FDA.reportPublic FDA data

levothyroxine sodium

Product NDC
47781-646
11-digit product format
477810646
Labeler code
47781
Product ID
47781-646_12e236b4-dc71-96ce-cdd3-7bede41b3f1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Alvogen, Inc.
Application
NDA021116
Marketing category
NDA
Marketing start
2019-05-07
Substance
LEVOTHYROXINE SODIUM
Active strength
75 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 SODIUM75 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
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
47781-646-10levothyroxine sodium1000 in 1 BOTTLETABLET10007
47781-646-90levothyroxine sodium90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-646-10EA - Each47781-6463228f636-fb79-449c-88fc-75752296ab8d12019-06-19
47781-646-90EA - Each47781-646ad2e1291-cb8b-4746-a53e-50b1cfff4ba912019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-646LEVOTHYROXINE SODIUM TABLET [ALVOGEN, INC.]6Current NDC, Legacy NDC, 2 package rows20240317_4ddcaec1-a58f-340b-9bc1-bbe048b8c885.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966222levothyroxine sodium 75 MCG Oral TabletPSNfc803107-aaa2-4753-ab97-7b4ed5cf4be5102
966222levothyroxine sodium 0.075 MG Oral TabletSCDfc803107-aaa2-4753-ab97-7b4ed5cf4be5102
966222levothyroxine sodium 75 MCG Oral TabletSYfc803107-aaa2-4753-ab97-7b4ed5cf4be5102
966222levothyroxine sodium 75 MCG Oral TabletPSN48c29432-a36c-4787-a05f-8d25a0abcc37100
966222levothyroxine sodium 0.075 MG Oral TabletSCD48c29432-a36c-4787-a05f-8d25a0abcc37100
966222levothyroxine sodium 75 MCG Oral TabletSY48c29432-a36c-4787-a05f-8d25a0abcc37100
892246levothyroxine sodium 100 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966248levothyroxine sodium 112 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966224levothyroxine sodium 125 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966270levothyroxine sodium 137 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966225levothyroxine sodium 150 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966249levothyroxine sodium 175 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
892251levothyroxine sodium 200 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966220levothyroxine sodium 25 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966221levothyroxine sodium 50 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966222levothyroxine sodium 75 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966253levothyroxine sodium 88 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966220levothyroxine sodium 0.025 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966221levothyroxine sodium 0.05 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966222levothyroxine sodium 0.075 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966253levothyroxine sodium 0.088 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
892246levothyroxine sodium 0.1 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966248levothyroxine sodium 0.112 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966224levothyroxine sodium 0.125 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966270levothyroxine sodium 0.137 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966225levothyroxine sodium 0.15 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966249levothyroxine sodium 0.175 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
892251levothyroxine sodium 0.2 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
892246levothyroxine sodium 100 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966248levothyroxine sodium 112 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966224levothyroxine sodium 125 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966270levothyroxine sodium 137 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966225levothyroxine sodium 150 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966249levothyroxine sodium 175 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
892251levothyroxine sodium 200 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966220levothyroxine sodium 25 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966221levothyroxine sodium 50 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966222levothyroxine sodium 75 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966253levothyroxine sodium 88 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
892246levothyroxine sodium 100 MCG Oral TabletPSNa5f15022-1166-09fe-e053-2a95a90aa21821
966248levothyroxine sodium 112 MCG Oral TabletPSNa5f15022-1166-09fe-e053-2a95a90aa21821
966224levothyroxine sodium 125 MCG Oral TabletPSNa5f15022-1166-09fe-e053-2a95a90aa21821
966270levothyroxine sodium 137 MCG Oral TabletPSNa5f15022-1166-09fe-e053-2a95a90aa21821
966225levothyroxine sodium 150 MCG Oral TabletPSNa5f15022-1166-09fe-e053-2a95a90aa21821
966220levothyroxine sodium 25 MCG Oral TabletPSNa5f15022-1166-09fe-e053-2a95a90aa21821
966221levothyroxine sodium 50 MCG Oral TabletPSNa5f15022-1166-09fe-e053-2a95a90aa21821
966222levothyroxine sodium 75 MCG Oral TabletPSNa5f15022-1166-09fe-e053-2a95a90aa21821
966253levothyroxine sodium 88 MCG Oral TabletPSNa5f15022-1166-09fe-e053-2a95a90aa21821
966220levothyroxine sodium 0.025 MG Oral TabletSCDa5f15022-1166-09fe-e053-2a95a90aa21821
966221levothyroxine sodium 0.05 MG Oral TabletSCDa5f15022-1166-09fe-e053-2a95a90aa21821
966222levothyroxine sodium 0.075 MG Oral TabletSCDa5f15022-1166-09fe-e053-2a95a90aa21821
966253levothyroxine sodium 0.088 MG Oral TabletSCDa5f15022-1166-09fe-e053-2a95a90aa21821
892246levothyroxine sodium 0.1 MG Oral TabletSCDa5f15022-1166-09fe-e053-2a95a90aa21821
966248levothyroxine sodium 0.112 MG Oral TabletSCDa5f15022-1166-09fe-e053-2a95a90aa21821
966224levothyroxine sodium 0.125 MG Oral TabletSCDa5f15022-1166-09fe-e053-2a95a90aa21821
966270levothyroxine sodium 0.137 MG Oral TabletSCDa5f15022-1166-09fe-e053-2a95a90aa21821
966225levothyroxine sodium 0.15 MG Oral TabletSCDa5f15022-1166-09fe-e053-2a95a90aa21821
892246levothyroxine sodium 100 MCG Oral TabletSYa5f15022-1166-09fe-e053-2a95a90aa21821
966248levothyroxine sodium 112 MCG Oral TabletSYa5f15022-1166-09fe-e053-2a95a90aa21821
966224levothyroxine sodium 125 MCG Oral TabletSYa5f15022-1166-09fe-e053-2a95a90aa21821
966270levothyroxine sodium 137 MCG Oral TabletSYa5f15022-1166-09fe-e053-2a95a90aa21821
966225levothyroxine sodium 150 MCG Oral TabletSYa5f15022-1166-09fe-e053-2a95a90aa21821
966220levothyroxine sodium 25 MCG Oral TabletSYa5f15022-1166-09fe-e053-2a95a90aa21821
966221levothyroxine sodium 50 MCG Oral TabletSYa5f15022-1166-09fe-e053-2a95a90aa21821
966222levothyroxine sodium 75 MCG Oral TabletSYa5f15022-1166-09fe-e053-2a95a90aa21821
966253levothyroxine sodium 88 MCG Oral TabletSYa5f15022-1166-09fe-e053-2a95a90aa21821
892246levothyroxine sodium 100 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966248levothyroxine sodium 112 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966224levothyroxine sodium 125 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966270levothyroxine sodium 137 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966225levothyroxine sodium 150 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966249levothyroxine sodium 175 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
892251levothyroxine sodium 200 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966220levothyroxine sodium 25 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
892255levothyroxine sodium 300 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966221levothyroxine sodium 50 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966222levothyroxine sodium 75 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966222levothyroxine sodium 75 MCG Oral TabletPSNac10b751-5195-4987-a841-400ae79730f07
966253levothyroxine sodium 88 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966220levothyroxine sodium 0.025 MG Oral TabletSCD4ddcaec1-a58f-340b-9bc1-bbe048b8c8857

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47781-646-10477810646101000 TABLET in 1 BOTTLE (47781-646-10) 1000 tablet2019-05-070000-00-00NoNoCurrent
47781-646-904778106469090 TABLET in 1 BOTTLE (47781-646-90) 90 tablet2019-05-070000-00-00NoNoCurrent