Levothyroxine Sodium

Product NDC: 10544-266
11-digit product format: 105440266
Labeler code: 10544
Product ID: 10544-266_1221a437-07b0-291f-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levothyroxine Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: NDA021210
Marketing category: NDA
Marketing start: 2013-11-18
Marketing end: 0000-00-00
Substance: LEVOTHYROXINE SODIUM
Active strength: 0 mg/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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	10544-266		I	Inactivated by FDA		2026-08-03
excluded package	package	10544-266	10544-266-30	I	Inactivated by FDA		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 · 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	10544-266-30	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	10544-266-30	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	10544-266-30	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	10544-266-30	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	10544-266-30	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	10544-266-30	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	10544-266-30	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	10544-266-30	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	10544-266-30	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	10544-266-30	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	10544-266-30	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	10544-266-30	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	10544-266-30	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	10544-266-30	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	10544-266-30	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	10544-266-30	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	10544-266-30	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	10544-266-30	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	10544-266-30	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10544-266-30	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	10544-266-30	I	Inactivated by FDA	`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	10544-266-30	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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	RLD / RS	Approval date
N021210-001	UNITHROID	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-002	UNITHROID	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-003	UNITHROID	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-004	UNITHROID	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-005	UNITHROID	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-006	UNITHROID	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-007	UNITHROID	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-008	UNITHROID	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-009	UNITHROID	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-010	UNITHROID	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-011	UNITHROID	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD, RS	2000-08-21
N021210-012	UNITHROID	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2008-02-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021210-001	AB1
N021210-001	AB2
N021210-001	AB3
N021210-002	AB1
N021210-002	AB2
N021210-002	AB3
N021210-003	AB1
N021210-003	AB2
N021210-003	AB3
N021210-004	AB1
N021210-004	AB2
N021210-004	AB3
N021210-005	AB1
N021210-005	AB2
N021210-005	AB3
N021210-006	AB1
N021210-006	AB2
N021210-006	AB3
N021210-007	AB1
N021210-007	AB2
N021210-007	AB3
N021210-008	AB1
N021210-008	AB2
N021210-008	AB3
N021210-009	AB1
N021210-009	AB2
N021210-009	AB3
N021210-010	AB1
N021210-010	AB2
N021210-010	AB3
N021210-011	AB1
N021210-011	AB2
N021210-011	AB3
N021210-012	AB1
N021210-012	AB2
N021210-012	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021210-001	UNITHROID	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-002	UNITHROID	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-003	UNITHROID	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-004	UNITHROID	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-005	UNITHROID	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-006	UNITHROID	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-007	UNITHROID	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-008	UNITHROID	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-009	UNITHROID	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-010	UNITHROID	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-011	UNITHROID	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD, RS	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-012	UNITHROID	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2008-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021210-001	UNITHROID	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021210-002	UNITHROID	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021210-003	UNITHROID	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021210-004	UNITHROID	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021210-005	UNITHROID	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021210-006	UNITHROID	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021210-007	UNITHROID	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021210-008	UNITHROID	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021210-009	UNITHROID	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021210-010	UNITHROID	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021210-011	UNITHROID	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD, RS	2000-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021210-012	UNITHROID	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2008-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021210-001	UNITHROID	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021210-002	UNITHROID	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021210-003	UNITHROID	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021210-004	UNITHROID	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021210-005	UNITHROID	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021210-006	UNITHROID	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021210-007	UNITHROID	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021210-008	UNITHROID	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021210-009	UNITHROID	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021210-010	UNITHROID	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021210-011	UNITHROID	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD, RS	2000-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021210-012	UNITHROID	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2008-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021210-001	UNITHROID	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021210-002	UNITHROID	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021210-003	UNITHROID	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021210-004	UNITHROID	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`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	N021210-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-001	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-001	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-002	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-002	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-003	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-003	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-004	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-004	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-004	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-005	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-005	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-005	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-006	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-006	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-006	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-007	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-007	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-007	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-008	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-008	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-008	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-009	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-009	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-009	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-010	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-010	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-010	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-011	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-011	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-011	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-012	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-012	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-012	AB3	3	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021210-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021210-001	AB2	2	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021210-001	AB3	3	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021210-002	AB1	1	`31067a03dcf5…`

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
10544-266-30	2020-01-31	C162847	48780-1	9d75b9d0-8704-f424-e053-dadaa90a57ce	Levothyroxine Sodium Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-266-30	Levothyroxine Sodium	30 in 1 BOTTLE, PLASTIC	TABLET	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-266-30	EA - Each	10544-266	c93fc4f8-6102-4ef4-b48f-1b32a82e46ac	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOTHYROXINE SODIUM	ACTIVE INGREDIENT	9J765S329G	LEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	4
LEVOTHYROXINE	ACTIVE MOIETY	Q51BO43MG4	LEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	4
ACACIA	INACTIVE INGREDIENT	5C5403N26O	LEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	4
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	LEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	4
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-266	LEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	4	Legacy NDC, 1 package rows	20150326_0f547137-d471-15f6-e054-00144ff8d46c.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	abe173cc-1579-43a5-b12d-a31958d0a539	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	c968836a-f94c-4d13-e053-2995a90a8df5	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Amneal Pharmaceuticals NY LLC	fca88c97-5cd4-4834-ba87-deb5bd637788	2024-12-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	2f0657d5-3e5c-4249-bfaa-7f5ef1528672	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	97e28b00-9913-463f-9de2-08c828edbe67	2020-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	05ab038e-45fa-488e-a05e-12a2dd3564c1	2020-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	b81720f9-2836-4c1d-8691-0f6acef13316	2020-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	434075d5-a82b-4f17-85e6-4c1922663dbc	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	18c7c63a-642e-47fe-a8ee-12aaf652b2aa	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Unithroid	LEVOTHYROXINE SODIUM	Amneal Pharmaceuticals LLC	07562e72-7eaa-4ce6-94f0-e08814787e50	2019-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210

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	0f547137-d471-15f6-e054-00144ff8d46c	4
966248	levothyroxine sodium 112 MCG Oral Tablet	PSN	0f547137-d471-15f6-e054-00144ff8d46c	4
966224	levothyroxine sodium 125 MCG Oral Tablet	PSN	0f547137-d471-15f6-e054-00144ff8d46c	4
966270	levothyroxine sodium 137 MCG Oral Tablet	PSN	0f547137-d471-15f6-e054-00144ff8d46c	4
966225	levothyroxine sodium 150 MCG Oral Tablet	PSN	0f547137-d471-15f6-e054-00144ff8d46c	4
966220	levothyroxine sodium 25 MCG Oral Tablet	PSN	0f547137-d471-15f6-e054-00144ff8d46c	4
966221	levothyroxine sodium 50 MCG Oral Tablet	PSN	0f547137-d471-15f6-e054-00144ff8d46c	4
966222	levothyroxine sodium 75 MCG Oral Tablet	PSN	0f547137-d471-15f6-e054-00144ff8d46c	4
966253	levothyroxine sodium 88 MCG Oral Tablet	PSN	0f547137-d471-15f6-e054-00144ff8d46c	4
966220	levothyroxine sodium 0.025 MG Oral Tablet	SCD	0f547137-d471-15f6-e054-00144ff8d46c	4
966221	levothyroxine sodium 0.05 MG Oral Tablet	SCD	0f547137-d471-15f6-e054-00144ff8d46c	4
966222	levothyroxine sodium 0.075 MG Oral Tablet	SCD	0f547137-d471-15f6-e054-00144ff8d46c	4
966253	levothyroxine sodium 0.088 MG Oral Tablet	SCD	0f547137-d471-15f6-e054-00144ff8d46c	4
892246	levothyroxine sodium 0.1 MG Oral Tablet	SCD	0f547137-d471-15f6-e054-00144ff8d46c	4
966248	levothyroxine sodium 0.112 MG Oral Tablet	SCD	0f547137-d471-15f6-e054-00144ff8d46c	4
966224	levothyroxine sodium 0.125 MG Oral Tablet	SCD	0f547137-d471-15f6-e054-00144ff8d46c	4
966270	levothyroxine sodium 0.137 MG Oral Tablet	SCD	0f547137-d471-15f6-e054-00144ff8d46c	4
966225	levothyroxine sodium 0.15 MG Oral Tablet	SCD	0f547137-d471-15f6-e054-00144ff8d46c	4
892246	levothyroxine sodium 100 MCG Oral Tablet	SY	0f547137-d471-15f6-e054-00144ff8d46c	4
966248	levothyroxine sodium 112 MCG Oral Tablet	SY	0f547137-d471-15f6-e054-00144ff8d46c	4
966224	levothyroxine sodium 125 MCG Oral Tablet	SY	0f547137-d471-15f6-e054-00144ff8d46c	4
966270	levothyroxine sodium 137 MCG Oral Tablet	SY	0f547137-d471-15f6-e054-00144ff8d46c	4
966225	levothyroxine sodium 150 MCG Oral Tablet	SY	0f547137-d471-15f6-e054-00144ff8d46c	4
966220	levothyroxine sodium 25 MCG Oral Tablet	SY	0f547137-d471-15f6-e054-00144ff8d46c	4
966221	levothyroxine sodium 50 MCG Oral Tablet	SY	0f547137-d471-15f6-e054-00144ff8d46c	4
966222	levothyroxine sodium 75 MCG Oral Tablet	SY	0f547137-d471-15f6-e054-00144ff8d46c	4
966253	levothyroxine sodium 88 MCG Oral Tablet	SY	0f547137-d471-15f6-e054-00144ff8d46c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-266-30	10544026630	30 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levothyroxine Sodium Tablets, USP	Blenheim Pharmacal, Inc.	2015-03-25	HUMAN PRESCRIPTION DRUG LABEL	4