0.112MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24
N021116-012	THYRO-TABS	LEVOTHYROXINE SODIUM	0.137MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2004-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021116-001	AB1
N021116-001	AB2
N021116-001	AB3
N021116-001	AB4
N021116-002	AB1
N021116-002	AB2
N021116-002	AB3
N021116-002	AB4
N021116-003	AB1
N021116-003	AB2
N021116-003	AB3
N021116-003	AB4
N021116-004	AB1
N021116-004	AB2
N021116-004	AB3
N021116-004	AB4
N021116-005	AB1
N021116-005	AB2
N021116-005	AB3
N021116-005	AB4
N021116-006	AB1
N021116-006	AB2
N021116-006	AB3
N021116-006	AB4
N021116-007	AB1
N021116-007	AB2
N021116-007	AB3
N021116-007	AB4
N021116-008	AB1
N021116-008	AB2
N021116-008	AB3
N021116-008	AB4
N021116-009	AB1
N021116-009	AB2
N021116-009	AB3
N021116-009	AB4
N021116-010	AB1
N021116-010	AB2
N021116-010	AB3
N021116-010	AB4
N021116-011	AB1
N021116-011	AB2
N021116-011	AB3
N021116-011	AB4
N021116-012	AB1
N021116-012	AB2
N021116-012	AB3
N021116-012	AB4

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 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	N021116-001	THYRO-TABS	0.025MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-002	THYRO-TABS	0.05MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-003	THYRO-TABS	0.075MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-004	THYRO-TABS	0.1MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-005	THYRO-TABS	0.125MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-006	THYRO-TABS	0.15MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-007	THYRO-TABS	0.175MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-008	THYRO-TABS	0.2MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-009	THYRO-TABS	0.3MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-010	THYRO-TABS	0.088MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-011	THYRO-TABS	0.112MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-012	THYRO-TABS	0.137MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2004-12-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021116-001	THYRO-TABS	0.025MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021116-002	THYRO-TABS	0.05MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021116-003	THYRO-TABS	0.075MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021116-004	THYRO-TABS	0.1MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021116-005	THYRO-TABS	0.125MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021116-006	THYRO-TABS	0.15MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021116-007	THYRO-TABS	0.175MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021116-008	THYRO-TABS	0.2MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021116-009	THYRO-TABS	0.3MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021116-010	THYRO-TABS	0.088MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021116-011	THYRO-TABS	0.112MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021116-012	THYRO-TABS	0.137MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2004-12-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021116-001	THYRO-TABS	0.025MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-002	THYRO-TABS	0.05MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-003	THYRO-TABS	0.075MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-004	THYRO-TABS	0.1MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-005	THYRO-TABS	0.125MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-006	THYRO-TABS	0.15MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-007	THYRO-TABS	0.175MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-008	THYRO-TABS	0.2MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-009	THYRO-TABS	0.3MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-010	THYRO-TABS	0.088MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-011	THYRO-TABS	0.112MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-012	THYRO-TABS	0.137MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2004-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021116-001	THYRO-TABS	0.025MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021116-002	THYRO-TABS	0.05MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021116-003	THYRO-TABS	0.075MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021116-004	THYRO-TABS	0.1MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 46 · 1,812 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	N021116-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-001	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-001	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-001	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-002	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-002	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-002	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-003	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-003	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-003	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-004	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-004	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-004	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-004	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-005	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-005	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-005	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-005	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-006	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-006	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-006	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-006	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-007	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-007	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-007	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-007	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-008	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-008	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-008	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-008	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-009	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-009	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-009	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-009	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-010	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-010	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-010	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-010	AB4	4	`84e616aacf4f…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: levothyroxine sodium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVOTHYROXINE SODIUM	50 ug/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
97c252d3-9bb8-4530-bb44-9824dc7cf556	Product name	6	20250729
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
6c43b71c-35e6-4db3-ba24-c6ef42ff7003	Product name	3	20240207
890fd4bf-1a80-42b7-be1b-2d0259d5f0c8	Product name	5	20240207
c8ad26bf-af73-460b-b74e-1eff16cc4f9f	Product name	5	20240207
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
01383843-4069-43cf-aa76-dc17a6f9f8c4	Product name	2	20230123
978cca7d-a938-4791-8322-da48d90a63ef	Product name	1	20230113
65f86ba3-8816-4e12-899b-18290c8de551	Product name	2	20210614
f16ab90f-08c2-40be-a543-66d9827cd1f3	Product name	1	20210601
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
6a33ec05-2ae2-45e5-ab82-2d94b3303923	Product name	1	20190709
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
93355a10-1c44-4c92-a11d-7d995e0200d9	Product name	1	20190219
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
47781-643-10	levothyroxine sodium	1000 in 1 BOTTLE	TABLET	1000		7
47781-643-90	levothyroxine sodium	90 in 1 BOTTLE	TABLET	90		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47781-643-10	EA - Each	47781-643	5a0f4aaf-2723-449b-bf5f-92d1bca6b73b	1	2019-06-19
47781-643-90	EA - Each	47781-643	500796fd-6b3d-4c58-ab73-97148a0686f2	1	2019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47781-643	LEVOTHYROXINE SODIUM TABLET [ALVOGEN, INC.]	6	Current NDC, Legacy NDC, 2 package rows	20240317_4ddcaec1-a58f-340b-9bc1-bbe048b8c885.zip

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 2 · 32 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	fc803107-aaa2-4753-ab97-7b4ed5cf4be5	2025-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	d79526e0-d327-4545-a50c-99678766d817	2024-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	c22af2e0-fb36-4645-a911-3d293af5bd88	2024-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals,Inc.	a2157cf0-5c8f-7e69-e053-2a95a90aa083	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals,Inc.	a215da96-acd9-6b8d-e053-2995a90a7e0d	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	NuCar Pharmaceuticals,Inc.	a2194c58-b755-e6b5-e053-2a95a90a36d4	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	DIRECT RX	a5f15022-1166-09fe-e053-2a95a90aa218	2024-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	8849620a-5e8d-4031-884f-9a2817b050f2	2024-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	d35b5250-c26d-4d67-8a33-2f993b13e3e9	2024-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	2daab9ce-0570-4fdf-a7bd-01c3178f8cf3	2021-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	12ccf2fd-ccf0-4bcf-8eee-e2a16c8b44d6	2020-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	3019762c-d480-4530-a3b2-762b523e7961	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9J765S329G	LEVOTHYROXINE SODIUM	6106-07-6	LEVOTHYROXINE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
966221	levothyroxine sodium 50 MCG Oral Tablet	PSN	c22af2e0-fb36-4645-a911-3d293af5bd88	105
966221	levothyroxine sodium 0.05 MG Oral Tablet	SCD	c22af2e0-fb36-4645-a911-3d293af5bd88	105
966221	levothyroxine sodium 50 MCG Oral Tablet	SY	c22af2e0-fb36-4645-a911-3d293af5bd88	105
966221	levothyroxine sodium 50 MCG Oral Tablet	PSN	c1b0fbad-5816-4152-ab59-05079e8c2148	102
966221	levothyroxine sodium 0.05 MG Oral Tablet	SCD	c1b0fbad-5816-4152-ab59-05079e8c2148	102
966221	levothyroxine sodium 50 MCG Oral Tablet	SY	c1b0fbad-5816-4152-ab59-05079e8c2148	102
892246	levothyroxine sodium 100 MCG Oral Tablet	PSN	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966248	levothyroxine sodium 112 MCG Oral Tablet	PSN	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966224	levothyroxine sodium 125 MCG Oral Tablet	PSN	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966270	levothyroxine sodium 137 MCG Oral Tablet	PSN	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966225	levothyroxine sodium 150 MCG Oral Tablet	PSN	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966249	levothyroxine sodium 175 MCG Oral Tablet	PSN	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
892251	levothyroxine sodium 200 MCG Oral Tablet	PSN	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966220	levothyroxine sodium 25 MCG Oral Tablet	PSN	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966221	levothyroxine sodium 50 MCG Oral Tablet	PSN	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966222	levothyroxine sodium 75 MCG Oral Tablet	PSN	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966253	levothyroxine sodium 88 MCG Oral Tablet	PSN	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966220	levothyroxine sodium 0.025 MG Oral Tablet	SCD	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966221	levothyroxine sodium 0.05 MG Oral Tablet	SCD	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966222	levothyroxine sodium 0.075 MG Oral Tablet	SCD	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966253	levothyroxine sodium 0.088 MG Oral Tablet	SCD	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
892246	levothyroxine sodium 0.1 MG Oral Tablet	SCD	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966248	levothyroxine sodium 0.112 MG Oral Tablet	SCD	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966224	levothyroxine sodium 0.125 MG Oral Tablet	SCD	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966270	levothyroxine sodium 0.137 MG Oral Tablet	SCD	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966225	levothyroxine sodium 0.15 MG Oral Tablet	SCD	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966249	levothyroxine sodium 0.175 MG Oral Tablet	SCD	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
892251	levothyroxine sodium 0.2 MG Oral Tablet	SCD	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
892246	levothyroxine sodium 100 MCG Oral Tablet	SY	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966248	levothyroxine sodium 112 MCG Oral Tablet	SY	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966224	levothyroxine sodium 125 MCG Oral Tablet	SY	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966270	levothyroxine sodium 137 MCG Oral Tablet	SY	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966225	levothyroxine sodium 150 MCG Oral Tablet	SY	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966249	levothyroxine sodium 175 MCG Oral Tablet	SY	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
892251	levothyroxine sodium 200 MCG Oral Tablet	SY	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966220	levothyroxine sodium 25 MCG Oral Tablet	SY	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966221	levothyroxine sodium 50 MCG Oral Tablet	SY	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966222	levothyroxine sodium 75 MCG Oral Tablet	SY	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
966253	levothyroxine sodium 88 MCG Oral Tablet	SY	9e3bffb9-f66e-4c73-befc-e60d769f6610	26
892246	levothyroxine sodium 100 MCG Oral Tablet	PSN	a5f15022-1166-09fe-e053-2a95a90aa218	21
966248	levothyroxine sodium 112 MCG Oral Tablet	PSN	a5f15022-1166-09fe-e053-2a95a90aa218	21
966224	levothyroxine sodium 125 MCG Oral Tablet	PSN	a5f15022-1166-09fe-e053-2a95a90aa218	21
966270	levothyroxine sodium 137 MCG Oral Tablet	PSN	a5f15022-1166-09fe-e053-2a95a90aa218	21
966225	levothyroxine sodium 150 MCG Oral Tablet	PSN	a5f15022-1166-09fe-e053-2a95a90aa218	21
966220	levothyroxine sodium 25 MCG Oral Tablet	PSN	a5f15022-1166-09fe-e053-2a95a90aa218	21
966221	levothyroxine sodium 50 MCG Oral Tablet	PSN	a5f15022-1166-09fe-e053-2a95a90aa218	21
966222	levothyroxine sodium 75 MCG Oral Tablet	PSN	a5f15022-1166-09fe-e053-2a95a90aa218	21
966253	levothyroxine sodium 88 MCG Oral Tablet	PSN	a5f15022-1166-09fe-e053-2a95a90aa218	21
966220	levothyroxine sodium 0.025 MG Oral Tablet	SCD	a5f15022-1166-09fe-e053-2a95a90aa218	21
966221	levothyroxine sodium 0.05 MG Oral Tablet	SCD	a5f15022-1166-09fe-e053-2a95a90aa218	21
966222	levothyroxine sodium 0.075 MG Oral Tablet	SCD	a5f15022-1166-09fe-e053-2a95a90aa218	21
966253	levothyroxine sodium 0.088 MG Oral Tablet	SCD	a5f15022-1166-09fe-e053-2a95a90aa218	21
892246	levothyroxine sodium 0.1 MG Oral Tablet	SCD	a5f15022-1166-09fe-e053-2a95a90aa218	21
966248	levothyroxine sodium 0.112 MG Oral Tablet	SCD	a5f15022-1166-09fe-e053-2a95a90aa218	21
966224	levothyroxine sodium 0.125 MG Oral Tablet	SCD	a5f15022-1166-09fe-e053-2a95a90aa218	21
966270	levothyroxine sodium 0.137 MG Oral Tablet	SCD	a5f15022-1166-09fe-e053-2a95a90aa218	21
966225	levothyroxine sodium 0.15 MG Oral Tablet	SCD	a5f15022-1166-09fe-e053-2a95a90aa218	21
892246	levothyroxine sodium 100 MCG Oral Tablet	SY	a5f15022-1166-09fe-e053-2a95a90aa218	21
966248	levothyroxine sodium 112 MCG Oral Tablet	SY	a5f15022-1166-09fe-e053-2a95a90aa218	21
966224	levothyroxine sodium 125 MCG Oral Tablet	SY	a5f15022-1166-09fe-e053-2a95a90aa218	21
966270	levothyroxine sodium 137 MCG Oral Tablet	SY	a5f15022-1166-09fe-e053-2a95a90aa218	21
966225	levothyroxine sodium 150 MCG Oral Tablet	SY	a5f15022-1166-09fe-e053-2a95a90aa218	21
966220	levothyroxine sodium 25 MCG Oral Tablet	SY	a5f15022-1166-09fe-e053-2a95a90aa218	21
966221	levothyroxine sodium 50 MCG Oral Tablet	SY	a5f15022-1166-09fe-e053-2a95a90aa218	21
966222	levothyroxine sodium 75 MCG Oral Tablet	SY	a5f15022-1166-09fe-e053-2a95a90aa218	21
966253	levothyroxine sodium 88 MCG Oral Tablet	SY	a5f15022-1166-09fe-e053-2a95a90aa218	21
892246	levothyroxine sodium 100 MCG Oral Tablet	PSN	4ddcaec1-a58f-340b-9bc1-bbe048b8c885	7
966248	levothyroxine sodium 112 MCG Oral Tablet	PSN	4ddcaec1-a58f-340b-9bc1-bbe048b8c885	7
966224	levothyroxine sodium 125 MCG Oral Tablet	PSN	4ddcaec1-a58f-340b-9bc1-bbe048b8c885	7
966270	levothyroxine sodium 137 MCG Oral Tablet	PSN	4ddcaec1-a58f-340b-9bc1-bbe048b8c885	7
966225	levothyroxine sodium 150 MCG Oral Tablet	PSN	4ddcaec1-a58f-340b-9bc1-bbe048b8c885	7
966249	levothyroxine sodium 175 MCG Oral Tablet	PSN	4ddcaec1-a58f-340b-9bc1-bbe048b8c885	7
892251	levothyroxine sodium 200 MCG Oral Tablet	PSN	4ddcaec1-a58f-340b-9bc1-bbe048b8c885	7
966220	levothyroxine sodium 25 MCG Oral Tablet	PSN	4ddcaec1-a58f-340b-9bc1-bbe048b8c885	7
892255	levothyroxine sodium 300 MCG Oral Tablet	PSN	4ddcaec1-a58f-340b-9bc1-bbe048b8c885	7
966221	levothyroxine sodium 50 MCG Oral Tablet	PSN	4ddcaec1-a58f-340b-9bc1-bbe048b8c885	7
966222	levothyroxine sodium 75 MCG Oral Tablet	PSN	4ddcaec1-a58f-340b-9bc1-bbe048b8c885	7
966253	levothyroxine sodium 88 MCG Oral Tablet	PSN	4ddcaec1-a58f-340b-9bc1-bbe048b8c885	7
966220	levothyroxine sodium 0.025 MG Oral Tablet	SCD	4ddcaec1-a58f-340b-9bc1-bbe048b8c885	7
966221	levothyroxine sodium 0.05 MG Oral Tablet	SCD	4ddcaec1-a58f-340b-9bc1-bbe048b8c885	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47781-643-10	47781064310	1000 TABLET in 1 BOTTLE (47781-643-10)	1000 tablet	2019-05-07	0000-00-00	No	No	Current
47781-643-90	47781064390	90 TABLET in 1 BOTTLE (47781-643-90)	90 tablet	2019-05-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
levothyroxine sodium	Alvogen, Inc.	2026-09-15	HUMAN PRESCRIPTION DRUG LABEL	10
levothyroxine sodium	Preferred Pharmaceuticals, Inc.	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	6
levothyroxine sodium	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
levothyroxine sodium	Bryant Ranch Prepack	2025-07-29	HUMAN PRESCRIPTION DRUG LABEL	102
levothyroxine sodium	Bryant Ranch Prepack	2025-07-29	HUMAN PRESCRIPTION DRUG LABEL	26
levothyroxine sodium	Bryant Ranch Prepack	2024-08-21	HUMAN PRESCRIPTION DRUG LABEL	100
levothyroxine sodium	Bryant Ranch Prepack	2024-08-06	HUMAN PRESCRIPTION DRUG LABEL	105
levothyroxine sodium	NuCare Pharmaceuticals,Inc.	2024-06-20	HUMAN PRESCRIPTION DRUG LABEL	3
LEVOTHYROXINE SODIUM	DIRECT RX	2024-05-23	HUMAN PRESCRIPTION DRUG LABEL	21
levothyroxine sodium	A-S Medication Solutions	2023-02-06	HUMAN PRESCRIPTION DRUG LABEL	8
levothyroxine sodium	PD-Rx Pharmaceuticals, Inc.	2022-05-27	HUMAN PRESCRIPTION DRUG LABEL	10
levothyroxine sodium	REMEDYREPACK INC.	2022-01-31	HUMAN PRESCRIPTION DRUG LABEL	4
levothyroxine sodium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-06-24	HUMAN PRESCRIPTION DRUG LABEL	1
levothyroxine sodium	A-S Medication Solutions	2021-01-14	HUMAN PRESCRIPTION DRUG LABEL	1
levothyroxine sodium	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	1