FDA.reportPublic FDA data

Levothyroxine sodium

Product NDC
87063-084
11-digit product format
870630084
Labeler code
87063
Product ID
87063-084_4a23a284-a6e2-10db-e063-6394a90a11cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
ASCLEMED USA INC.
Application
ANDA212399
Marketing category
ANDA
Marketing start
2020-11-25
Substance
LEVOTHYROXINE SODIUM
Active strength
50 ug/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levothyroxine sodium
Listing expiration
2027-12-31

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, 966248, 966249, 966253, 966270

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
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
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87063-084-00Levothyroxine sodium1000 in 1 BOTTLETABLET10001
87063-084-30Levothyroxine sodium30 in 1 BOTTLETABLET301
87063-084-60Levothyroxine sodium60 in 1 BOTTLETABLET601
87063-084-90Levothyroxine sodium90 in 1 BOTTLETABLET901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892246levothyroxine sodium 100 MCG Oral TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966248levothyroxine sodium 112 MCG Oral TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966224levothyroxine sodium 125 MCG Oral TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966270levothyroxine sodium 137 MCG Oral TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966225levothyroxine sodium 150 MCG Oral TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966249levothyroxine sodium 175 MCG Oral TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
892251levothyroxine sodium 200 MCG Oral TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966220levothyroxine sodium 25 MCG Oral TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
892255levothyroxine sodium 300 MCG Oral TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966221levothyroxine sodium 50 MCG Oral TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966222levothyroxine sodium 75 MCG Oral TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966253levothyroxine sodium 88 MCG Oral TabletPSN42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966220levothyroxine sodium 0.025 MG Oral TabletSCD42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966221levothyroxine sodium 0.05 MG Oral TabletSCD42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966222levothyroxine sodium 0.075 MG Oral TabletSCD42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966253levothyroxine sodium 0.088 MG Oral TabletSCD42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
892246levothyroxine sodium 0.1 MG Oral TabletSCD42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966248levothyroxine sodium 0.112 MG Oral TabletSCD42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966224levothyroxine sodium 0.125 MG Oral TabletSCD42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966270levothyroxine sodium 0.137 MG Oral TabletSCD42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966225levothyroxine sodium 0.15 MG Oral TabletSCD42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966249levothyroxine sodium 0.175 MG Oral TabletSCD42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
892251levothyroxine sodium 0.2 MG Oral TabletSCD42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
892255levothyroxine sodium 0.3 MG Oral TabletSCD42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
892246levothyroxine sodium 100 MCG Oral TabletSY42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966248levothyroxine sodium 112 MCG Oral TabletSY42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966224levothyroxine sodium 125 MCG Oral TabletSY42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966270levothyroxine sodium 137 MCG Oral TabletSY42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966225levothyroxine sodium 150 MCG Oral TabletSY42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966249levothyroxine sodium 175 MCG Oral TabletSY42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
892251levothyroxine sodium 200 MCG Oral TabletSY42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966220levothyroxine sodium 25 MCG Oral TabletSY42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
892255levothyroxine sodium 300 MCG Oral TabletSY42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966221levothyroxine sodium 50 MCG Oral TabletSY42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966222levothyroxine sodium 75 MCG Oral TabletSY42a26f8a-dc67-42e4-abb0-d2602afb1b7d1
966253levothyroxine sodium 88 MCG Oral TabletSY42a26f8a-dc67-42e4-abb0-d2602afb1b7d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87063-084-00870630084001000 TABLET in 1 BOTTLE (87063-084-00) 1000 tablet2026-02-06NoNoHistorical
87063-084-308706300843030 TABLET in 1 BOTTLE (87063-084-30) 30 tablet2026-02-06NoNoHistorical
87063-084-608706300846060 TABLET in 1 BOTTLE (87063-084-60) 60 tablet2026-02-06NoNoHistorical
87063-084-908706300849090 TABLET in 1 BOTTLE (87063-084-90) 90 tablet2026-02-06NoNoHistorical