Levothyroxine Sodium

Product NDC: 51655-985
11-digit product format: 516550985
Labeler code: 51655
Product ID: 51655-985_4a28800d-14f1-d841-e063-6394a90a692b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levothyroxine Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA209713
Marketing category: ANDA
Marketing start: 2022-05-04
Substance: LEVOTHYROXINE SODIUM
Active strength: .025 mg/1
Pharmacologic classes: Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
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 · 516 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 38 · 1,500 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209713-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-001	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-001	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-002	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-002	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-003	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-003	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-004	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-004	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-004	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-005	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-005	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-005	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-006	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-006	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-006	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-007	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-007	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-007	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-008	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-008	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-008	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-009	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-009	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-009	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-010	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-010	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-010	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-011	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-011	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-011	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-012	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-012	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-012	AB3	3	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209713-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209713-001	AB2	2	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209713-001	AB3	3	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209713-002	AB1	1	`caaa826d4ba7…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Levothyroxine Sodium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVOTHYROXINE SODIUM	.025 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
966220	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
e0503b8c-7eb7-269e-e053-2995a90a1bca	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
6a33ec05-2ae2-45e5-ab82-2d94b3303923	Product name	1	20190709
93355a10-1c44-4c92-a11d-7d995e0200d9	Product name	1	20190219

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51655-985-52	Levothyroxine Sodium	30 in 1 BOTTLE, PLASTIC	TABLET	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-985	LEVOTHYROXINE SODIUM TABLET [NORTHWIND PHARMACEUTICALS, LLC]	3	Current NDC, Legacy NDC, 1 package rows	20240814_e0503b8c-7eb7-269e-e053-2995a90a1bca.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 3 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	American Health Packaging	38af4e36-b26b-485d-a6f3-7fbcf6072a0f	2025-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	f0680426-3581-400c-8ab5-5e6f18d0cabc	2025-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	b4654497-c986-4792-9b6b-0a791c7c205b	2025-06-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	0e0ad9f1-1f52-48ce-a996-79ebe7ad53cd	2025-06-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	faaa1123-7515-46c2-abbb-b0615540c8cf	2025-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	7f8ec438-8ddf-45d2-be94-ac032e192229	2025-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	f5fc0f34-744c-4e03-ae9f-e017e4033139	2025-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals, Inc.	30ccec8b-3f95-61c7-e063-6394a90a05a0	2025-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Lupin Pharmaceuticals, Inc.	18717e58-89fb-4e2f-93b6-d6ac3e988d37	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	f0a63075-631d-43bf-9d8e-df79faf0a278	2025-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals, Inc.	2cf48978-d996-f5ba-e063-6294a90a8824	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	ddec2148-f97e-4a79-9943-4bef2386a7f2	2025-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals, Inc.	27e98e6d-9fd7-3a94-e063-6394a90a1dcb	2024-12-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals,Inc.	29bb8dbe-f8ba-e2ba-e063-6394a90af38c	2024-12-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	a0ffe111-3574-4481-a732-b68a7d58ef71	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals, Inc.	2646a481-09a5-af6a-e063-6394a90a16da	2024-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	924bb6e9-4b2b-406f-a0a8-376b1f22f1f5	2024-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCarePharmaceuticals, Inc.	2380859a-5b65-f88f-e063-6394a90aa4e2	2024-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	DIRECT RX	a5f15022-1166-09fe-e053-2a95a90aa218	2024-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	804d64c9-9804-4d6d-adb2-5036c0be8b5c	2023-12-12	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
966220	levothyroxine sodium 25 MCG Oral Tablet	PSN	e0503b8c-7eb7-269e-e053-2995a90a1bca	4
966220	levothyroxine sodium 0.025 MG Oral Tablet	SCD	e0503b8c-7eb7-269e-e053-2995a90a1bca	4
966220	levothyroxine sodium 25 MCG Oral Tablet	SY	e0503b8c-7eb7-269e-e053-2995a90a1bca	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51655-985-52	51655098552	30 TABLET in 1 BOTTLE, PLASTIC (51655-985-52)	30 tablet	2022-05-04	0000-00-00	No	No	Current