Levothyroxine sodium

Product NDC: 68071-2532
Requested package NDC: 68071-2532-9
11-digit product format: 680712532
Labeler code: 68071
Product ID: 68071-2532_cba64782-bfa3-9dba-e053-2995a90a413d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levothyroxine Sodium
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA212399
Marketing category: ANDA
Marketing start: 2020-11-25
Marketing end: 0000-00-00
Substance: LEVOTHYROXINE SODIUM
Active strength: 150 ug/1
Pharmacologic classes: l-Thyroxine [EPC],Thyroxine [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	68071-2532	68071-2532-9	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 · 9 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	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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	Approval date
A212399-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19
A212399-002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19
A212399-003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19
A212399-004	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19
A212399-005	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19
A212399-006	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19
A212399-007	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19
A212399-008	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19
A212399-009	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19
A212399-010	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19
A212399-011	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19
A212399-012	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212399-001	AB1
A212399-001	AB2
A212399-001	AB3
A212399-001	AB4
A212399-002	AB1
A212399-002	AB2
A212399-002	AB3
A212399-002	AB4
A212399-003	AB1
A212399-003	AB2
A212399-003	AB3
A212399-003	AB4
A212399-004	AB1
A212399-004	AB2
A212399-004	AB3
A212399-004	AB4
A212399-005	AB1
A212399-005	AB2
A212399-005	AB3
A212399-005	AB4
A212399-006	AB1
A212399-006	AB2
A212399-006	AB3
A212399-006	AB4
A212399-007	AB1
A212399-007	AB2
A212399-007	AB3
A212399-007	AB4
A212399-008	AB1
A212399-008	AB2
A212399-008	AB3
A212399-008	AB4
A212399-009	AB1
A212399-009	AB2
A212399-009	AB3
A212399-009	AB4
A212399-010	AB1
A212399-010	AB2
A212399-010	AB3
A212399-010	AB4
A212399-011	AB1
A212399-011	AB2
A212399-011	AB3
A212399-011	AB4
A212399-012	AB1
A212399-012	AB2
A212399-012	AB3
A212399-012	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 12 · 456 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A212399-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212399-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212399-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212399-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212399-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212399-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212399-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212399-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212399-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212399-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212399-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212399-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212399-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212399-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212399-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212399-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212399-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212399-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2020-10-19	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 36 · 1,440 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	A212399-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-001	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-001	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-001	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-002	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-002	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-002	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-003	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-003	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-003	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-004	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-004	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-004	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-004	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-005	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-005	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-005	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-005	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-006	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-006	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-006	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-006	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-007	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-007	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-007	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-007	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-008	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-008	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-008	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-008	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-009	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-009	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-009	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-009	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-010	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-010	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-010	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212399-010	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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
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
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-2532-3	2025-01-30	These highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002
68071-2532-9	2025-01-30	These highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002
68071-2532-3	2023-07-14	These highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002
68071-2532-9	2023-07-14	These highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002
68071-2532-3	2023-01-30	These highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002
68071-2532-9	2023-01-30	These highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2532-3	Levothyroxine sodium	30 in 1 BOTTLE	TABLET	30		2
68071-2532-9	Levothyroxine sodium	90 in 1 BOTTLE	TABLET	90		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2532	LEVOTHYROXINE SODIUM TABLET [NUCARE PHARMACEUTICALS,INC.]	2	Legacy NDC, 2 package rows	20230715_cba64919-3b74-a03a-e053-2995a90a3d89.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 4 · 69 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	bc9385d0-5c67-4bde-94da-e621347e2cba	2026-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	4c903249-69e9-4168-a9d1-22e6c2c1eb22	2026-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	6f25cbb3-0358-4778-b8f0-f76479a2dcc5	2026-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	7fd988be-ab3d-406d-a55d-1e5a8a2101cc	2026-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	6108759a-783e-42ca-b078-6a3cd84ce901	2026-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	4f40db1e-3dd9-4c7b-93e6-64f0fd10d551	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	6d65b528-f52b-4b5d-8b76-46fbd4576f99	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	c38c3c31-6834-4590-ace0-f525e5599f66	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	83854522-f22e-491f-8392-c8b1f9441760	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	633b3f9c-9578-4e07-a515-aec1a8b65e92	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	0cffbc96-7a02-4538-9966-b69249be6eb2	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	775ef7ba-0b5b-40ba-ac7b-2aef121fe4f4	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	231fcdf8-c642-4074-8be8-53ee9c918f18	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	251e65e0-6925-4984-9df9-d6d7c6d0703c	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	741a8b30-86e1-4f37-917a-73265a82ee07	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	4a2c8e57-d52d-409f-83d8-731b721bf613	2026-04-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	f347d92a-7726-4165-bc3c-f5b37ec86f9f	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	f8c14539-8ed1-406a-9b58-8ba3a7ce7ee3	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	55cebc88-0514-4940-b974-ec7f0467d10e	2026-04-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	c7d5b71b-e983-4b1a-bfc2-d2343cf8668c	2026-04-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399

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
966225	levothyroxine sodium 150 MCG Oral Tablet	PSN	cba64919-3b74-a03a-e053-2995a90a3d89	2
966225	levothyroxine sodium 0.15 MG Oral Tablet	SCD	cba64919-3b74-a03a-e053-2995a90a3d89	2
966225	levothyroxine sodium 150 MCG Oral Tablet	SY	cba64919-3b74-a03a-e053-2995a90a3d89	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2532-9	68071253209	90 TABLET in 1 BOTTLE (68071-2532-9)	90 tablet	2021-09-10	0000-00-00	No	No	Current