Levothyroxine Sodium

Product NDC: 53808-0605
11-digit product format: 538080605
Labeler code: 53808
Product ID: 53808-0605_feb3b39a-cb33-4b75-8ed9-a991ee25d31e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levothyroxine sodium
Dosage form: TABLET
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: ANDA076187
Marketing category: ANDA
Marketing start: 2009-07-01
Marketing end: 0000-00-00
Substance: LEVOTHYROXINE SODIUM
Active strength: 50 ug/1
Pharmacologic classes: l-Thyroxine [EPC],Thyroxine [CS]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53808-0605		I	Inactivated by FDA		2026-10-05
excluded package	package	53808-0605	53808-0605-1	I	Inactivated by FDA		2026-10-05

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53808-0605-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53808-0605-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53808-0605-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53808-0605-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53808-0605-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53808-0605-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53808-0605-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53808-0605-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53808-0605-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53808-0605-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53808-0605-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53808-0605-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53808-0605-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53808-0605-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53808-0605-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53808-0605-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53808-0605-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53808-0605-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53808-0605-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53808-0605-1	E	Excluded after deficient or non-compliant submission was not corrected	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53808-0605-1	E	Excluded after deficient or non-compliant submission was not corrected	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53808-0605-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A076187-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-004	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-005	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-006	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-007	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-008	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-009	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-010	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-011	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	RS	2002-06-05
A076187-012	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2006-12-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076187-001	AB1
A076187-001	AB2
A076187-001	AB3
A076187-001	AB4
A076187-002	AB1
A076187-002	AB2
A076187-002	AB3
A076187-002	AB4
A076187-003	AB1
A076187-003	AB2
A076187-003	AB3
A076187-003	AB4
A076187-004	AB1
A076187-004	AB2
A076187-004	AB3
A076187-004	AB4
A076187-005	AB1
A076187-005	AB2
A076187-005	AB3
A076187-005	AB4
A076187-006	AB1
A076187-006	AB2
A076187-006	AB3
A076187-006	AB4
A076187-007	AB1
A076187-007	AB2
A076187-007	AB3
A076187-007	AB4
A076187-008	AB1
A076187-008	AB2
A076187-008	AB3
A076187-008	AB4
A076187-009	AB1
A076187-009	AB2
A076187-009	AB3
A076187-009	AB4
A076187-010	AB1
A076187-010	AB2
A076187-010	AB3
A076187-010	AB4
A076187-011	AB1
A076187-011	AB2
A076187-011	AB3
A076187-011	AB4
A076187-012	AB1
A076187-012	AB2
A076187-012	AB3
A076187-012	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	A076187-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-008	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-009	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-010	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-011	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	RS	2002-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-012	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2006-12-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076187-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076187-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076187-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076187-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076187-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076187-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076187-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076187-008	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076187-009	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076187-010	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076187-011	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	RS	2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076187-012	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2006-12-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076187-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-008	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-009	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-010	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-011	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	RS	2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-012	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2006-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 52 · 2,064 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	A076187-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-001	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-001	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-001	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-002	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-002	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-002	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-003	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-003	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-003	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-004	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-004	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-004	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-004	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-005	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-005	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-005	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-005	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-006	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-006	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-006	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-006	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-007	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-007	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-007	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-007	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-008	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-008	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-008	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-008	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-009	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-009	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-009	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-009	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-010	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-010	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-010	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076187-010	AB4	4	`84e616aacf4f…`

Reported adverse events (FAERS/openFDA)#

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

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-0605-1	2021-01-29	C162847	48780-1	956f9ecf-ce8b-621f-e053-dbdaa90a74ad	b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0605-1	Levothyroxine Sodium	30 in 1 BLISTER PACK	TABLET	30		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOTHYROXINE SODIUM	ACTIVE INGREDIENT	9J765S329G	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
LEVOTHYROXINE	ACTIVE MOIETY	Q51BO43MG4	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-0605	LEVOTHYROXINE SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2	Legacy NDC, 1 package rows	20100824_b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4.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 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Cardinal Health 107, LLC	66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076187 application number: ANDA076187
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	db10e666-6204-56cc-e053-2995a90a9e08	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076187 application number: ANDA076187
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	fa15ac73-f4f6-7a6b-e053-6294a90a4f4e	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076187 application number: ANDA076187
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Mylan Institutional Inc.	cd69c192-cd3f-47e6-b0a6-c536ffed5c4b	2025-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076187 application number: ANDA076187
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Mylan Institutional Inc.	5723c7a7-2a1d-4ab6-bf39-b2165ae781a6	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076187 application number: ANDA076187
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Mylan Pharmaceuticals Inc.	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	2024-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076187 application number: ANDA076187

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	b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4	2
966224	levothyroxine sodium 125 MCG Oral Tablet	PSN	b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4	2
966225	levothyroxine sodium 150 MCG Oral Tablet	PSN	b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4	2
966249	levothyroxine sodium 175 MCG Oral Tablet	PSN	b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4	2
966220	levothyroxine sodium 25 MCG Oral Tablet	PSN	b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4	2
966221	levothyroxine sodium 50 MCG Oral Tablet	PSN	b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4	2
966222	levothyroxine sodium 75 MCG Oral Tablet	PSN	b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4	2
966220	levothyroxine sodium 0.025 MG Oral Tablet	SCD	b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4	2
966221	levothyroxine sodium 0.05 MG Oral Tablet	SCD	b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4	2
966222	levothyroxine sodium 0.075 MG Oral Tablet	SCD	b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4	2
892246	levothyroxine sodium 0.1 MG Oral Tablet	SCD	b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4	2
966224	levothyroxine sodium 0.125 MG Oral Tablet	SCD	b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4	2
966225	levothyroxine sodium 0.15 MG Oral Tablet	SCD	b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4	2
966249	levothyroxine sodium 0.175 MG Oral Tablet	SCD	b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4	2
892246	levothyroxine sodium 100 MCG Oral Tablet	SY	b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4	2
966224	levothyroxine sodium 125 MCG Oral Tablet	SY	b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4	2
966225	levothyroxine sodium 150 MCG Oral Tablet	SY	b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4	2
966249	levothyroxine sodium 175 MCG Oral Tablet	SY	b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4	2
966220	levothyroxine sodium 25 MCG Oral Tablet	SY	b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4	2
966221	levothyroxine sodium 50 MCG Oral Tablet	SY	b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4	2
966222	levothyroxine sodium 75 MCG Oral Tablet	SY	b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-0605-1	53808060501	30 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levothyroxine Sodium - State of Florida DOH Central Pharmacy	State of Florida DOH Central Pharmacy	2010-08-19	HUMAN PRESCRIPTION DRUG LABEL	2