FDA.reportPublic FDA data

LEVOXYL

Product NDC
60793-850
11-digit product format
607930850
Labeler code
60793
Product ID
60793-850_e230c170-2a16-47d0-bce7-ac0414c192f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA021301
Marketing category
NDA
Marketing start
2001-05-25
Substance
LEVOTHYROXINE SODIUM
Active strength
25 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
LEVOXYL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM25 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui892246, 892251, 966157, 966164, 966170, 966175, 966184, 966190, 966194, 966200, 966204, 966211, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 966253

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
97c252d3-9bb8-4530-bb44-9824dc7cf556Product name620250729
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
6c43b71c-35e6-4db3-ba24-c6ef42ff7003Product name320240207
890fd4bf-1a80-42b7-be1b-2d0259d5f0c8Product name520240207
c8ad26bf-af73-460b-b74e-1eff16cc4f9fProduct name520240207
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
01383843-4069-43cf-aa76-dc17a6f9f8c4Product name220230123
978cca7d-a938-4791-8322-da48d90a63efProduct name120230113
65f86ba3-8816-4e12-899b-18290c8de551Product name220210614
f16ab90f-08c2-40be-a543-66d9827cd1f3Product name120210601
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
6a33ec05-2ae2-45e5-ab82-2d94b3303923Product name120190709
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
93355a10-1c44-4c92-a11d-7d995e0200d9Product name120190219
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60793-850-01LEVOXYL100 in 1 BOTTLETABLET10012
60793-850-10LEVOXYL1000 in 1 BOTTLETABLET100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60793-850-01EA - Each60793-850d65162ab-cb36-4651-b696-1da0192f35f612012-07-24
60793-850-10EA - Each60793-8502388b09c-b47c-409a-8c08-6a3015d4510112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOTHYROXINE SODIUMACTIVE INGREDIENT9J765S329GLEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PFIZER LABORATORIES DIV PFIZER INC]7
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PFIZER LABORATORIES DIV PFIZER INC]7
LEVOTHYROXINE SODIUMACTIVE INGREDIENT9J765S329GLEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
CALCIUM SULFATE DIHYDRATEINACTIVE INGREDIENT4846Q921YMLEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BLEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOLEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60793-850LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PFIZER LABORATORIES DIV PFIZER INC]12Current NDC, Legacy NDC, 2 package rows20201216_758588c3-c63e-491b-0aa2-4f50d80cb174.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892246levothyroxine sodium 100 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966248levothyroxine sodium 112 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966224levothyroxine sodium 125 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966270levothyroxine sodium 137 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966225levothyroxine sodium 150 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966249levothyroxine sodium 175 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
892251levothyroxine sodium 200 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966220levothyroxine sodium 25 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966221levothyroxine sodium 50 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966222levothyroxine sodium 75 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966253levothyroxine sodium 88 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966283LEVOXYL 100 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966184LEVOXYL 112 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966190LEVOXYL 125 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966194LEVOXYL 137 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966200LEVOXYL 150 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966204LEVOXYL 175 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966211LEVOXYL 200 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966157LEVOXYL 25 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966164LEVOXYL 50 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966170LEVOXYL 75 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966175LEVOXYL 88 MCG Oral TabletPSN758588c3-c63e-491b-0aa2-4f50d80cb17412
966157levothyroxine sodium 0.025 MG Oral Tablet [Levoxyl]SBD758588c3-c63e-491b-0aa2-4f50d80cb17412
966164levothyroxine sodium 0.05 MG Oral Tablet [Levoxyl]SBD758588c3-c63e-491b-0aa2-4f50d80cb17412
966170levothyroxine sodium 0.075 MG Oral Tablet [Levoxyl]SBD758588c3-c63e-491b-0aa2-4f50d80cb17412
966175levothyroxine sodium 0.088 MG Oral Tablet [Levoxyl]SBD758588c3-c63e-491b-0aa2-4f50d80cb17412
966283levothyroxine sodium 0.1 MG Oral Tablet [Levoxyl]SBD758588c3-c63e-491b-0aa2-4f50d80cb17412
966184levothyroxine sodium 0.112 MG Oral Tablet [Levoxyl]SBD758588c3-c63e-491b-0aa2-4f50d80cb17412
966190levothyroxine sodium 0.125 MG Oral Tablet [Levoxyl]SBD758588c3-c63e-491b-0aa2-4f50d80cb17412
966194levothyroxine sodium 0.137 MG Oral Tablet [Levoxyl]SBD758588c3-c63e-491b-0aa2-4f50d80cb17412
966200levothyroxine sodium 0.15 MG Oral Tablet [Levoxyl]SBD758588c3-c63e-491b-0aa2-4f50d80cb17412
966204levothyroxine sodium 0.175 MG Oral Tablet [Levoxyl]SBD758588c3-c63e-491b-0aa2-4f50d80cb17412
966211levothyroxine sodium 0.2 MG Oral Tablet [Levoxyl]SBD758588c3-c63e-491b-0aa2-4f50d80cb17412
966220levothyroxine sodium 0.025 MG Oral TabletSCD758588c3-c63e-491b-0aa2-4f50d80cb17412
966221levothyroxine sodium 0.05 MG Oral TabletSCD758588c3-c63e-491b-0aa2-4f50d80cb17412
966222levothyroxine sodium 0.075 MG Oral TabletSCD758588c3-c63e-491b-0aa2-4f50d80cb17412
966253levothyroxine sodium 0.088 MG Oral TabletSCD758588c3-c63e-491b-0aa2-4f50d80cb17412
892246levothyroxine sodium 0.1 MG Oral TabletSCD758588c3-c63e-491b-0aa2-4f50d80cb17412
966248levothyroxine sodium 0.112 MG Oral TabletSCD758588c3-c63e-491b-0aa2-4f50d80cb17412
966224levothyroxine sodium 0.125 MG Oral TabletSCD758588c3-c63e-491b-0aa2-4f50d80cb17412
966270levothyroxine sodium 0.137 MG Oral TabletSCD758588c3-c63e-491b-0aa2-4f50d80cb17412
966225levothyroxine sodium 0.15 MG Oral TabletSCD758588c3-c63e-491b-0aa2-4f50d80cb17412
966249levothyroxine sodium 0.175 MG Oral TabletSCD758588c3-c63e-491b-0aa2-4f50d80cb17412
892251levothyroxine sodium 0.2 MG Oral TabletSCD758588c3-c63e-491b-0aa2-4f50d80cb17412
892246levothyroxine sodium 100 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966248levothyroxine sodium 112 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966224levothyroxine sodium 125 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966270levothyroxine sodium 137 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966225levothyroxine sodium 150 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966249levothyroxine sodium 175 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
892251levothyroxine sodium 200 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966220levothyroxine sodium 25 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966221levothyroxine sodium 50 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966222levothyroxine sodium 75 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966253levothyroxine sodium 88 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966157Levoxyl 0.025 MG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966164Levoxyl 0.05 MG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966170Levoxyl 0.075 MG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966175Levoxyl 0.088 MG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966283Levoxyl 0.1 MG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966184Levoxyl 0.112 MG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966190Levoxyl 0.125 MG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966194Levoxyl 0.137 MG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966200Levoxyl 0.15 MG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966204Levoxyl 0.175 MG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966211Levoxyl 0.2 MG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966283Levoxyl 100 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966184Levoxyl 112 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966190Levoxyl 125 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966194Levoxyl 137 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966200Levoxyl 150 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966204Levoxyl 175 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966211Levoxyl 200 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966157Levoxyl 25 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966164Levoxyl 50 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966170Levoxyl 75 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
966175Levoxyl 88 MCG Oral TabletSY758588c3-c63e-491b-0aa2-4f50d80cb17412
892246levothyroxine sodium 100 MCG Oral TabletPSN951c6e16-7251-42ed-ac19-d8367a6aee4f5
966248levothyroxine sodium 112 MCG Oral TabletPSN951c6e16-7251-42ed-ac19-d8367a6aee4f5
966224levothyroxine sodium 125 MCG Oral TabletPSN951c6e16-7251-42ed-ac19-d8367a6aee4f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60793-850-0160793085001100 TABLET in 1 BOTTLE (60793-850-01) 100 tablet2001-05-250000-00-00NoNoCurrent
60793-850-10607930850101000 TABLET in 1 BOTTLE (60793-850-10) 1000 tablet2001-05-250000-00-00NoNoCurrent