FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
42292-038
11-digit product format
422920038
Labeler code
42292
Product ID
42292-038_3a991bf1-d9aa-b137-e063-6294a90af2cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA076187
Marketing category
ANDA
Marketing start
2017-01-18
Substance
LEVOTHYROXINE SODIUM
Active strength
88 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
Levothyroxine Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM88 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966248, 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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42292-038-01Levothyroxine Sodium1 in 1 BLISTER PACKTABLET111
42292-038-20Levothyroxine Sodium100 in 1 CARTONTABLET10011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42292-038LEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]10Current NDC, Legacy NDC, 2 package rows20241006_cd69c192-cd3f-47e6-b0a6-c536ffed5c4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966248levothyroxine sodium 112 MCG Oral TabletPSNcd69c192-cd3f-47e6-b0a6-c536ffed5c4b11
966270levothyroxine sodium 137 MCG Oral TabletPSNcd69c192-cd3f-47e6-b0a6-c536ffed5c4b11
966249levothyroxine sodium 175 MCG Oral TabletPSNcd69c192-cd3f-47e6-b0a6-c536ffed5c4b11
966253levothyroxine sodium 88 MCG Oral TabletPSNcd69c192-cd3f-47e6-b0a6-c536ffed5c4b11
966253levothyroxine sodium 0.088 MG Oral TabletSCDcd69c192-cd3f-47e6-b0a6-c536ffed5c4b11
966248levothyroxine sodium 0.112 MG Oral TabletSCDcd69c192-cd3f-47e6-b0a6-c536ffed5c4b11
966270levothyroxine sodium 0.137 MG Oral TabletSCDcd69c192-cd3f-47e6-b0a6-c536ffed5c4b11
966249levothyroxine sodium 0.175 MG Oral TabletSCDcd69c192-cd3f-47e6-b0a6-c536ffed5c4b11
966248levothyroxine sodium 112 MCG Oral TabletSYcd69c192-cd3f-47e6-b0a6-c536ffed5c4b11
966270levothyroxine sodium 137 MCG Oral TabletSYcd69c192-cd3f-47e6-b0a6-c536ffed5c4b11
966249levothyroxine sodium 175 MCG Oral TabletSYcd69c192-cd3f-47e6-b0a6-c536ffed5c4b11
966253levothyroxine sodium 88 MCG Oral TabletSYcd69c192-cd3f-47e6-b0a6-c536ffed5c4b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42292-038-01422920038011 in 1 BLISTER PACKHistorical
42292-038-2042292003820100 BLISTER PACK in 1 CARTON (42292-038-20) / 1 TABLET in 1 BLISTER PACK (42292-038-01) 100 blister pack2017-01-180000-00-00NoNoCurrent