FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
50090-4951
11-digit product format
500904951
Labeler code
50090
Product ID
50090-4951_4ba3b2b8-f1a9-4dd0-a88b-f0f7e7e91980
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209713
Marketing category
ANDA
Marketing start
2019-03-20
Substance
LEVOTHYROXINE SODIUM
Active strength
.088 mg/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 SODIUM.088 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966253

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4951-02023-12-29C16284748780-1f386c64a-0096-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002
50090-4951-12023-12-29C16284748780-1f386c64a-0096-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002
50090-4951-02023-01-30C16284748780-1f386c64a-0096-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002
50090-4951-12023-01-30C16284748780-1f386c64a-0096-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4951-0Levothyroxine Sodium30 in 1 BOTTLETABLET309
50090-4951-1Levothyroxine Sodium90 in 1 BOTTLETABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4951-0EA - Each50090-49515a13119d-5940-4775-8f25-98160b2ffc5b12025-06-13
50090-4951-1EA - Each50090-4951ac0f3312-1927-4b25-ade5-81914e9aec8012025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4951LEVOTHYROXINE SODIUM TABLET [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20250521_7f8ec438-8ddf-45d2-be94-ac032e192229.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966253levothyroxine sodium 88 MCG Oral TabletPSN7f8ec438-8ddf-45d2-be94-ac032e1922299
966253levothyroxine sodium 0.088 MG Oral TabletSCD7f8ec438-8ddf-45d2-be94-ac032e1922299
966253levothyroxine sodium 88 MCG Oral TabletSY7f8ec438-8ddf-45d2-be94-ac032e1922299

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4951-05009049510030 TABLET in 1 BOTTLE (50090-4951-0) 30 tablet2020-03-020000-00-00NoNoCurrent
50090-4951-15009049510190 TABLET in 1 BOTTLE (50090-4951-1) 90 tablet2020-03-020000-00-00NoNoCurrent