Levothyroxine sodium

Product NDC: 0781-5186
11-digit product format: 007815186
Labeler code: 0781
Product ID: 0781-5186_b6216747-5ffb-6cd7-e053-2995a90a5ca0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levothyroxine sodium
Dosage form: TABLET
Route: ORAL
Labeler: Sandoz Inc.
Application: NDA021342
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2002-03-01
Marketing end: 2021-12-31
Substance: LEVOTHYROXINE SODIUM
Active strength: 125 ug/1
Pharmacologic classes: l-Thyroxine [EPC],Thyroxine [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	0781-5186		D	Discontinued by firm	2026-08-03
excluded package	package	0781-5186	0781-5186-10	D	Discontinued by firm	2026-08-03
excluded package	package	0781-5186	0781-5186-92	D	Discontinued by firm	2026-08-03

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 · 36 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	0781-5186-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-5186-92	`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	0781-5186-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-5186-92	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-5186-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-5186-92	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-5186-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-5186-92	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-5186-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-5186-92	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-5186-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-5186-92	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-5186-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-5186-92	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-5186-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-5186-92	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-5186-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-5186-92	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0781-5186-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0781-5186-92	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0781-5186-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0781-5186-92	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0781-5186-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0781-5186-92	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-5186-01	EA - Each	0781-5186	9c899622-c6b5-4907-bc4d-5dc00ab6f99c	1	2012-07-24
0781-5186-10	EA - Each	0781-5186	0a2f28da-7c1b-4296-a534-60cd51a70564	1	2012-07-24
0781-5186-92	EA - Each	0781-5186	85b4aa37-3778-4088-9eae-ed36045238dd	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOTHYROXINE SODIUM	ACTIVE INGREDIENT	9J765S329G	LEVOTHYROXINE SODIUM TABLET [SANDOZ INC.]	11
LEVOTHYROXINE	ACTIVE MOIETY	Q51BO43MG4	LEVOTHYROXINE SODIUM TABLET [SANDOZ INC.]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOTHYROXINE SODIUM TABLET [SANDOZ INC.]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOTHYROXINE SODIUM TABLET [SANDOZ INC.]	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVOTHYROXINE SODIUM TABLET [SANDOZ INC.]	11
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LEVOTHYROXINE SODIUM TABLET [SANDOZ INC.]	11
LEVOTHYROXINE SODIUM	ACTIVE INGREDIENT	9J765S329G	LEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
LEVOTHYROXINE	ACTIVE MOIETY	Q51BO43MG4	LEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
LEVOTHYROXINE SODIUM	ACTIVE INGREDIENT	9J765S329G	LEVOTHYROXINE SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
LEVOTHYROXINE	ACTIVE MOIETY	Q51BO43MG4	LEVOTHYROXINE SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOTHYROXINE SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOTHYROXINE SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVOTHYROXINE SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LEVOTHYROXINE SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]	1

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
966224	levothyroxine sodium 125 MCG Oral Tablet	PSN	69de922e-931e-4723-a91f-0cd774f008d1	1
966224	levothyroxine sodium 0.125 MG Oral Tablet	SCD	69de922e-931e-4723-a91f-0cd774f008d1	1
966224	levothyroxine sodium 125 MCG Oral Tablet	SY	69de922e-931e-4723-a91f-0cd774f008d1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-5186-10	00781518610	1000 TABLET in 1 BOTTLE (0781-5186-10)	1000 tablet	2002-03-01	2021-12-31	No	No	Current
0781-5186-92	00781518692	90 TABLET in 1 BOTTLE (0781-5186-92)	90 tablet	2012-04-16	2021-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levothyroxine sodium	Preferred Pharmaceuticals, Inc.	2021-06-30	HUMAN PRESCRIPTION DRUG LABEL	8
Levothyroxine sodium	NuCare Pharmaceuticals,Inc.	2021-03-17	HUMAN PRESCRIPTION DRUG LABEL	4
Levothyroxine sodium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-12-30	HUMAN PRESCRIPTION DRUG LABEL	2
Levothyroxine sodium	Sandoz Inc. \| Neolpharma, Inc. \| Neolpharma, Inc \| Patheon Puerto Rico, Inc.	2020-12-15	HUMAN PRESCRIPTION DRUG LABEL	23
Levothyroxine sodium	Bryant Ranch Prepack	2020-09-20	HUMAN PRESCRIPTION DRUG LABEL	19
Levothyroxine sodium	Proficient Rx LP	2020-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
LEVOTHYROXINE SODIUM	Direct_Rx	2019-10-14	HUMAN PRESCRIPTION DRUG LABEL	2
Levothyroxine Sodium Tablets, USP	Aidarex Pharmaceuticals LLC	2014-01-08	HUMAN PRESCRIPTION DRUG LABEL	1