Levothyroxine Sodium

Product NDC: 0378-1807
11-digit product format: 003781807
Labeler code: 0378
Product ID: 0378-1807_ca193039-55b1-4a7e-aa67-c4bff4f9f5b0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levothyroxine sodium
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA076187
Marketing category: ANDA
Marketing start: 2002-11-01
Substance: LEVOTHYROXINE SODIUM
Active strength: 88 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	RLD / RS	Approval date
A076187-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-004	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-005	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-006	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-007	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-008	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-009	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-010	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-011	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	RS	2002-06-05
A076187-012	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2006-12-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076187-001	AB1
A076187-001	AB2
A076187-001	AB3
A076187-001	AB4
A076187-002	AB1
A076187-002	AB2
A076187-002	AB3
A076187-002	AB4
A076187-003	AB1
A076187-003	AB2
A076187-003	AB3
A076187-003	AB4
A076187-004	AB1
A076187-004	AB2
A076187-004	AB3
A076187-004	AB4
A076187-005	AB1
A076187-005	AB2
A076187-005	AB3
A076187-005	AB4
A076187-006	AB1
A076187-006	AB2
A076187-006	AB3
A076187-006	AB4
A076187-007	AB1
A076187-007	AB2
A076187-007	AB3
A076187-007	AB4
A076187-008	AB1
A076187-008	AB2
A076187-008	AB3
A076187-008	AB4
A076187-009	AB1
A076187-009	AB2
A076187-009	AB3
A076187-009	AB4
A076187-010	AB1
A076187-010	AB2
A076187-010	AB3
A076187-010	AB4
A076187-011	AB1
A076187-011	AB2
A076187-011	AB3
A076187-011	AB4
A076187-012	AB1
A076187-012	AB2
A076187-012	AB3
A076187-012	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 13 · 492 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076187-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-008	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-009	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-010	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-011	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	RS	2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-012	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2006-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-008	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-009	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-010	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-011	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	RS	2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-012	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2006-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076187-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076187-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076187-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076187-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076187-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076187-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076187-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076187-008	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076187-009	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076187-010	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076187-011	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	RS	2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076187-012	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2006-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076187-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076187-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076187-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076187-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 50 · 1,968 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	A076187-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-001	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-001	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-001	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-002	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-002	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-002	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-003	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-003	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-003	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-004	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-004	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-004	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-004	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-005	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-005	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-005	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-005	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-006	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-006	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-006	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-006	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-007	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-007	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-007	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-007	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-008	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-008	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-008	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-008	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-009	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-009	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-009	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-009	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-010	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-010	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-010	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-010	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	88 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
e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	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
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
6a33ec05-2ae2-45e5-ab82-2d94b3303923	Product name	1	20190709
93355a10-1c44-4c92-a11d-7d995e0200d9	Product name	1	20190219
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
0378-1807-10	Levothyroxine Sodium	1000 in 1 BOTTLE, PLASTIC	TABLET	1000		31
0378-1807-77	Levothyroxine Sodium	90 in 1 BOTTLE, PLASTIC	TABLET	90		31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-1807-01	EA - Each	0378-1807	8c51130c-7b0a-40c9-bd80-d8b8a6fc9f09	1	2012-07-24
0378-1807-04	EA - Each	0378-1807	ed56adb8-67a7-492d-a463-5dd63be72324	1	2020-09-14
0378-1807-10	EA - Each	0378-1807	09d6916c-4da6-4807-99d4-6cfa7c41e051	1	2012-07-24
0378-1807-77	EA - Each	0378-1807	fd9ddea0-5ffd-4154-8ae7-f178279b6336	1	2016-07-19
0378-1807-95	EA - Each	0378-1807	2d1d14f5-e12f-4935-9f71-5cc438848871	1	2020-09-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOTHYROXINE SODIUM	ACTIVE INGREDIENT	9J765S329G	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
LEVOTHYROXINE	ACTIVE MOIETY	Q51BO43MG4	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
SUCROSE	INACTIVE INGREDIENT	C151H8M554	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	6
LEVOTHYROXINE SODIUM	ACTIVE INGREDIENT	9J765S329G	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
LEVOTHYROXINE	ACTIVE MOIETY	Q51BO43MG4	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4
SUCROSE	INACTIVE INGREDIENT	C151H8M554	LEVOTHYROXINE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-1807	LEVOTHYROXINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.]	31	Current NDC, Legacy NDC, 2 package rows	20240801_e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc.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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Cardinal Health 107, LLC	66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076187 application number: ANDA076187
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	db10e666-6204-56cc-e053-2995a90a9e08	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076187 application number: ANDA076187
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	fa15ac73-f4f6-7a6b-e053-6294a90a4f4e	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076187 application number: ANDA076187
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Mylan Institutional Inc.	cd69c192-cd3f-47e6-b0a6-c536ffed5c4b	2025-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076187 application number: ANDA076187
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Mylan Institutional Inc.	5723c7a7-2a1d-4ab6-bf39-b2165ae781a6	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076187 application number: ANDA076187
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Mylan Pharmaceuticals Inc.	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	2024-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076187 application number: ANDA076187 ndc (product): 0378-1807

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	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966248	levothyroxine sodium 112 MCG Oral Tablet	PSN	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966224	levothyroxine sodium 125 MCG Oral Tablet	PSN	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966270	levothyroxine sodium 137 MCG Oral Tablet	PSN	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966225	levothyroxine sodium 150 MCG Oral Tablet	PSN	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966249	levothyroxine sodium 175 MCG Oral Tablet	PSN	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
892251	levothyroxine sodium 200 MCG Oral Tablet	PSN	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966220	levothyroxine sodium 25 MCG Oral Tablet	PSN	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
892255	levothyroxine sodium 300 MCG Oral Tablet	PSN	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966221	levothyroxine sodium 50 MCG Oral Tablet	PSN	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966222	levothyroxine sodium 75 MCG Oral Tablet	PSN	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966253	levothyroxine sodium 88 MCG Oral Tablet	PSN	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966220	levothyroxine sodium 0.025 MG Oral Tablet	SCD	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966221	levothyroxine sodium 0.05 MG Oral Tablet	SCD	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966222	levothyroxine sodium 0.075 MG Oral Tablet	SCD	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966253	levothyroxine sodium 0.088 MG Oral Tablet	SCD	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
892246	levothyroxine sodium 0.1 MG Oral Tablet	SCD	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966248	levothyroxine sodium 0.112 MG Oral Tablet	SCD	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966224	levothyroxine sodium 0.125 MG Oral Tablet	SCD	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966270	levothyroxine sodium 0.137 MG Oral Tablet	SCD	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966225	levothyroxine sodium 0.15 MG Oral Tablet	SCD	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966249	levothyroxine sodium 0.175 MG Oral Tablet	SCD	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
892251	levothyroxine sodium 0.2 MG Oral Tablet	SCD	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
892255	levothyroxine sodium 0.3 MG Oral Tablet	SCD	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
892246	levothyroxine sodium 100 MCG Oral Tablet	SY	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966248	levothyroxine sodium 112 MCG Oral Tablet	SY	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966224	levothyroxine sodium 125 MCG Oral Tablet	SY	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966270	levothyroxine sodium 137 MCG Oral Tablet	SY	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966225	levothyroxine sodium 150 MCG Oral Tablet	SY	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966249	levothyroxine sodium 175 MCG Oral Tablet	SY	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
892251	levothyroxine sodium 200 MCG Oral Tablet	SY	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966220	levothyroxine sodium 25 MCG Oral Tablet	SY	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
892255	levothyroxine sodium 300 MCG Oral Tablet	SY	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966221	levothyroxine sodium 50 MCG Oral Tablet	SY	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966222	levothyroxine sodium 75 MCG Oral Tablet	SY	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966253	levothyroxine sodium 88 MCG Oral Tablet	SY	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	31
966248	levothyroxine sodium 112 MCG Oral Tablet	PSN	cd69c192-cd3f-47e6-b0a6-c536ffed5c4b	11
966270	levothyroxine sodium 137 MCG Oral Tablet	PSN	cd69c192-cd3f-47e6-b0a6-c536ffed5c4b	11
966249	levothyroxine sodium 175 MCG Oral Tablet	PSN	cd69c192-cd3f-47e6-b0a6-c536ffed5c4b	11
966253	levothyroxine sodium 88 MCG Oral Tablet	PSN	cd69c192-cd3f-47e6-b0a6-c536ffed5c4b	11
966253	levothyroxine sodium 0.088 MG Oral Tablet	SCD	cd69c192-cd3f-47e6-b0a6-c536ffed5c4b	11
966248	levothyroxine sodium 0.112 MG Oral Tablet	SCD	cd69c192-cd3f-47e6-b0a6-c536ffed5c4b	11
966270	levothyroxine sodium 0.137 MG Oral Tablet	SCD	cd69c192-cd3f-47e6-b0a6-c536ffed5c4b	11
966249	levothyroxine sodium 0.175 MG Oral Tablet	SCD	cd69c192-cd3f-47e6-b0a6-c536ffed5c4b	11
966248	levothyroxine sodium 112 MCG Oral Tablet	SY	cd69c192-cd3f-47e6-b0a6-c536ffed5c4b	11
966270	levothyroxine sodium 137 MCG Oral Tablet	SY	cd69c192-cd3f-47e6-b0a6-c536ffed5c4b	11
966249	levothyroxine sodium 175 MCG Oral Tablet	SY	cd69c192-cd3f-47e6-b0a6-c536ffed5c4b	11
966253	levothyroxine sodium 88 MCG Oral Tablet	SY	cd69c192-cd3f-47e6-b0a6-c536ffed5c4b	11
892246	levothyroxine sodium 100 MCG Oral Tablet	PSN	40840f67-7066-4bb6-85c1-73eb2618cd26	4
966248	levothyroxine sodium 112 MCG Oral Tablet	PSN	40840f67-7066-4bb6-85c1-73eb2618cd26	4
966220	levothyroxine sodium 25 MCG Oral Tablet	PSN	40840f67-7066-4bb6-85c1-73eb2618cd26	4
966221	levothyroxine sodium 50 MCG Oral Tablet	PSN	40840f67-7066-4bb6-85c1-73eb2618cd26	4
966222	levothyroxine sodium 75 MCG Oral Tablet	PSN	40840f67-7066-4bb6-85c1-73eb2618cd26	4
966253	levothyroxine sodium 88 MCG Oral Tablet	PSN	fa15ac73-f4f6-7a6b-e053-6294a90a4f4e	4
966253	levothyroxine sodium 88 MCG Oral Tablet	PSN	40840f67-7066-4bb6-85c1-73eb2618cd26	4
966220	levothyroxine sodium 0.025 MG Oral Tablet	SCD	40840f67-7066-4bb6-85c1-73eb2618cd26	4
966221	levothyroxine sodium 0.05 MG Oral Tablet	SCD	40840f67-7066-4bb6-85c1-73eb2618cd26	4
966222	levothyroxine sodium 0.075 MG Oral Tablet	SCD	40840f67-7066-4bb6-85c1-73eb2618cd26	4
966253	levothyroxine sodium 0.088 MG Oral Tablet	SCD	40840f67-7066-4bb6-85c1-73eb2618cd26	4
966253	levothyroxine sodium 0.088 MG Oral Tablet	SCD	fa15ac73-f4f6-7a6b-e053-6294a90a4f4e	4
892246	levothyroxine sodium 0.1 MG Oral Tablet	SCD	40840f67-7066-4bb6-85c1-73eb2618cd26	4
966248	levothyroxine sodium 0.112 MG Oral Tablet	SCD	40840f67-7066-4bb6-85c1-73eb2618cd26	4
892246	levothyroxine sodium 100 MCG Oral Tablet	SY	40840f67-7066-4bb6-85c1-73eb2618cd26	4
966248	levothyroxine sodium 112 MCG Oral Tablet	SY	40840f67-7066-4bb6-85c1-73eb2618cd26	4
966220	levothyroxine sodium 25 MCG Oral Tablet	SY	40840f67-7066-4bb6-85c1-73eb2618cd26	4
966221	levothyroxine sodium 50 MCG Oral Tablet	SY	40840f67-7066-4bb6-85c1-73eb2618cd26	4
966222	levothyroxine sodium 75 MCG Oral Tablet	SY	40840f67-7066-4bb6-85c1-73eb2618cd26	4
966253	levothyroxine sodium 88 MCG Oral Tablet	SY	40840f67-7066-4bb6-85c1-73eb2618cd26	4
966253	levothyroxine sodium 88 MCG Oral Tablet	SY	fa15ac73-f4f6-7a6b-e053-6294a90a4f4e	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-1807-04	00378180704	1000 TABLET in 1 BOTTLE, PLASTIC (0378-1807-04)	1000 tablet	2020-07-24	0000-00-00	No	No	Current
0378-1807-10	00378180710	1000 TABLET in 1 BOTTLE, PLASTIC (0378-1807-10)	1000 tablet	2002-11-01	0000-00-00	No	No	Current
0378-1807-77	00378180777	90 TABLET in 1 BOTTLE, PLASTIC (0378-1807-77)	90 tablet	2016-06-27	0000-00-00	No	No	Current
0378-1807-95	00378180795	90 TABLET in 1 BOTTLE, PLASTIC (0378-1807-95)	90 tablet	2020-07-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levothyroxine Sodium	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Levothyroxine Sodium	Mylan Institutional Inc.	2025-07-23	HUMAN PRESCRIPTION DRUG LABEL	11
Levothyroxine Sodium	Mylan Pharmaceuticals Inc.	2024-04-15	HUMAN PRESCRIPTION DRUG LABEL	31
Levothyroxine Sodium - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2012-04-02	HUMAN PRESCRIPTION DRUG LABEL	4