Levothyroxine Sodium

Product NDC: 53002-1099
Requested package NDC: 53002-1099-0
11-digit product format: 530021099
Labeler code: 53002
Product ID: 53002-1099_3195c269-3116-4759-aea9-b8f272f53caa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levothyroxine Sodium
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: NDA021210
Marketing category: NDA
Marketing start: 2003-12-01
Marketing end: 0000-00-00
Substance: LEVOTHYROXINE SODIUM
Active strength: 0 mg/1
Pharmacologic classes: l-Thyroxine [EPC],Thyroxine [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53002-1099	53002-1099-0	D	Discontinued by firm		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 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	E	Excluded after deficient or non-compliant submission was not corrected	`9bebd1f3094a…`	`5416666fcb17…`

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
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 · 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	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 39 · 1,548 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	N021210-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-001	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-001	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-002	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-002	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-003	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-003	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-004	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-004	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-004	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-005	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-005	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-005	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-006	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-006	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-006	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-007	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-007	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-007	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-008	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-008	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-008	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-009	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-009	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-009	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-010	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-010	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-010	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-011	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-011	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-011	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-012	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-012	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-012	AB3	3	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021210-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-001	AB2	2	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-001	AB3	3	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-002	AB1	1	`caaa826d4ba7…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53002-1099-0	2023-06-08	Levothyroxine Sodium Tablets, USP
53002-1099-3	2023-06-08	Levothyroxine Sodium Tablets, USP
53002-1099-0	2023-01-30	Levothyroxine Sodium Tablets, USP
53002-1099-3	2023-01-30	Levothyroxine Sodium Tablets, USP

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-1099-0	53002109900	100 TABLET in 1 BOTTLE (53002-1099-0)	100 tablet	2018-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levothyroxine Sodium Tablets, USP	RPK Pharmaceuticals, Inc.	2020-12-15	HUMAN PRESCRIPTION DRUG LABEL	13