Levothyroxine sodium

Product NDC: 16729-453
11-digit product format: 167290453
Labeler code: 16729
Product ID: 16729-453_415fc774-31a5-124f-e063-6294a90a0e46
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levothyroxine Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Accord Healthcare Inc.
Application: ANDA212399
Marketing category: ANDA
Marketing start: 2020-12-03
Substance: LEVOTHYROXINE SODIUM
Active strength: 125 ug/1
Pharmacologic classes: Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	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 11 · 432 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
2026-02-19 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…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	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	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	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	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	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	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	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	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 34 · 1,344 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	A212399-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-001	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-001	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-001	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-002	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-002	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-002	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-003	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-003	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-003	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-004	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-004	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-004	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-004	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-005	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-005	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-005	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-005	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-006	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-006	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-006	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-006	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-007	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-007	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-007	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-007	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-008	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-008	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-008	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-008	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-009	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-009	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-009	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-009	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-010	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-010	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-010	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212399-010	AB4	4	`011fe1cb6892…`

Additional Listing Data#

Finished product: Yes
Brand name base: Levothyroxine sodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVOTHYROXINE SODIUM	125 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 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
892246	Internal RxNorm lookup
892251	Internal RxNorm lookup
892255	Internal RxNorm lookup
966220	Internal RxNorm lookup
966221	Internal RxNorm lookup
966222	Internal RxNorm lookup
966224	Internal RxNorm lookup
966225	Internal RxNorm lookup
966248	Internal RxNorm lookup
966249	Internal RxNorm lookup
966253	Internal RxNorm lookup
966270	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
a6233381-3043-4e9a-aaa6-a6b105e5142b	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16729-453-15	Levothyroxine sodium	90 in 1 BOTTLE	TABLET	90		11
16729-453-17	Levothyroxine sodium	1000 in 1 BOTTLE	TABLET	1000		11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-453	LEVOTHYROXINE SODIUM TABLET [ACCORD HEALTHCARE INC.]	10	Current NDC, Legacy NDC, 2 package rows	20241108_a6233381-3043-4e9a-aaa6-a6b105e5142b.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	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
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	a0fa8fa5-d3bd-4e52-9ec5-5fb84702826d	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	70853a82-ba3b-4663-9f78-6791ca72ba9f	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	7c8a6441-3c12-46ae-bb3b-a320d80045b6	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	008de8fd-150f-4022-8ccb-c8bfa94875c7	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212399 application number: ANDA212399
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	67f46137-afc4-471b-a6c7-9c2aef92da5d	2026-03-03	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
966224	levothyroxine sodium 125 MCG Oral Tablet	PSN	893f9d10-7ce5-4ae6-8f03-dfde35ca6c30	104
966224	levothyroxine sodium 0.125 MG Oral Tablet	SCD	893f9d10-7ce5-4ae6-8f03-dfde35ca6c30	104
966224	levothyroxine sodium 125 MCG Oral Tablet	SY	893f9d10-7ce5-4ae6-8f03-dfde35ca6c30	104
892246	levothyroxine sodium 100 MCG Oral Tablet	PSN	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966248	levothyroxine sodium 112 MCG Oral Tablet	PSN	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966224	levothyroxine sodium 125 MCG Oral Tablet	PSN	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966270	levothyroxine sodium 137 MCG Oral Tablet	PSN	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966225	levothyroxine sodium 150 MCG Oral Tablet	PSN	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966249	levothyroxine sodium 175 MCG Oral Tablet	PSN	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
892251	levothyroxine sodium 200 MCG Oral Tablet	PSN	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966220	levothyroxine sodium 25 MCG Oral Tablet	PSN	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
892255	levothyroxine sodium 300 MCG Oral Tablet	PSN	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966221	levothyroxine sodium 50 MCG Oral Tablet	PSN	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966222	levothyroxine sodium 75 MCG Oral Tablet	PSN	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966253	levothyroxine sodium 88 MCG Oral Tablet	PSN	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966220	levothyroxine sodium 0.025 MG Oral Tablet	SCD	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966221	levothyroxine sodium 0.05 MG Oral Tablet	SCD	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966222	levothyroxine sodium 0.075 MG Oral Tablet	SCD	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966253	levothyroxine sodium 0.088 MG Oral Tablet	SCD	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
892246	levothyroxine sodium 0.1 MG Oral Tablet	SCD	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966248	levothyroxine sodium 0.112 MG Oral Tablet	SCD	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966224	levothyroxine sodium 0.125 MG Oral Tablet	SCD	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966270	levothyroxine sodium 0.137 MG Oral Tablet	SCD	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966225	levothyroxine sodium 0.15 MG Oral Tablet	SCD	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966249	levothyroxine sodium 0.175 MG Oral Tablet	SCD	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
892251	levothyroxine sodium 0.2 MG Oral Tablet	SCD	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
892255	levothyroxine sodium 0.3 MG Oral Tablet	SCD	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
892246	levothyroxine sodium 100 MCG Oral Tablet	SY	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966248	levothyroxine sodium 112 MCG Oral Tablet	SY	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966224	levothyroxine sodium 125 MCG Oral Tablet	SY	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966270	levothyroxine sodium 137 MCG Oral Tablet	SY	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966225	levothyroxine sodium 150 MCG Oral Tablet	SY	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966249	levothyroxine sodium 175 MCG Oral Tablet	SY	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
892251	levothyroxine sodium 200 MCG Oral Tablet	SY	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966220	levothyroxine sodium 25 MCG Oral Tablet	SY	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
892255	levothyroxine sodium 300 MCG Oral Tablet	SY	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966221	levothyroxine sodium 50 MCG Oral Tablet	SY	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966222	levothyroxine sodium 75 MCG Oral Tablet	SY	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966253	levothyroxine sodium 88 MCG Oral Tablet	SY	a6233381-3043-4e9a-aaa6-a6b105e5142b	11
966224	levothyroxine sodium 125 MCG Oral Tablet	PSN	70853a82-ba3b-4663-9f78-6791ca72ba9f	9
966224	levothyroxine sodium 0.125 MG Oral Tablet	SCD	70853a82-ba3b-4663-9f78-6791ca72ba9f	9
966224	levothyroxine sodium 125 MCG Oral Tablet	SY	70853a82-ba3b-4663-9f78-6791ca72ba9f	9
966248	levothyroxine sodium 112 MCG Oral Tablet	PSN	83854522-f22e-491f-8392-c8b1f9441760	7
966224	levothyroxine sodium 125 MCG Oral Tablet	PSN	a0fa8fa5-d3bd-4e52-9ec5-5fb84702826d	7
966224	levothyroxine sodium 125 MCG Oral Tablet	PSN	83854522-f22e-491f-8392-c8b1f9441760	7
966253	levothyroxine sodium 88 MCG Oral Tablet	PSN	83854522-f22e-491f-8392-c8b1f9441760	7
966253	levothyroxine sodium 0.088 MG Oral Tablet	SCD	83854522-f22e-491f-8392-c8b1f9441760	7
966248	levothyroxine sodium 0.112 MG Oral Tablet	SCD	83854522-f22e-491f-8392-c8b1f9441760	7
966224	levothyroxine sodium 0.125 MG Oral Tablet	SCD	a0fa8fa5-d3bd-4e52-9ec5-5fb84702826d	7
966224	levothyroxine sodium 0.125 MG Oral Tablet	SCD	83854522-f22e-491f-8392-c8b1f9441760	7
966248	levothyroxine sodium 112 MCG Oral Tablet	SY	83854522-f22e-491f-8392-c8b1f9441760	7
966224	levothyroxine sodium 125 MCG Oral Tablet	SY	83854522-f22e-491f-8392-c8b1f9441760	7
966224	levothyroxine sodium 125 MCG Oral Tablet	SY	a0fa8fa5-d3bd-4e52-9ec5-5fb84702826d	7
966253	levothyroxine sodium 88 MCG Oral Tablet	SY	83854522-f22e-491f-8392-c8b1f9441760	7
966224	levothyroxine sodium 125 MCG Oral Tablet	PSN	cba6bb77-2140-6cba-e053-2995a90aa1b6	3
966224	levothyroxine sodium 0.125 MG Oral Tablet	SCD	cba6bb77-2140-6cba-e053-2995a90aa1b6	3
966224	levothyroxine sodium 125 MCG Oral Tablet	SY	cba6bb77-2140-6cba-e053-2995a90aa1b6	3
892246	levothyroxine sodium 100 MCG Oral Tablet	PSN	42a26f8a-dc67-42e4-abb0-d2602afb1b7d	1
966248	levothyroxine sodium 112 MCG Oral Tablet	PSN	42a26f8a-dc67-42e4-abb0-d2602afb1b7d	1
966224	levothyroxine sodium 125 MCG Oral Tablet	PSN	7fd988be-ab3d-406d-a55d-1e5a8a2101cc	1
966224	levothyroxine sodium 125 MCG Oral Tablet	PSN	42a26f8a-dc67-42e4-abb0-d2602afb1b7d	1
966224	levothyroxine sodium 125 MCG Oral Tablet	PSN	2f129a3d-f3e6-45b2-9704-3ad171cbd8a5	1
966270	levothyroxine sodium 137 MCG Oral Tablet	PSN	42a26f8a-dc67-42e4-abb0-d2602afb1b7d	1
966225	levothyroxine sodium 150 MCG Oral Tablet	PSN	42a26f8a-dc67-42e4-abb0-d2602afb1b7d	1
966249	levothyroxine sodium 175 MCG Oral Tablet	PSN	42a26f8a-dc67-42e4-abb0-d2602afb1b7d	1
892251	levothyroxine sodium 200 MCG Oral Tablet	PSN	42a26f8a-dc67-42e4-abb0-d2602afb1b7d	1
966220	levothyroxine sodium 25 MCG Oral Tablet	PSN	42a26f8a-dc67-42e4-abb0-d2602afb1b7d	1
892255	levothyroxine sodium 300 MCG Oral Tablet	PSN	42a26f8a-dc67-42e4-abb0-d2602afb1b7d	1
966221	levothyroxine sodium 50 MCG Oral Tablet	PSN	42a26f8a-dc67-42e4-abb0-d2602afb1b7d	1
966222	levothyroxine sodium 75 MCG Oral Tablet	PSN	42a26f8a-dc67-42e4-abb0-d2602afb1b7d	1
966253	levothyroxine sodium 88 MCG Oral Tablet	PSN	42a26f8a-dc67-42e4-abb0-d2602afb1b7d	1
966220	levothyroxine sodium 0.025 MG Oral Tablet	SCD	42a26f8a-dc67-42e4-abb0-d2602afb1b7d	1
966221	levothyroxine sodium 0.05 MG Oral Tablet	SCD	42a26f8a-dc67-42e4-abb0-d2602afb1b7d	1
966222	levothyroxine sodium 0.075 MG Oral Tablet	SCD	42a26f8a-dc67-42e4-abb0-d2602afb1b7d	1
966253	levothyroxine sodium 0.088 MG Oral Tablet	SCD	42a26f8a-dc67-42e4-abb0-d2602afb1b7d	1
892246	levothyroxine sodium 0.1 MG Oral Tablet	SCD	42a26f8a-dc67-42e4-abb0-d2602afb1b7d	1
966248	levothyroxine sodium 0.112 MG Oral Tablet	SCD	42a26f8a-dc67-42e4-abb0-d2602afb1b7d	1
966224	levothyroxine sodium 0.125 MG Oral Tablet	SCD	42a26f8a-dc67-42e4-abb0-d2602afb1b7d	1
966224	levothyroxine sodium 0.125 MG Oral Tablet	SCD	7fd988be-ab3d-406d-a55d-1e5a8a2101cc	1
966224	levothyroxine sodium 0.125 MG Oral Tablet	SCD	2f129a3d-f3e6-45b2-9704-3ad171cbd8a5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-453-15	16729045315	90 TABLET in 1 BOTTLE (16729-453-15)	90 tablet	2020-12-03	0000-00-00	No	No	Current
16729-453-17	16729045317	1000 TABLET in 1 BOTTLE (16729-453-17)	1000 tablet	2020-12-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levothyroxine sodium	Preferred Pharmaceuticals Inc.	2026-05-20	HUMAN PRESCRIPTION DRUG LABEL	7
Levothyroxine sodium	A-S Medication Solutions	2026-03-27	HUMAN PRESCRIPTION DRUG LABEL	9
Levothyroxine sodium	A-S Medication Solutions	2026-03-27	HUMAN PRESCRIPTION DRUG LABEL	7
Levothyroxine sodium	ASCLEMED USA INC. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-02-06	HUMAN PRESCRIPTION DRUG LABEL	1
Levothyroxine sodium	Accord Healthcare Inc. \| Excella GmbH & Co. KG \| Intas Pharmaceuticals Limited	2025-10-17	HUMAN PRESCRIPTION DRUG LABEL	11
Levothyroxine sodium	REMEDYREPACK INC.	2025-07-24	HUMAN PRESCRIPTION DRUG LABEL	1
Levothyroxine sodium	Bryant Ranch Prepack	2024-12-11	HUMAN PRESCRIPTION DRUG LABEL	104
Levothyroxine sodium	NuCare Pharmaceuticals,Inc.	2024-07-14	HUMAN PRESCRIPTION DRUG LABEL	3
Levothyroxine sodium	Proficient Rx LP	2022-08-01	HUMAN PRESCRIPTION DRUG LABEL	1
Levothyroxine sodium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2022-01-04	HUMAN PRESCRIPTION DRUG LABEL	1