Synthroid

Product NDC: 67544-887
11-digit product format: 675440887
Labeler code: 67544
Product ID: 67544-887_81f2d4c7-c121-42a1-81a2-902b8eda11cf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levothyroxine Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, Inc.
Application: NDA021402
Marketing category: NDA
Marketing start: 2002-07-24
Marketing end: 0000-00-00
Substance: LEVOTHYROXINE SODIUM
Active strength: 100 ug/1
Pharmacologic classes: l-Thyroxine [EPC],Thyroxine [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

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

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67544-887		I	Inactivated by FDA	2026-10-05
excluded package	package	67544-887	67544-887-30	I	Inactivated by FDA	2026-10-05
excluded package	package	67544-887	67544-887-60	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 2 · 66 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	67544-887-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-887-30	`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	67544-887-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-887-30	`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	67544-887-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-887-30	`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	67544-887-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-887-30	`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	67544-887-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-887-30	`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	67544-887-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-887-30	`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	67544-887-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67544-887-30	`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	67544-887-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67544-887-30	`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	67544-887-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67544-887-30	`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	67544-887-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67544-887-30	`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	67544-887-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67544-887-30	`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	67544-887-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67544-887-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67544-887-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67544-887-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67544-887-60	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67544-887-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67544-887-60	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67544-887-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67544-887-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67544-887-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67544-887-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67544-887-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67544-887-60	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67544-887-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67544-887-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67544-887-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67544-887-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67544-887-30	`e2bbac7714bc…`	`27bdfed8d636…`

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
N021402-001	SYNTHROID	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24
N021402-002	SYNTHROID	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24
N021402-003	SYNTHROID	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24
N021402-004	SYNTHROID	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24
N021402-005	SYNTHROID	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24
N021402-006	SYNTHROID	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24
N021402-007	SYNTHROID	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24
N021402-008	SYNTHROID	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24
N021402-009	SYNTHROID	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24
N021402-010	SYNTHROID	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24
N021402-011	SYNTHROID	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD, RS	2002-07-24
N021402-012	SYNTHROID	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 24 matching rows.

Application-product, TE code table
Application-product	TE code
N021402-001	AB1
N021402-001	AB2
N021402-002	AB1
N021402-002	AB2
N021402-003	AB1
N021402-003	AB2
N021402-004	AB1
N021402-004	AB2
N021402-005	AB1
N021402-005	AB2
N021402-006	AB1
N021402-006	AB2
N021402-007	AB1
N021402-007	AB2
N021402-008	AB1
N021402-008	AB2
N021402-009	AB1
N021402-009	AB2
N021402-010	AB1
N021402-010	AB2
N021402-011	AB1
N021402-011	AB2
N021402-012	AB1
N021402-012	AB2

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	N021402-001	SYNTHROID	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-002	SYNTHROID	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-003	SYNTHROID	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-004	SYNTHROID	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-005	SYNTHROID	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-006	SYNTHROID	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-007	SYNTHROID	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-008	SYNTHROID	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-009	SYNTHROID	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-010	SYNTHROID	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-011	SYNTHROID	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD, RS	2002-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-012	SYNTHROID	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021402-001	SYNTHROID	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-002	SYNTHROID	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-003	SYNTHROID	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-004	SYNTHROID	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-005	SYNTHROID	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-006	SYNTHROID	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-007	SYNTHROID	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-008	SYNTHROID	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-009	SYNTHROID	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-010	SYNTHROID	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-011	SYNTHROID	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD, RS	2002-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-012	SYNTHROID	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021402-001	SYNTHROID	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021402-002	SYNTHROID	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021402-003	SYNTHROID	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021402-004	SYNTHROID	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021402-005	SYNTHROID	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021402-006	SYNTHROID	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021402-007	SYNTHROID	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021402-008	SYNTHROID	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021402-009	SYNTHROID	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021402-010	SYNTHROID	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021402-011	SYNTHROID	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD, RS	2002-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021402-012	SYNTHROID	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021402-001	SYNTHROID	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021402-002	SYNTHROID	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021402-003	SYNTHROID	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021402-004	SYNTHROID	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 26 · 1,032 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	N021402-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-001	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-002	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-003	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-004	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-004	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-005	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-005	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-006	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-006	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-007	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-007	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-008	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-008	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-009	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-009	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-010	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-010	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-011	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-011	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-012	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-012	AB2	2	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021402-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-001	AB2	2	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-002	AB2	2	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-003	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-003	AB2	2	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-004	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-004	AB2	2	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-005	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-005	AB2	2	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-006	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-006	AB2	2	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-007	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-007	AB2	2	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-008	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-008	AB2	2	`caaa826d4ba7…`

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
67544-887-30	2019-11-13	C162847	48780-1	97449f38-ce27-f6ea-e053-dbdaa90aa703	SYNTHROID® (levothyroxine sodium tablets, USP)
67544-887-60	2019-11-13	C162847	48780-1	97449f38-ce27-f6ea-e053-dbdaa90aa703	SYNTHROID® (levothyroxine sodium tablets, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67544-887-30	Synthroid	30 in 1 BOTTLE, PLASTIC	TABLET	30		1
67544-887-60	Synthroid	90 in 1 BOTTLE, PLASTIC	TABLET	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67544-887-60	EA - Each	67544-887	eb1c7969-45ba-487e-ba15-9e87a13496d0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOTHYROXINE SODIUM	ACTIVE INGREDIENT	9J765S329G	SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
LEVOTHYROXINE	ACTIVE MOIETY	Q51BO43MG4	SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
ACACIA	INACTIVE INGREDIENT	5C5403N26O	SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67544-887	SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1	Legacy NDC, 2 package rows	20120323_5be7ee95-a27e-409d-881f-927f42074033.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Synthroid	LEVOTHYROXINE SODIUM	AbbVie Inc.	1e11ad30-1041-4520-10b0-8f9d30d30fcc	2024-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021402 application number: NDA021402

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	5be7ee95-a27e-409d-881f-927f42074033	1
966248	levothyroxine sodium 112 MCG Oral Tablet	PSN	5be7ee95-a27e-409d-881f-927f42074033	1
966224	levothyroxine sodium 125 MCG Oral Tablet	PSN	5be7ee95-a27e-409d-881f-927f42074033	1
966225	levothyroxine sodium 150 MCG Oral Tablet	PSN	5be7ee95-a27e-409d-881f-927f42074033	1
966249	levothyroxine sodium 175 MCG Oral Tablet	PSN	5be7ee95-a27e-409d-881f-927f42074033	1
892251	levothyroxine sodium 200 MCG Oral Tablet	PSN	5be7ee95-a27e-409d-881f-927f42074033	1
966220	levothyroxine sodium 25 MCG Oral Tablet	PSN	5be7ee95-a27e-409d-881f-927f42074033	1
966221	levothyroxine sodium 50 MCG Oral Tablet	PSN	5be7ee95-a27e-409d-881f-927f42074033	1
966222	levothyroxine sodium 75 MCG Oral Tablet	PSN	5be7ee95-a27e-409d-881f-927f42074033	1
966253	levothyroxine sodium 88 MCG Oral Tablet	PSN	5be7ee95-a27e-409d-881f-927f42074033	1
966250	SYNTHROID 100 MCG Oral Tablet	PSN	5be7ee95-a27e-409d-881f-927f42074033	1
966185	SYNTHROID 112 MCG Oral Tablet	PSN	5be7ee95-a27e-409d-881f-927f42074033	1
966191	SYNTHROID 125 MCG Oral Tablet	PSN	5be7ee95-a27e-409d-881f-927f42074033	1
966201	SYNTHROID 150 MCG Oral Tablet	PSN	5be7ee95-a27e-409d-881f-927f42074033	1
966205	SYNTHROID 175 MCG Oral Tablet	PSN	5be7ee95-a27e-409d-881f-927f42074033	1
966251	SYNTHROID 200 MCG Oral Tablet	PSN	5be7ee95-a27e-409d-881f-927f42074033	1
966158	SYNTHROID 25 MCG Oral Tablet	PSN	5be7ee95-a27e-409d-881f-927f42074033	1
966247	SYNTHROID 50 MCG Oral Tablet	PSN	5be7ee95-a27e-409d-881f-927f42074033	1
966171	SYNTHROID 75 MCG Oral Tablet	PSN	5be7ee95-a27e-409d-881f-927f42074033	1
966282	SYNTHROID 88 MCG Oral Tablet	PSN	5be7ee95-a27e-409d-881f-927f42074033	1
966158	levothyroxine sodium 0.025 MG Oral Tablet [Synthroid]	SBD	5be7ee95-a27e-409d-881f-927f42074033	1
966247	levothyroxine sodium 0.05 MG Oral Tablet [Synthroid]	SBD	5be7ee95-a27e-409d-881f-927f42074033	1
966171	levothyroxine sodium 0.075 MG Oral Tablet [Synthroid]	SBD	5be7ee95-a27e-409d-881f-927f42074033	1
966282	levothyroxine sodium 0.088 MG Oral Tablet [Synthroid]	SBD	5be7ee95-a27e-409d-881f-927f42074033	1
966250	levothyroxine sodium 0.1 MG Oral Tablet [Synthroid]	SBD	5be7ee95-a27e-409d-881f-927f42074033	1
966185	levothyroxine sodium 0.112 MG Oral Tablet [Synthroid]	SBD	5be7ee95-a27e-409d-881f-927f42074033	1
966191	levothyroxine sodium 0.125 MG Oral Tablet [Synthroid]	SBD	5be7ee95-a27e-409d-881f-927f42074033	1
966201	levothyroxine sodium 0.15 MG Oral Tablet [Synthroid]	SBD	5be7ee95-a27e-409d-881f-927f42074033	1
966205	levothyroxine sodium 0.175 MG Oral Tablet [Synthroid]	SBD	5be7ee95-a27e-409d-881f-927f42074033	1
966251	levothyroxine sodium 0.2 MG Oral Tablet [Synthroid]	SBD	5be7ee95-a27e-409d-881f-927f42074033	1
966220	levothyroxine sodium 0.025 MG Oral Tablet	SCD	5be7ee95-a27e-409d-881f-927f42074033	1
966221	levothyroxine sodium 0.05 MG Oral Tablet	SCD	5be7ee95-a27e-409d-881f-927f42074033	1
966222	levothyroxine sodium 0.075 MG Oral Tablet	SCD	5be7ee95-a27e-409d-881f-927f42074033	1
966253	levothyroxine sodium 0.088 MG Oral Tablet	SCD	5be7ee95-a27e-409d-881f-927f42074033	1
892246	levothyroxine sodium 0.1 MG Oral Tablet	SCD	5be7ee95-a27e-409d-881f-927f42074033	1
966248	levothyroxine sodium 0.112 MG Oral Tablet	SCD	5be7ee95-a27e-409d-881f-927f42074033	1
966224	levothyroxine sodium 0.125 MG Oral Tablet	SCD	5be7ee95-a27e-409d-881f-927f42074033	1
966225	levothyroxine sodium 0.15 MG Oral Tablet	SCD	5be7ee95-a27e-409d-881f-927f42074033	1
966249	levothyroxine sodium 0.175 MG Oral Tablet	SCD	5be7ee95-a27e-409d-881f-927f42074033	1
892251	levothyroxine sodium 0.2 MG Oral Tablet	SCD	5be7ee95-a27e-409d-881f-927f42074033	1
892246	levothyroxine sodium 100 MCG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966248	levothyroxine sodium 112 MCG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966224	levothyroxine sodium 125 MCG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966225	levothyroxine sodium 150 MCG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966249	levothyroxine sodium 175 MCG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
892251	levothyroxine sodium 200 MCG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966220	levothyroxine sodium 25 MCG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966221	levothyroxine sodium 50 MCG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966222	levothyroxine sodium 75 MCG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966253	levothyroxine sodium 88 MCG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966158	Synthroid 0.025 MG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966247	Synthroid 0.05 MG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966171	Synthroid 0.075 MG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966282	Synthroid 0.088 MG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966250	Synthroid 0.1 MG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966185	Synthroid 0.112 MG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966191	Synthroid 0.125 MG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966201	Synthroid 0.15 MG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966205	Synthroid 0.175 MG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966251	Synthroid 0.2 MG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966250	Synthroid 100 MCG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966185	Synthroid 112 MCG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966191	Synthroid 125 MCG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966201	Synthroid 150 MCG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966205	Synthroid 175 MCG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966251	Synthroid 200 MCG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966158	Synthroid 25 MCG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966247	Synthroid 50 MCG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966171	Synthroid 75 MCG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1
966282	Synthroid 88 MCG Oral Tablet	SY	5be7ee95-a27e-409d-881f-927f42074033	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
67544-887-30	67544088730	30 in 1 BOTTLE, PLASTIC	Historical
67544-887-60	67544088760	90 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SYNTHROID® (levothyroxine sodium tablets, USP)	Aphena Pharma Solutions - Tennessee, Inc.	2012-03-21	HUMAN PRESCRIPTION DRUG LABEL	1