Levothyroxine Sodium

Product NDC: 0904-6954
11-digit product format: 009046954
Labeler code: 0904
Product ID: 0904-6954_942c00a3-b31c-48d5-a63d-6d394645ee1f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levothyroxine Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA209713
Marketing category: ANDA
Marketing start: 2019-03-20
Substance: LEVOTHYROXINE SODIUM
Active strength: .112 mg/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
A209713-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18
A209713-002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18
A209713-003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18
A209713-004	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18
A209713-005	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18
A209713-006	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18
A209713-007	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18
A209713-008	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18
A209713-009	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18
A209713-010	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18
A209713-011	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18
A209713-012	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209713-001	AB1
A209713-001	AB2
A209713-001	AB3
A209713-002	AB1
A209713-002	AB2
A209713-002	AB3
A209713-003	AB1
A209713-003	AB2
A209713-003	AB3
A209713-004	AB1
A209713-004	AB2
A209713-004	AB3
A209713-005	AB1
A209713-005	AB2
A209713-005	AB3
A209713-006	AB1
A209713-006	AB2
A209713-006	AB3
A209713-007	AB1
A209713-007	AB2
A209713-007	AB3
A209713-008	AB1
A209713-008	AB2
A209713-008	AB3
A209713-009	AB1
A209713-009	AB2
A209713-009	AB3
A209713-010	AB1
A209713-010	AB2
A209713-010	AB3
A209713-011	AB1
A209713-011	AB2
A209713-011	AB3
A209713-012	AB1
A209713-012	AB2
A209713-012	AB3

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 13 · 492 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209713-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209713-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209713-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209713-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209713-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209713-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209713-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209713-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209713-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209713-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209713-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209713-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209713-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209713-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209713-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209713-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209713-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209713-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209713-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209713-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209713-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209713-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209713-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209713-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209713-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209713-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209713-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209713-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209713-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 36 · 1,428 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	A209713-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-001	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-001	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-002	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-002	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-003	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-003	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-004	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-004	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-004	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-005	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-005	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-005	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-006	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-006	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-006	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-007	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-007	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-007	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-008	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-008	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-008	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-009	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-009	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-009	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-010	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-010	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-010	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-011	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-011	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-011	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-012	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-012	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-012	AB3	3	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209713-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209713-001	AB2	2	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209713-001	AB3	3	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209713-002	AB1	1	`31067a03dcf5…`

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	.112 mg/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 · 9 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
892246	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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
333642fd-93ae-4dc0-9c83-6d6b163c1c74	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
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
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
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
6a33ec05-2ae2-45e5-ab82-2d94b3303923	Product name	1	20190709
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
93355a10-1c44-4c92-a11d-7d995e0200d9	Product name	1	20190219
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-6954-61	Levothyroxine Sodium	100 in 1 CARTON	TABLET	100		8
0904-6954-61	Levothyroxine Sodium	1 in 1 BLISTER PACK	TABLET	1		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6954-61	EA - Each	0904-6954	93aeb1e9-8bf9-415d-a462-587ad6b48dfa	1	2020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6954	LEVOTHYROXINE SODIUM TABLET [MAJOR PHARMACEUTICALS]	7	Current NDC, Legacy NDC, 2 package rows	20241128_333642fd-93ae-4dc0-9c83-6d6b163c1c74.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 · 62 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	55f4c679-86cb-b97f-e063-6294a90ad5ef	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	55f67831-4680-edbf-e063-6294a90a1d36	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	544d67eb-8487-cb5d-e063-6394a90a3110	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	53e84179-fe2a-5696-e063-6394a90a8566	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	53316e75-9897-4935-e063-6294a90a94cf	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	c8ae9dc4-836f-4912-80d7-684fd374f40a	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	52cce695-4363-8a2c-e063-6294a90a1bbf	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	52cd19e4-a4b3-ecee-e063-6394a90ac33b	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	51b68266-95d2-c166-e063-6294a90a534f	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	50fe00b3-6610-1cac-e063-6294a90af8ac	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	5100c561-0028-a3c0-e063-6394a90addeb	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	f94a81e2-49cd-430a-acda-1a47d5c5b59b	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	0235176b-ec39-44c4-a9e1-e0729a7989fa	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	7d07e932-7372-4c17-aa53-55087107fa52	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	2ecaa38f-8a6f-4536-8033-251d2c52ae64	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	991399a4-ff94-44d0-b1ba-1f89e7759498	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	87333260-fe57-4d99-886c-7c66cb063898	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	99df68ea-4de7-4825-a6d7-894c70d01c28	2026-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	4f26f9dc-cf49-4b55-a6f7-f2f579893ee4	2026-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	ffc34bc6-5de5-addb-e053-6294a90a25be	2026-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9J765S329G	LEVOTHYROXINE SODIUM	6106-07-6	LEVOTHYROXINE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
892246	levothyroxine sodium 100 MCG Oral Tablet	PSN	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
966248	levothyroxine sodium 112 MCG Oral Tablet	PSN	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
966224	levothyroxine sodium 125 MCG Oral Tablet	PSN	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
966225	levothyroxine sodium 150 MCG Oral Tablet	PSN	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
966249	levothyroxine sodium 175 MCG Oral Tablet	PSN	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
966220	levothyroxine sodium 25 MCG Oral Tablet	PSN	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
966221	levothyroxine sodium 50 MCG Oral Tablet	PSN	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
966222	levothyroxine sodium 75 MCG Oral Tablet	PSN	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
966253	levothyroxine sodium 88 MCG Oral Tablet	PSN	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
966220	levothyroxine sodium 0.025 MG Oral Tablet	SCD	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
966221	levothyroxine sodium 0.05 MG Oral Tablet	SCD	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
966222	levothyroxine sodium 0.075 MG Oral Tablet	SCD	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
966253	levothyroxine sodium 0.088 MG Oral Tablet	SCD	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
892246	levothyroxine sodium 0.1 MG Oral Tablet	SCD	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
966248	levothyroxine sodium 0.112 MG Oral Tablet	SCD	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
966224	levothyroxine sodium 0.125 MG Oral Tablet	SCD	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
966225	levothyroxine sodium 0.15 MG Oral Tablet	SCD	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
966249	levothyroxine sodium 0.175 MG Oral Tablet	SCD	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
892246	levothyroxine sodium 100 MCG Oral Tablet	SY	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
966248	levothyroxine sodium 112 MCG Oral Tablet	SY	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
966224	levothyroxine sodium 125 MCG Oral Tablet	SY	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
966225	levothyroxine sodium 150 MCG Oral Tablet	SY	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
966249	levothyroxine sodium 175 MCG Oral Tablet	SY	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
966220	levothyroxine sodium 25 MCG Oral Tablet	SY	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
966221	levothyroxine sodium 50 MCG Oral Tablet	SY	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
966222	levothyroxine sodium 75 MCG Oral Tablet	SY	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8
966253	levothyroxine sodium 88 MCG Oral Tablet	SY	333642fd-93ae-4dc0-9c83-6d6b163c1c74	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6954-61	00904695461	100 BLISTER PACK in 1 CARTON (0904-6954-61) / 1 TABLET in 1 BLISTER PACK	100 blister pack	2019-03-20	0000-00-00	No	No	Current