Unithroid

Product NDC: 60846-805
11-digit product format: 608460805
Labeler code: 60846
Product ID: 60846-805_35a7647b-9644-4c4c-8011-a0d5969c0a56
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levothyroxine sodium
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: NDA021210
Marketing category: NDA
Marketing start: 2014-07-03
Substance: LEVOTHYROXINE SODIUM
Active strength: 100 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 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	RLD / RS	Approval date
N021210-001	UNITHROID	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-002	UNITHROID	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-003	UNITHROID	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-004	UNITHROID	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-005	UNITHROID	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-006	UNITHROID	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-007	UNITHROID	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-008	UNITHROID	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-009	UNITHROID	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-010	UNITHROID	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21
N021210-011	UNITHROID	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD, RS	2000-08-21
N021210-012	UNITHROID	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2008-02-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021210-001	AB1
N021210-001	AB2
N021210-001	AB3
N021210-002	AB1
N021210-002	AB2
N021210-002	AB3
N021210-003	AB1
N021210-003	AB2
N021210-003	AB3
N021210-004	AB1
N021210-004	AB2
N021210-004	AB3
N021210-005	AB1
N021210-005	AB2
N021210-005	AB3
N021210-006	AB1
N021210-006	AB2
N021210-006	AB3
N021210-007	AB1
N021210-007	AB2
N021210-007	AB3
N021210-008	AB1
N021210-008	AB2
N021210-008	AB3
N021210-009	AB1
N021210-009	AB2
N021210-009	AB3
N021210-010	AB1
N021210-010	AB2
N021210-010	AB3
N021210-011	AB1
N021210-011	AB2
N021210-011	AB3
N021210-012	AB1
N021210-012	AB2
N021210-012	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021210-001	UNITHROID	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-002	UNITHROID	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-003	UNITHROID	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-004	UNITHROID	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-005	UNITHROID	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-006	UNITHROID	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-007	UNITHROID	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-008	UNITHROID	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-009	UNITHROID	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-010	UNITHROID	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-011	UNITHROID	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD, RS	2000-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-012	UNITHROID	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2008-02-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021210-001	UNITHROID	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-002	UNITHROID	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-003	UNITHROID	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-004	UNITHROID	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-005	UNITHROID	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-006	UNITHROID	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-007	UNITHROID	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-008	UNITHROID	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-009	UNITHROID	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-010	UNITHROID	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-011	UNITHROID	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD, RS	2000-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-012	UNITHROID	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2008-02-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021210-001	UNITHROID	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-002	UNITHROID	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-003	UNITHROID	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-004	UNITHROID	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-005	UNITHROID	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-006	UNITHROID	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-007	UNITHROID	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-008	UNITHROID	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-009	UNITHROID	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-010	UNITHROID	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-011	UNITHROID	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD, RS	2000-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021210-012	UNITHROID	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2008-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021210-001	UNITHROID	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021210-002	UNITHROID	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021210-003	UNITHROID	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021210-004	UNITHROID	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	RLD	2000-08-21	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 39 · 1,548 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	N021210-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-001	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-001	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-002	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-002	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-003	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-003	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-004	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-004	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-004	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-005	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-005	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-005	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-006	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-006	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-006	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-007	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-007	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-007	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-008	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-008	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-008	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-009	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-009	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-009	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-010	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-010	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-010	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-011	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-011	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-011	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-012	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-012	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021210-012	AB3	3	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021210-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-001	AB2	2	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-001	AB3	3	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021210-002	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: Unithroid
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 2 · 24 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
966228	Internal RxNorm lookup
966232	Internal RxNorm lookup
966233	Internal RxNorm lookup
966235	Internal RxNorm lookup
966237	Internal RxNorm lookup
966238	Internal RxNorm lookup
966241	Internal RxNorm lookup
966243	Internal RxNorm lookup
966244	Internal RxNorm lookup
966246	Internal RxNorm lookup
966248	Internal RxNorm lookup
966249	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
07562e72-7eaa-4ce6-94f0-e08814787e50	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60846-805-01	2024-02-14	C162847	48780-1	1030e365-6304-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use UNITHROID safely and effectively. See full prescribing information for UNITHROID. UNITHROID ® (levothyroxine sodium) tablets, for oral use Initial U.S. Approval: 2001
60846-805-01	2024-01-30	C162847	48780-1	1030e365-6304-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use UNITHROID safely and effectively. See full prescribing information for UNITHROID. UNITHROID ® (levothyroxine sodium) tablets, for oral use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60846-805-01	Unithroid	100 in 1 BOTTLE	TABLET	100		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60846-805-01	EA - Each	60846-805	46b5df2e-66f0-4c7d-b04d-a5fc428ed2d1	1	2014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
levothyroxine sodium	ACTIVE INGREDIENT	9J765S329G	UNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]	1
levothyroxine	ACTIVE MOIETY	Q51BO43MG4	UNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]	1
acacia	INACTIVE INGREDIENT	5C5403N26O	UNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	UNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]	1
D&C Red No. 27	INACTIVE INGREDIENT	2LRS185U6K	UNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]	1
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	UNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]	1
fd&c blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	UNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]	1
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	UNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]	1
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	UNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]	1
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	UNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]	1
lactose	INACTIVE INGREDIENT	J2B2A4N98G	UNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	UNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	UNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]	1
sodium starch glycolate type a potato	INACTIVE INGREDIENT	5856J3G2A2	UNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	UNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60846-805	UNITHROID (LEVOTHYROXINE SODIUM) TABLET [AMNEAL PHARMACEUTICALS LLC]	13	Current NDC, Legacy NDC, 1 package rows	20240216_07562e72-7eaa-4ce6-94f0-e08814787e50.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	abe173cc-1579-43a5-b12d-a31958d0a539	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	c968836a-f94c-4d13-e053-2995a90a8df5	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Amneal Pharmaceuticals NY LLC	fca88c97-5cd4-4834-ba87-deb5bd637788	2024-12-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	2f0657d5-3e5c-4249-bfaa-7f5ef1528672	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	97e28b00-9913-463f-9de2-08c828edbe67	2020-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	05ab038e-45fa-488e-a05e-12a2dd3564c1	2020-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	b81720f9-2836-4c1d-8691-0f6acef13316	2020-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	434075d5-a82b-4f17-85e6-4c1922663dbc	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	18c7c63a-642e-47fe-a8ee-12aaf652b2aa	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210
Unithroid	LEVOTHYROXINE SODIUM	Amneal Pharmaceuticals LLC	07562e72-7eaa-4ce6-94f0-e08814787e50	2019-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021210 application number: NDA021210 ndc (product): 60846-805

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	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966248	levothyroxine sodium 112 MCG Oral Tablet	PSN	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966224	levothyroxine sodium 125 MCG Oral Tablet	PSN	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966270	levothyroxine sodium 137 MCG Oral Tablet	PSN	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966225	levothyroxine sodium 150 MCG Oral Tablet	PSN	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966249	levothyroxine sodium 175 MCG Oral Tablet	PSN	07562e72-7eaa-4ce6-94f0-e08814787e50	13
892251	levothyroxine sodium 200 MCG Oral Tablet	PSN	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966220	levothyroxine sodium 25 MCG Oral Tablet	PSN	07562e72-7eaa-4ce6-94f0-e08814787e50	13
892255	levothyroxine sodium 300 MCG Oral Tablet	PSN	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966221	levothyroxine sodium 50 MCG Oral Tablet	PSN	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966222	levothyroxine sodium 75 MCG Oral Tablet	PSN	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966253	levothyroxine sodium 88 MCG Oral Tablet	PSN	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966233	UNITHROID 100 MCG Oral Tablet	PSN	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966235	UNITHROID 112 MCG Oral Tablet	PSN	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966237	UNITHROID 125 MCG Oral Tablet	PSN	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966436	UNITHROID 137 MCG Oral Tablet	PSN	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966238	UNITHROID 150 MCG Oral Tablet	PSN	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966246	UNITHROID 175 MCG Oral Tablet	PSN	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966241	UNITHROID 200 MCG Oral Tablet	PSN	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966228	UNITHROID 25 MCG Oral Tablet	PSN	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966243	UNITHROID 300 MCG Oral Tablet	PSN	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966244	UNITHROID 50 MCG Oral Tablet	PSN	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966286	UNITHROID 75 MCG Oral Tablet	PSN	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966232	UNITHROID 88 MCG Oral Tablet	PSN	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966228	levothyroxine sodium 0.025 MG Oral Tablet [Unithroid]	SBD	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966244	levothyroxine sodium 0.05 MG Oral Tablet [Unithroid]	SBD	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966286	levothyroxine sodium 0.075 MG Oral Tablet [Unithroid]	SBD	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966232	levothyroxine sodium 0.088 MG Oral Tablet [Unithroid]	SBD	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966233	levothyroxine sodium 0.1 MG Oral Tablet [Unithroid]	SBD	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966235	levothyroxine sodium 0.112 MG Oral Tablet [Unithroid]	SBD	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966237	levothyroxine sodium 0.125 MG Oral Tablet [Unithroid]	SBD	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966436	levothyroxine sodium 0.137 MG Oral Tablet [Unithroid]	SBD	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966238	levothyroxine sodium 0.15 MG Oral Tablet [Unithroid]	SBD	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966246	levothyroxine sodium 0.175 MG Oral Tablet [Unithroid]	SBD	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966241	levothyroxine sodium 0.2 MG Oral Tablet [Unithroid]	SBD	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966243	levothyroxine sodium 0.3 MG Oral Tablet [Unithroid]	SBD	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966220	levothyroxine sodium 0.025 MG Oral Tablet	SCD	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966221	levothyroxine sodium 0.05 MG Oral Tablet	SCD	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966222	levothyroxine sodium 0.075 MG Oral Tablet	SCD	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966253	levothyroxine sodium 0.088 MG Oral Tablet	SCD	07562e72-7eaa-4ce6-94f0-e08814787e50	13
892246	levothyroxine sodium 0.1 MG Oral Tablet	SCD	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966248	levothyroxine sodium 0.112 MG Oral Tablet	SCD	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966224	levothyroxine sodium 0.125 MG Oral Tablet	SCD	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966270	levothyroxine sodium 0.137 MG Oral Tablet	SCD	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966225	levothyroxine sodium 0.15 MG Oral Tablet	SCD	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966249	levothyroxine sodium 0.175 MG Oral Tablet	SCD	07562e72-7eaa-4ce6-94f0-e08814787e50	13
892251	levothyroxine sodium 0.2 MG Oral Tablet	SCD	07562e72-7eaa-4ce6-94f0-e08814787e50	13
892255	levothyroxine sodium 0.3 MG Oral Tablet	SCD	07562e72-7eaa-4ce6-94f0-e08814787e50	13
892246	levothyroxine sodium 100 MCG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966248	levothyroxine sodium 112 MCG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966224	levothyroxine sodium 125 MCG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966270	levothyroxine sodium 137 MCG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966225	levothyroxine sodium 150 MCG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966249	levothyroxine sodium 175 MCG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
892251	levothyroxine sodium 200 MCG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966220	levothyroxine sodium 25 MCG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
892255	levothyroxine sodium 300 MCG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966221	levothyroxine sodium 50 MCG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966222	levothyroxine sodium 75 MCG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966253	levothyroxine sodium 88 MCG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966228	Unithroid 0.025 MG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966244	Unithroid 0.05 MG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966286	Unithroid 0.075 MG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966232	Unithroid 0.088 MG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966233	Unithroid 0.1 MG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966235	Unithroid 0.112 MG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966237	Unithroid 0.125 MG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966436	Unithroid 0.137 MG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966238	Unithroid 0.15 MG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966246	Unithroid 0.175 MG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966241	Unithroid 0.2 MG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966243	Unithroid 0.3 MG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966233	Unithroid 100 MCG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966235	Unithroid 112 MCG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966237	Unithroid 125 MCG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966436	Unithroid 137 MCG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966238	Unithroid 150 MCG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966246	Unithroid 175 MCG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966241	Unithroid 200 MCG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13
966228	Unithroid 25 MCG Oral Tablet	SY	07562e72-7eaa-4ce6-94f0-e08814787e50	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60846-805-01	60846080501	100 TABLET in 1 BOTTLE (60846-805-01)	100 tablet	2014-07-03	0000-00-00	No	No	Current