levothyroxine sodium

Product NDC: 50090-4668
11-digit product format: 500904668
Labeler code: 50090
Product ID: 50090-4668_b0be5bec-3b38-46c2-93bb-12d9e9277f1a
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
Marketing end: 0000-00-00
Substance: LEVOTHYROXINE SODIUM
Active strength: 50 ug/1
Pharmacologic classes: l-Thyroxine [EPC],Thyroxine [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50090-4668		D	Discontinued by firm	2026-10-12
excluded package	package	50090-4668	50090-4668-0	D	Discontinued by firm	2026-10-12
excluded package	package	50090-4668	50090-4668-1	D	Discontinued by firm	2026-10-12

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-4668-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-4668-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-4668-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-4668-0	`f5e01cc5f278…`	`a2eaf40c39c3…`

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.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-4668-0	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
50090-4668-1	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
50090-4668-0	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
50090-4668-1	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4668-1	EA - Each	50090-4668	740ae092-a3e0-44bf-8a27-868d15cb91cb	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4668	LEVOTHYROXINE SODIUM TABLET [A-S MEDICATION SOLUTIONS]	8	Legacy NDC	20230208_674c4177-927c-41f8-9479-cfa2bfb23702.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4668-0	50090466800	30 TABLET in 1 BOTTLE (50090-4668-0)	30 tablet	2019-11-01	0000-00-00	No	No	Current
50090-4668-1	50090466801	90 TABLET in 1 BOTTLE (50090-4668-1)	90 tablet	2019-11-01	0000-00-00	No	No	Current