LEVOTHYROXINE SODIUM

Product NDC: 67046-1679
Requested package NDC: 67046-1679-3
11-digit product format: 670461679
Labeler code: 67046
Product ID: 67046-1679_5383aefc-8f33-44de-e063-6394a90ad4d8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LEVOTHYROXINE SODIUM
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA211417
Marketing category: ANDA
Marketing start: 2026-06-05
Substance: LEVOTHYROXINE SODIUM
Active strength: 100 ug/1
Pharmacologic classes: Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A211417-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-004	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-005	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-006	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-007	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-008	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-009	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-010	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-011	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-012	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211417-001	AB1
A211417-001	AB2
A211417-001	AB3
A211417-001	AB4
A211417-002	AB1
A211417-002	AB2
A211417-002	AB3
A211417-002	AB4
A211417-003	AB1
A211417-003	AB2
A211417-003	AB3
A211417-003	AB4
A211417-004	AB1
A211417-004	AB2
A211417-004	AB3
A211417-004	AB4
A211417-005	AB1
A211417-005	AB2
A211417-005	AB3
A211417-005	AB4
A211417-006	AB1
A211417-006	AB2
A211417-006	AB3
A211417-006	AB4
A211417-007	AB1
A211417-007	AB2
A211417-007	AB3
A211417-007	AB4
A211417-008	AB1
A211417-008	AB2
A211417-008	AB3
A211417-008	AB4
A211417-009	AB1
A211417-009	AB2
A211417-009	AB3
A211417-009	AB4
A211417-010	AB1
A211417-010	AB2
A211417-010	AB3
A211417-010	AB4
A211417-011	AB1
A211417-011	AB2
A211417-011	AB3
A211417-011	AB4
A211417-012	AB1
A211417-012	AB2
A211417-012	AB3
A211417-012	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 8 · 312 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	A211417-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211417-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211417-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211417-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211417-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211417-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211417-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211417-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211417-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211417-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211417-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211417-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211417-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211417-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211417-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211417-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211417-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211417-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 16 · 636 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	A211417-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-001	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-001	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-001	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-002	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-002	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-002	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-003	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-003	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-003	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-004	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-004	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-004	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-004	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-005	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-005	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-005	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-005	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-006	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-006	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-006	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-006	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-007	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-007	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-007	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-007	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-008	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-008	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-008	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-008	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-009	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-009	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-009	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-009	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-010	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-010	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-010	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-010	AB4	4	`84e616aacf4f…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: LEVOTHYROXINE SODIUM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVOTHYROXINE SODIUM	100 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9J765S329G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
892246	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5383a4d8-319a-5bf6-e063-6294a90a5497	Available on FDA.report

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	NorthStar RxLLC	58f4dc90-3648-49dc-a7e1-baf918a773b5	2026-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Coupler LLC	5383a4d8-319a-5bf6-e063-6294a90a5497	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417 ndc (package): 67046-1679-3 ndc (product): 67046-1679 ndc11 (package): 67046167903
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals,Inc.	510349d0-6397-7e2b-e063-6394a90a8a68	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	853d9e86-2b5b-4967-8c22-70ad34f03418	2026-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	b42fe9dd-8383-4839-9eab-393de388da71	2026-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	394b1006-c160-4668-8684-82d1c4481202	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	8e11401b-f5c2-42ac-ba63-2e71b5626b7e	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	2b737395-0238-400b-95ff-890b95c98425	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	1ac29774-2b53-4a3f-97fa-16c2880a0868	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals, Inc.	3d737f79-7fc9-4221-e063-6394a90ac9aa	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	2adb05ef-b3fa-4ac2-b219-99442746392b	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	d5b005e8-a88d-450b-bbc3-393d885260f5	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	2aab0208-81ad-4607-8196-b4dc5ad5fdaa	2025-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	194bc35b-ac82-4a40-bbd4-68eaff50b380	2025-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	37a55040-a9a2-4ff4-8463-9e1c7823d6ff	2025-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	2e242b93-bc4f-405a-a194-1981c721ad94	2025-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	609352a9-740f-4874-997b-60b58d0c2b8a	2025-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	cfab474d-3272-41fd-a8ec-762dd1a84fa6	2025-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	b9a50170-ac0b-483e-9e85-1d03b12e4f7d	2025-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	247f4d1d-6e65-4f81-a377-4dd88ae16dbb	2025-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417

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	Sample	Exclude flag	Status
67046-1679-3	67046167903	30 TABLET in 1 BLISTER PACK (67046-1679-3)	30 tablet	2026-06-05	No	No	Current