levothyroxine sodium

Product NDC: 50090-4799
Requested package NDC: 50090-4799-0
11-digit product format: 500904799
Labeler code: 50090
Product ID: 50090-4799_f2ee3fc5-4e2b-4b13-bd7c-7cbbf520ac1f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levothyroxine sodium
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA021116
Marketing category: NDA
Marketing start: 2019-05-07
Substance: LEVOTHYROXINE SODIUM
Active strength: 125 ug/1
Pharmacologic classes: Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24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 · 492 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
2026-02-19 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…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	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	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	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	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	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	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	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	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 43 · 1,716 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	N021116-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-001	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-001	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-001	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-002	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-002	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-002	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-003	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-003	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-003	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-004	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-004	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-004	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-004	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-005	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-005	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-005	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-005	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-006	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-006	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-006	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-006	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-007	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-007	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-007	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-007	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-008	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-008	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-008	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-008	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-009	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-009	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-009	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-009	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-010	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-010	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-010	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-010	AB4	4	`011fe1cb6892…`

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	125 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9J765S329G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
966224	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8f7dc71e-4a48-4ba5-945b-f340ff51636e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
97c252d3-9bb8-4530-bb44-9824dc7cf556	Product name	6	20250729
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
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
6a33ec05-2ae2-45e5-ab82-2d94b3303923	Product name	1	20190709
93355a10-1c44-4c92-a11d-7d995e0200d9	Product name	1	20190219

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-4799-0	2023-02-07	These highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002
50090-4799-1	2023-02-07	These highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002
50090-4799-0	2023-01-30	These highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002
50090-4799-1	2023-01-30	These highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4799-0	levothyroxine sodium	30 in 1 BOTTLE	TABLET	30		11
50090-4799-1	levothyroxine sodium	90 in 1 BOTTLE	TABLET	90		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4799-0	EA - Each	50090-4799	c86c571f-2481-4586-aabf-263107f5d186	1	2026-03-17
50090-4799-1	EA - Each	50090-4799	778fbd01-4696-43cc-b948-5356e5606e28	1	2021-08-05

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 2 · 33 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	3b282e57-1009-4d2c-8ca2-9cca9f791937	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	eb53dc23-8337-497e-b466-192f905563ed	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	3519c765-2077-4f23-8644-a6242ddbf743	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	ac10b751-5195-4987-a841-400ae79730f0	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	645c52bb-c46e-426e-91d4-151aeac975a7	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	65c8b305-8ffb-4aa5-aca1-f4e4ead71a9c	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	f2bed4e7-86e9-430e-80d9-7bd7cfcf9bf5	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	8f7dc71e-4a48-4ba5-945b-f340ff51636e	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116 ndc (package): 50090-4799-0 ndc (product): 50090-4799 ndc11 (package): 50090479900
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	59a99739-2da5-46a7-8811-1169123bed9b	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	579b1935-77f5-4381-9cb0-e0130e4834e8	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	4e6dce46-cbf5-4353-9d0c-36b6f857197a	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	db5dd9d2-4f96-25d0-e053-2995a90af9dc	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	c9f4923e-5625-1d4f-e053-2a95a90aabc9	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	db89c58f-9dd0-b6d6-e053-2a95a90ae2e7	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	48c29432-a36c-4787-a05f-8d25a0abcc37	2025-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	00a4fc0b-7162-455e-8ed3-56efdbbe182e	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	c1b0fbad-5816-4152-ab59-05079e8c2148	2025-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	9e3bffb9-f66e-4c73-befc-e60d769f6610	2025-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	398a00d0-1247-4f6f-b4c1-dade399cc417	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	412fc3f4-d9e0-49c5-b042-a6010aea7e5e	2025-07-14	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
966224	levothyroxine sodium 125 MCG Oral Tablet	PSN	8f7dc71e-4a48-4ba5-945b-f340ff51636e	11
966224	levothyroxine sodium 0.125 MG Oral Tablet	SCD	8f7dc71e-4a48-4ba5-945b-f340ff51636e	11
966224	levothyroxine sodium 125 MCG Oral Tablet	SY	8f7dc71e-4a48-4ba5-945b-f340ff51636e	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4799-0	50090479900	30 TABLET in 1 BOTTLE (50090-4799-0)	30 tablet	2019-12-16	0000-00-00	No	No	Current