FDA.reportPublic FDA data

Unithroid

Product NDC
60846-802
11-digit product format
608460802
Labeler code
60846
Product ID
60846-802_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
50 ug/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Unithroid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui892246, 892251, 892255, 966220, 966221, 966222, 966224, 966225, 966228, 966232, 966233, 966235, 966237, 966238, 966241, 966243, 966244, 966246, 966248, 966249

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
60846-802-012024-02-14C16284748780-11030e365-6304-111a-e063-dadaa90a10e2These 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
60846-802-012024-01-30C16284748780-11030e365-6304-111a-e063-dadaa90a10e2These 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 NDCProductDescriptionFormQuantityStrengthSPL version
60846-802-01Unithroid100 in 1 BOTTLETABLET10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60846-802-01EA - Each60846-80239324f17-ae01-45dc-a5c5-f99933d6b80d12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
levothyroxine sodiumACTIVE INGREDIENT9J765S329GUNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]1
levothyroxineACTIVE MOIETYQ51BO43MG4UNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]1
acaciaINACTIVE INGREDIENT5C5403N26OUNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UUNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]1
D&C Red No. 27INACTIVE INGREDIENT2LRS185U6KUNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]1
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GUNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]1
fd&c blue no. 1INACTIVE INGREDIENTH3R47K3TBDUNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]1
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKUNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAUNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]1
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8UNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]1
lactoseINACTIVE INGREDIENTJ2B2A4N98GUNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30UNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4UNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]1
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2UNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]1
starch, cornINACTIVE INGREDIENTO8232NY3SJUNITHROID (LEVOTHYROXINE SODIUM) TABLET [GEMINI LABORATORIES, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60846-802UNITHROID (LEVOTHYROXINE SODIUM) TABLET [AMNEAL PHARMACEUTICALS LLC]13Current NDC, Legacy NDC, 1 package rows20240216_07562e72-7eaa-4ce6-94f0-e08814787e50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892246levothyroxine sodium 100 MCG Oral TabletPSN07562e72-7eaa-4ce6-94f0-e08814787e5013
966248levothyroxine sodium 112 MCG Oral TabletPSN07562e72-7eaa-4ce6-94f0-e08814787e5013
966224levothyroxine sodium 125 MCG Oral TabletPSN07562e72-7eaa-4ce6-94f0-e08814787e5013
966270levothyroxine sodium 137 MCG Oral TabletPSN07562e72-7eaa-4ce6-94f0-e08814787e5013
966225levothyroxine sodium 150 MCG Oral TabletPSN07562e72-7eaa-4ce6-94f0-e08814787e5013
966249levothyroxine sodium 175 MCG Oral TabletPSN07562e72-7eaa-4ce6-94f0-e08814787e5013
892251levothyroxine sodium 200 MCG Oral TabletPSN07562e72-7eaa-4ce6-94f0-e08814787e5013
966220levothyroxine sodium 25 MCG Oral TabletPSN07562e72-7eaa-4ce6-94f0-e08814787e5013
892255levothyroxine sodium 300 MCG Oral TabletPSN07562e72-7eaa-4ce6-94f0-e08814787e5013
966221levothyroxine sodium 50 MCG Oral TabletPSN07562e72-7eaa-4ce6-94f0-e08814787e5013
966222levothyroxine sodium 75 MCG Oral TabletPSN07562e72-7eaa-4ce6-94f0-e08814787e5013
966253levothyroxine sodium 88 MCG Oral TabletPSN07562e72-7eaa-4ce6-94f0-e08814787e5013
966233UNITHROID 100 MCG Oral TabletPSN07562e72-7eaa-4ce6-94f0-e08814787e5013
966235UNITHROID 112 MCG Oral TabletPSN07562e72-7eaa-4ce6-94f0-e08814787e5013
966237UNITHROID 125 MCG Oral TabletPSN07562e72-7eaa-4ce6-94f0-e08814787e5013
966436UNITHROID 137 MCG Oral TabletPSN07562e72-7eaa-4ce6-94f0-e08814787e5013
966238UNITHROID 150 MCG Oral TabletPSN07562e72-7eaa-4ce6-94f0-e08814787e5013
966246UNITHROID 175 MCG Oral TabletPSN07562e72-7eaa-4ce6-94f0-e08814787e5013
966241UNITHROID 200 MCG Oral TabletPSN07562e72-7eaa-4ce6-94f0-e08814787e5013
966228UNITHROID 25 MCG Oral TabletPSN07562e72-7eaa-4ce6-94f0-e08814787e5013
966243UNITHROID 300 MCG Oral TabletPSN07562e72-7eaa-4ce6-94f0-e08814787e5013
966244UNITHROID 50 MCG Oral TabletPSN07562e72-7eaa-4ce6-94f0-e08814787e5013
966286UNITHROID 75 MCG Oral TabletPSN07562e72-7eaa-4ce6-94f0-e08814787e5013
966232UNITHROID 88 MCG Oral TabletPSN07562e72-7eaa-4ce6-94f0-e08814787e5013
966228levothyroxine sodium 0.025 MG Oral Tablet [Unithroid]SBD07562e72-7eaa-4ce6-94f0-e08814787e5013
966244levothyroxine sodium 0.05 MG Oral Tablet [Unithroid]SBD07562e72-7eaa-4ce6-94f0-e08814787e5013
966286levothyroxine sodium 0.075 MG Oral Tablet [Unithroid]SBD07562e72-7eaa-4ce6-94f0-e08814787e5013
966232levothyroxine sodium 0.088 MG Oral Tablet [Unithroid]SBD07562e72-7eaa-4ce6-94f0-e08814787e5013
966233levothyroxine sodium 0.1 MG Oral Tablet [Unithroid]SBD07562e72-7eaa-4ce6-94f0-e08814787e5013
966235levothyroxine sodium 0.112 MG Oral Tablet [Unithroid]SBD07562e72-7eaa-4ce6-94f0-e08814787e5013
966237levothyroxine sodium 0.125 MG Oral Tablet [Unithroid]SBD07562e72-7eaa-4ce6-94f0-e08814787e5013
966436levothyroxine sodium 0.137 MG Oral Tablet [Unithroid]SBD07562e72-7eaa-4ce6-94f0-e08814787e5013
966238levothyroxine sodium 0.15 MG Oral Tablet [Unithroid]SBD07562e72-7eaa-4ce6-94f0-e08814787e5013
966246levothyroxine sodium 0.175 MG Oral Tablet [Unithroid]SBD07562e72-7eaa-4ce6-94f0-e08814787e5013
966241levothyroxine sodium 0.2 MG Oral Tablet [Unithroid]SBD07562e72-7eaa-4ce6-94f0-e08814787e5013
966243levothyroxine sodium 0.3 MG Oral Tablet [Unithroid]SBD07562e72-7eaa-4ce6-94f0-e08814787e5013
966220levothyroxine sodium 0.025 MG Oral TabletSCD07562e72-7eaa-4ce6-94f0-e08814787e5013
966221levothyroxine sodium 0.05 MG Oral TabletSCD07562e72-7eaa-4ce6-94f0-e08814787e5013
966222levothyroxine sodium 0.075 MG Oral TabletSCD07562e72-7eaa-4ce6-94f0-e08814787e5013
966253levothyroxine sodium 0.088 MG Oral TabletSCD07562e72-7eaa-4ce6-94f0-e08814787e5013
892246levothyroxine sodium 0.1 MG Oral TabletSCD07562e72-7eaa-4ce6-94f0-e08814787e5013
966248levothyroxine sodium 0.112 MG Oral TabletSCD07562e72-7eaa-4ce6-94f0-e08814787e5013
966224levothyroxine sodium 0.125 MG Oral TabletSCD07562e72-7eaa-4ce6-94f0-e08814787e5013
966270levothyroxine sodium 0.137 MG Oral TabletSCD07562e72-7eaa-4ce6-94f0-e08814787e5013
966225levothyroxine sodium 0.15 MG Oral TabletSCD07562e72-7eaa-4ce6-94f0-e08814787e5013
966249levothyroxine sodium 0.175 MG Oral TabletSCD07562e72-7eaa-4ce6-94f0-e08814787e5013
892251levothyroxine sodium 0.2 MG Oral TabletSCD07562e72-7eaa-4ce6-94f0-e08814787e5013
892255levothyroxine sodium 0.3 MG Oral TabletSCD07562e72-7eaa-4ce6-94f0-e08814787e5013
892246levothyroxine sodium 100 MCG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966248levothyroxine sodium 112 MCG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966224levothyroxine sodium 125 MCG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966270levothyroxine sodium 137 MCG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966225levothyroxine sodium 150 MCG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966249levothyroxine sodium 175 MCG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
892251levothyroxine sodium 200 MCG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966220levothyroxine sodium 25 MCG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
892255levothyroxine sodium 300 MCG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966221levothyroxine sodium 50 MCG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966222levothyroxine sodium 75 MCG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966253levothyroxine sodium 88 MCG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966228Unithroid 0.025 MG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966244Unithroid 0.05 MG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966286Unithroid 0.075 MG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966232Unithroid 0.088 MG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966233Unithroid 0.1 MG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966235Unithroid 0.112 MG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966237Unithroid 0.125 MG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966436Unithroid 0.137 MG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966238Unithroid 0.15 MG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966246Unithroid 0.175 MG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966241Unithroid 0.2 MG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966243Unithroid 0.3 MG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966233Unithroid 100 MCG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966235Unithroid 112 MCG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966237Unithroid 125 MCG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966436Unithroid 137 MCG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966238Unithroid 150 MCG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966246Unithroid 175 MCG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966241Unithroid 200 MCG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013
966228Unithroid 25 MCG Oral TabletSY07562e72-7eaa-4ce6-94f0-e08814787e5013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60846-802-0160846080201100 TABLET in 1 BOTTLE (60846-802-01) 100 tablet2014-07-030000-00-00NoNoCurrent