FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
0527-3291
11-digit product format
005273291
Labeler code
0527
Product ID
0527-3291_47e50f93-a701-747e-e063-6294a90a5259
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Lannett Company, Inc
Application
NDA021342
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-08-03
Substance
LEVOTHYROXINE SODIUM
Active strength
300 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 SODIUM300 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
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
0527-3291-43Levothyroxine Sodium1000 in 1 BOTTLETABLET10004
0527-3291-46Levothyroxine Sodium90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-3291-46EA - Each0527-329157b03322-1e82-4d3f-932b-e7a0117b480912020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-3291LEVOTHYROXINE SODIUM TABLET [LANNETT COMPANY, INC]3Current NDC, Legacy NDC, 2 package rows20240103_a8db0f7d-8863-9309-e053-2995a90a284a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892255levothyroxine sodium 300 MCG Oral TabletPSN73c3d459-dcbf-4458-8edd-2637275a96a1103
892255levothyroxine sodium 0.3 MG Oral TabletSCD73c3d459-dcbf-4458-8edd-2637275a96a1103
892255levothyroxine sodium 300 MCG Oral TabletSY73c3d459-dcbf-4458-8edd-2637275a96a1103
892255levothyroxine sodium 300 MCG Oral TabletPSNd0beda93-9454-4846-b5c6-2a9113fb1765101
892255levothyroxine sodium 0.3 MG Oral TabletSCDd0beda93-9454-4846-b5c6-2a9113fb1765101
892255levothyroxine sodium 300 MCG Oral TabletSYd0beda93-9454-4846-b5c6-2a9113fb1765101
892246levothyroxine sodium 100 MCG Oral TabletPSNa8db0f7d-8863-9309-e053-2995a90a284a4
966248levothyroxine sodium 112 MCG Oral TabletPSNa8db0f7d-8863-9309-e053-2995a90a284a4
966224levothyroxine sodium 125 MCG Oral TabletPSNa8db0f7d-8863-9309-e053-2995a90a284a4
966270levothyroxine sodium 137 MCG Oral TabletPSNa8db0f7d-8863-9309-e053-2995a90a284a4
966225levothyroxine sodium 150 MCG Oral TabletPSNa8db0f7d-8863-9309-e053-2995a90a284a4
966249levothyroxine sodium 175 MCG Oral TabletPSNa8db0f7d-8863-9309-e053-2995a90a284a4
892251levothyroxine sodium 200 MCG Oral TabletPSNa8db0f7d-8863-9309-e053-2995a90a284a4
966220levothyroxine sodium 25 MCG Oral TabletPSNa8db0f7d-8863-9309-e053-2995a90a284a4
892255levothyroxine sodium 300 MCG Oral TabletPSNa8db0f7d-8863-9309-e053-2995a90a284a4
966221levothyroxine sodium 50 MCG Oral TabletPSNa8db0f7d-8863-9309-e053-2995a90a284a4
966222levothyroxine sodium 75 MCG Oral TabletPSNa8db0f7d-8863-9309-e053-2995a90a284a4
966253levothyroxine sodium 88 MCG Oral TabletPSNa8db0f7d-8863-9309-e053-2995a90a284a4
966220levothyroxine sodium 0.025 MG Oral TabletSCDa8db0f7d-8863-9309-e053-2995a90a284a4
966221levothyroxine sodium 0.05 MG Oral TabletSCDa8db0f7d-8863-9309-e053-2995a90a284a4
966222levothyroxine sodium 0.075 MG Oral TabletSCDa8db0f7d-8863-9309-e053-2995a90a284a4
966253levothyroxine sodium 0.088 MG Oral TabletSCDa8db0f7d-8863-9309-e053-2995a90a284a4
892246levothyroxine sodium 0.1 MG Oral TabletSCDa8db0f7d-8863-9309-e053-2995a90a284a4
966248levothyroxine sodium 0.112 MG Oral TabletSCDa8db0f7d-8863-9309-e053-2995a90a284a4
966224levothyroxine sodium 0.125 MG Oral TabletSCDa8db0f7d-8863-9309-e053-2995a90a284a4
966270levothyroxine sodium 0.137 MG Oral TabletSCDa8db0f7d-8863-9309-e053-2995a90a284a4
966225levothyroxine sodium 0.15 MG Oral TabletSCDa8db0f7d-8863-9309-e053-2995a90a284a4
966249levothyroxine sodium 0.175 MG Oral TabletSCDa8db0f7d-8863-9309-e053-2995a90a284a4
892251levothyroxine sodium 0.2 MG Oral TabletSCDa8db0f7d-8863-9309-e053-2995a90a284a4
892255levothyroxine sodium 0.3 MG Oral TabletSCDa8db0f7d-8863-9309-e053-2995a90a284a4
892246levothyroxine sodium 100 MCG Oral TabletSYa8db0f7d-8863-9309-e053-2995a90a284a4
966248levothyroxine sodium 112 MCG Oral TabletSYa8db0f7d-8863-9309-e053-2995a90a284a4
966224levothyroxine sodium 125 MCG Oral TabletSYa8db0f7d-8863-9309-e053-2995a90a284a4
966270levothyroxine sodium 137 MCG Oral TabletSYa8db0f7d-8863-9309-e053-2995a90a284a4
966225levothyroxine sodium 150 MCG Oral TabletSYa8db0f7d-8863-9309-e053-2995a90a284a4
966249levothyroxine sodium 175 MCG Oral TabletSYa8db0f7d-8863-9309-e053-2995a90a284a4
892251levothyroxine sodium 200 MCG Oral TabletSYa8db0f7d-8863-9309-e053-2995a90a284a4
966220levothyroxine sodium 25 MCG Oral TabletSYa8db0f7d-8863-9309-e053-2995a90a284a4
892255levothyroxine sodium 300 MCG Oral TabletSYa8db0f7d-8863-9309-e053-2995a90a284a4
966221levothyroxine sodium 50 MCG Oral TabletSYa8db0f7d-8863-9309-e053-2995a90a284a4
966222levothyroxine sodium 75 MCG Oral TabletSYa8db0f7d-8863-9309-e053-2995a90a284a4
966253levothyroxine sodium 88 MCG Oral TabletSYa8db0f7d-8863-9309-e053-2995a90a284a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-3291-43005273291431000 TABLET in 1 BOTTLE (0527-3291-43) 1000 tablet2020-08-030000-00-00NoNoCurrent
0527-3291-460052732914690 TABLET in 1 BOTTLE (0527-3291-46) 90 tablet2020-08-030000-00-00NoNoCurrent