Levothyroxine Sodium

Product NDC: 50436-5501
11-digit product format: 504365501
Labeler code: 50436
Product ID: 50436-5501_16626b29-36c7-4fd9-949e-65cbcef62728
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levothyroxine Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Unit Dose Services
Application: NDA021210
Marketing category: NDA
Marketing start: 2003-12-01
Marketing end: 0000-00-00
Substance: LEVOTHYROXINE SODIUM ANHYDROUS
Active strength: 0 mg/1
Pharmacologic classes: l-Thyroxine [EPC],Thyroxine [CS]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50436-5501		I	Inactivated by FDA	2026-07-31
excluded package	package	50436-5501	50436-5501-2	I	Inactivated by FDA	2026-07-31
excluded package	package	50436-5501	50436-5501-3	I	Inactivated by FDA	2026-07-31

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
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.

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
2026-08-01 22:54:32	2026-06	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	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	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	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	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	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	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	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	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	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	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	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	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	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	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	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	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	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	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	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	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	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	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	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N021210-001	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-001	AB2	2	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-001	AB3	3	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-002	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-002	AB2	2	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-002	AB3	3	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-003	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-003	AB2	2	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-003	AB3	3	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-004	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-004	AB2	2	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-004	AB3	3	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-005	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-005	AB2	2	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-005	AB3	3	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-006	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-006	AB2	2	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-006	AB3	3	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-007	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-007	AB2	2	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-007	AB3	3	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-008	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-008	AB2	2	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-008	AB3	3	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-009	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-009	AB2	2	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-009	AB3	3	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-010	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-010	AB2	2	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-010	AB3	3	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-011	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-011	AB2	2	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-011	AB3	3	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-012	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-012	AB2	2	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021210-012	AB3	3	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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
50436-5501-2	2020-01-31	C162847	48780-1	9d75b9d0-0028-f424-e053-dadaa90a57ce	Levothyroxine Sodium Tablets, USP
50436-5501-3	2020-01-31	C162847	48780-1	9d75b9d0-0028-f424-e053-dadaa90a57ce	Levothyroxine Sodium Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-5501-2	Levothyroxine Sodium	30 in 1 BOTTLE	TABLET	30		2
50436-5501-3	Levothyroxine Sodium	90 in 1 BOTTLE	TABLET	90		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOTHYROXINE SODIUM ANHYDROUS	ACTIVE INGREDIENT	054I36CPMN	LEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]	2
LEVOTHYROXINE	ACTIVE MOIETY	Q51BO43MG4	LEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]	2
ACACIA	INACTIVE INGREDIENT	5C5403N26O	LEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	LEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]	2
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	LEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	LEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-5501	LEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]	2	Legacy NDC, 2 package rows	20131007_ac83ac72-b447-47df-b6ad-94537305b7b8.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
054I36CPMN	LEVOTHYROXINE SODIUM ANHYDROUS	55-03-8	LEVOTHYROXINE SODIUM ANHYDROUS
9J765S329G	LEVOTHYROXINE SODIUM	6106-07-6	Levothyroxine Sodium

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
966248	levothyroxine sodium 112 MCG Oral Tablet	PSN	ac83ac72-b447-47df-b6ad-94537305b7b8	2
966248	levothyroxine sodium 0.112 MG Oral Tablet	SCD	ac83ac72-b447-47df-b6ad-94537305b7b8	2
966248	levothyroxine sodium 112 MCG Oral Tablet	SY	ac83ac72-b447-47df-b6ad-94537305b7b8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-5501-2	50436550102	30 in 1 BOTTLE	Historical
50436-5501-3	50436550103	90 in 1 BOTTLE	Historical