Levothyroxine Sodium

Product NDC: 50090-5654
Requested package NDC: 50090-5654-0
11-digit product format: 500905654
Labeler code: 50090
Product ID: 50090-5654_31419b67-68b7-409c-95e6-82ea3aaabbfc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levothyroxine Sodium
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA021342
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2020-08-03
Substance: LEVOTHYROXINE SODIUM
Active strength: 100 ug/1
Pharmacologic classes: Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 9 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
2025-04-01 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	Approval date
N021342-001	LEVO-T	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-002	LEVO-T	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-003	LEVO-T	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-004	LEVO-T	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-005	LEVO-T	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-006	LEVO-T	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-007	LEVO-T	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-008	LEVO-T	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-009	LEVO-T	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-010	LEVO-T	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-011	LEVO-T	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01
N021342-012	LEVO-T	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2003-12-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021342-001	AB1
N021342-001	AB2
N021342-001	AB3
N021342-002	AB1
N021342-002	AB2
N021342-002	AB3
N021342-003	AB1
N021342-003	AB2
N021342-003	AB3
N021342-004	AB1
N021342-004	AB2
N021342-004	AB3
N021342-005	AB1
N021342-005	AB2
N021342-005	AB3
N021342-006	AB1
N021342-006	AB2
N021342-006	AB3
N021342-007	AB1
N021342-007	AB2
N021342-007	AB3
N021342-008	AB1
N021342-008	AB2
N021342-008	AB3
N021342-009	AB1
N021342-009	AB2
N021342-009	AB3
N021342-010	AB1
N021342-010	AB2
N021342-010	AB3
N021342-011	AB1
N021342-011	AB2
N021342-011	AB3
N021342-012	AB1
N021342-012	AB2
N021342-012	AB3

Observed Orange Book product history#

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

Product history page 1 of 13 · 492 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021342-001	LEVO-T	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-002	LEVO-T	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-003	LEVO-T	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-004	LEVO-T	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-005	LEVO-T	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-006	LEVO-T	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-007	LEVO-T	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-008	LEVO-T	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-009	LEVO-T	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-010	LEVO-T	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-011	LEVO-T	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-012	LEVO-T	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2003-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021342-001	LEVO-T	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021342-002	LEVO-T	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021342-003	LEVO-T	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021342-004	LEVO-T	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021342-005	LEVO-T	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021342-006	LEVO-T	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021342-007	LEVO-T	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021342-008	LEVO-T	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021342-009	LEVO-T	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021342-010	LEVO-T	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021342-011	LEVO-T	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021342-012	LEVO-T	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2003-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021342-001	LEVO-T	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021342-002	LEVO-T	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021342-003	LEVO-T	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021342-004	LEVO-T	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021342-005	LEVO-T	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021342-006	LEVO-T	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021342-007	LEVO-T	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021342-008	LEVO-T	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021342-009	LEVO-T	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021342-010	LEVO-T	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021342-011	LEVO-T	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021342-012	LEVO-T	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2003-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021342-001	LEVO-T	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021342-002	LEVO-T	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021342-003	LEVO-T	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021342-004	LEVO-T	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2002-03-01	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 37 · 1,476 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	N021342-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-001	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-001	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-002	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-002	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-003	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-003	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-004	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-004	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-004	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-005	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-005	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-005	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-006	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-006	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-006	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-007	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-007	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-007	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-008	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-008	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-008	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-009	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-009	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-009	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-010	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-010	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-010	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-011	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-011	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-011	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-012	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-012	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021342-012	AB3	3	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021342-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021342-001	AB2	2	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021342-001	AB3	3	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021342-002	AB1	1	`31067a03dcf5…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021342-001	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-002	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-003	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-004	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-005	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-006	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-007	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-008	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-009	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-010	6399101	2020-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021342-011	6399101	2020-03-30	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021342-001	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-002	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-003	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-004	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-005	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-006	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-007	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-008	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-009	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-010	6399101	2020-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021342-011	6399101	2020-03-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021342-001	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-002	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-003	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-004	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-005	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-006	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-007	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-008	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-009	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-010	6399101	2020-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021342-011	6399101	2020-03-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021342-001	6399101	2020-03-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021342-002	6399101	2020-03-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021342-003	6399101	2020-03-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021342-004	6399101	2020-03-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021342-005	6399101	2020-03-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021342-006	6399101	2020-03-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021342-007	6399101	2020-03-30	`3f01610625f2…`

Additional Listing Data#

Finished product: Yes
Brand name base: Levothyroxine Sodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVOTHYROXINE SODIUM	100 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
892246	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
237cc591-c40b-416f-ac00-96cd61bc59dc	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
50090-5654-0	2023-02-06	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
50090-5654-1	2023-02-06	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
50090-5654-0	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
50090-5654-1	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
50090-5654-0	Levothyroxine Sodium	30 in 1 BOTTLE	TABLET	30		10
50090-5654-1	Levothyroxine Sodium	90 in 1 BOTTLE	TABLET	90		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5654-0	EA - Each	50090-5654	8a5aaf35-f8fa-4109-88b2-0ec0445aaa0d	1	2022-10-06
50090-5654-1	EA - Each	50090-5654	ae6b0f21-5d19-4a5c-964c-adcd066178bf	1	2022-10-06

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 3 · 48 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	489ffba8-983e-478f-8f62-fe08bf3d0e0b	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	5852d874-1ebc-49ff-b6c2-1dd513fca784	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	db5cba81-9ad5-42ad-ac9e-a967337630f2	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	d9ccea69-109d-44cf-927b-4ff67652b6a0	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	50978a14-fd72-4c76-927f-667a1f097b87	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	e293dd94-b523-47a2-8bed-e6d99945ee59	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	776c8dbc-ca34-40f9-9730-4aa59f644703	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	5c1cf991-6177-499d-a9b8-63e5ca92eb79	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	3142571d-f253-45e7-adc1-6ca80d34cab1	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	513d066a-2fcc-44ad-80e1-23c339a56ac6	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	1aaa327d-bb10-4815-8bd3-d8c9edc6c9db	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	64a663ac-ac02-4325-8f21-ee212e546121	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	4caf9040-5507-45a4-8f42-231aa925ab8d	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	0210a600-747e-433a-8ba9-11692ecfb54a	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	ef7bc627-d37b-470e-b8f7-3c472c930d05	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	d0beda93-9454-4846-b5c6-2a9113fb1765	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	0b9d21d8-9b49-4fd2-b516-b25bc6a6b671	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	caf7825d-f434-472f-94f3-217a41255562	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	73c3d459-dcbf-4458-8edd-2637275a96a1	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	4461bc9f-35db-4211-82ab-7671cf4dc14b	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021342 application number: NDA021342

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
892246	levothyroxine sodium 100 MCG Oral Tablet	PSN	237cc591-c40b-416f-ac00-96cd61bc59dc	10
892246	levothyroxine sodium 0.1 MG Oral Tablet	SCD	237cc591-c40b-416f-ac00-96cd61bc59dc	10
892246	levothyroxine sodium 100 MCG Oral Tablet	SY	237cc591-c40b-416f-ac00-96cd61bc59dc	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5654-0	50090565400	30 TABLET in 1 BOTTLE (50090-5654-0)	30 tablet	2021-09-13	0000-00-00	No	No	Current