LEVOTHYROXINE SODIUM

Manufacturer
DirectRX
Effective date
2015-12-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:22:56

Label at a glance#

ProductLEVOTHYROXINE SODIUM
Active ingredientLEVOTHYROXINE SODIUM
Label structure2 sections

Label contents#

Full prescribing information#

Precautions

PRECAUTIONS SECTION

Precautions section continued

PRECAUTIONS SECTION

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
966253levothyroxine sodium 88 MCG Oral TabletPSN1
966253levothyroxine sodium 0.088 MG Oral TabletSCD1
966253levothyroxine sodium 88 MCG Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LEVOTHYROXINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
97c252d3-9bb8-4530-bb44-9824dc7cf556Product name620250729
6c43b71c-35e6-4db3-ba24-c6ef42ff7003Product name320240207
890fd4bf-1a80-42b7-be1b-2d0259d5f0c8Product name520240207
c8ad26bf-af73-460b-b74e-1eff16cc4f9fProduct name520240207
01383843-4069-43cf-aa76-dc17a6f9f8c4Product name220230123
978cca7d-a938-4791-8322-da48d90a63efProduct name120230113
65f86ba3-8816-4e12-899b-18290c8de551Product name220210614
f16ab90f-08c2-40be-a543-66d9827cd1f3Product name120210601
6a33ec05-2ae2-45e5-ab82-2d94b3303923Product name120190709
93355a10-1c44-4c92-a11d-7d995e0200d9Product name120190219

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-976-302020-07-22C16284748780-1ab0b4bfd-9c8e-d255-e053-dadaa90ae591LEVOTHYROXINE SODIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-976-30LEVOTHYROXINE SODIUM30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-976LEVOTHYROXINE SODIUM TABLET [DIRECTRX]1Legacy NDC, 1 package rows20161014_26042871-1fba-5df6-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-976-30EA - Each61919-9763520d008-2d8c-43b4-bf87-227a6bccd86d12016-11-08
0527-1344-01EA - Each0527-1344f0656054-145f-445b-85a2-c81bfa812e1a12012-07-24
0527-1344-10EA - Each0527-13445190b075-418c-40d0-99c5-171fc5c9e68b12012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61919-97661919-976-30
0527-1344

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021210-001UNITHROIDLEVOTHYROXINE SODIUM0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21
N021210-002UNITHROIDLEVOTHYROXINE SODIUM0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21
N021210-003UNITHROIDLEVOTHYROXINE SODIUM0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21
N021210-004UNITHROIDLEVOTHYROXINE SODIUM0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21
N021210-005UNITHROIDLEVOTHYROXINE SODIUM0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21
N021210-006UNITHROIDLEVOTHYROXINE SODIUM0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21
N021210-007UNITHROIDLEVOTHYROXINE SODIUM0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21
N021210-008UNITHROIDLEVOTHYROXINE SODIUM0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21
N021210-009UNITHROIDLEVOTHYROXINE SODIUM0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21
N021210-010UNITHROIDLEVOTHYROXINE SODIUM0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21
N021210-011UNITHROIDLEVOTHYROXINE SODIUM0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD, RS2000-08-21
N021210-012UNITHROIDLEVOTHYROXINE SODIUM0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2008-02-08

Therapeutic equivalence codes#

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

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021210-001UNITHROID0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-2184e616aacf4f…
2026-09-14 22:38:342026-08N021210-002UNITHROID0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-2184e616aacf4f…
2026-09-14 22:38:342026-08N021210-003UNITHROID0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-2184e616aacf4f…
2026-09-14 22:38:342026-08N021210-004UNITHROID0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-2184e616aacf4f…
2026-09-14 22:38:342026-08N021210-005UNITHROID0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-2184e616aacf4f…
2026-09-14 22:38:342026-08N021210-006UNITHROID0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-2184e616aacf4f…
2026-09-14 22:38:342026-08N021210-007UNITHROID0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-2184e616aacf4f…
2026-09-14 22:38:342026-08N021210-008UNITHROID0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-2184e616aacf4f…
2026-09-14 22:38:342026-08N021210-009UNITHROID0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-2184e616aacf4f…
2026-09-14 22:38:342026-08N021210-010UNITHROID0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-2184e616aacf4f…
2026-09-14 22:38:342026-08N021210-011UNITHROID0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD, RS2000-08-2184e616aacf4f…
2026-09-14 22:38:342026-08N021210-012UNITHROID0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2008-02-0884e616aacf4f…
2026-08-18 06:07:402026-07N021210-001UNITHROID0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07N021210-002UNITHROID0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07N021210-003UNITHROID0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07N021210-004UNITHROID0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07N021210-005UNITHROID0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07N021210-006UNITHROID0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07N021210-007UNITHROID0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07N021210-008UNITHROID0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07N021210-009UNITHROID0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07N021210-010UNITHROID0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07N021210-011UNITHROID0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD, RS2000-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07N021210-012UNITHROID0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2008-02-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021210-001UNITHROID0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-002UNITHROID0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-003UNITHROID0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-004UNITHROID0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-005UNITHROID0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-006UNITHROID0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-007UNITHROID0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-008UNITHROID0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-009UNITHROID0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-010UNITHROID0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-011UNITHROID0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD, RS2000-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021210-012UNITHROID0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2008-02-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021210-001UNITHROID0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021210-002UNITHROID0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021210-003UNITHROID0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021210-004UNITHROID0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3RLD2000-08-2131067a03dcf5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 39 · 1,548 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N021210-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021210-001AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021210-001AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021210-002AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021210-002AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021210-002AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021210-003AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021210-003AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021210-003AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021210-004AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021210-004AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021210-004AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021210-005AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021210-005AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021210-005AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021210-006AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021210-006AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021210-006AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021210-007AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021210-007AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021210-007AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021210-008AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021210-008AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021210-008AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021210-009AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021210-009AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021210-009AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021210-010AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021210-010AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021210-010AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021210-011AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021210-011AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021210-011AB3384e616aacf4f…
2026-09-14 22:38:342026-08N021210-012AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021210-012AB2284e616aacf4f…
2026-09-14 22:38:342026-08N021210-012AB3384e616aacf4f…
2026-08-18 06:07:402026-07N021210-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07N021210-001AB22caaa826d4ba7…
2026-08-18 06:07:402026-07N021210-001AB33caaa826d4ba7…
2026-08-18 06:07:402026-07N021210-002AB11caaa826d4ba7…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
26042871-1fbb-5df6-e054-00144ff8d46c26042871-1fba-5df6-e054-00144ff8d46c2015-12-03Warnings, Adverse reactionsExact identifier
spl id: 26042871-1fbb-5df6-e054-00144ff8d46c
spl set id: 26042871-1fba-5df6-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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