FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
50090-6982
11-digit product format
500906982
Labeler code
50090
Product ID
50090-6982_48fee4f7-f275-45cf-8d4e-ad207cf91b23
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
.125 mg/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 SODIUM.125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966224

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
50090-6982-0Levothyroxine Sodium30 in 1 BOTTLETABLET309
50090-6982-1Levothyroxine Sodium90 in 1 BOTTLETABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6982-0EA - Each50090-6982532ca8c0-7614-4d20-a2b6-8a6b21a30b3612024-02-14
50090-6982-1EA - Each50090-69826f035a2b-177b-4987-a1a4-475d43b62ea012024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6982LEVOTHYROXINE SODIUM TABLET [A-S MEDICATION SOLUTIONS]7Current NDC, 2 package rows20231229_e2291336-1188-48f4-af52-d12ac892f80f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966224levothyroxine sodium 125 MCG Oral TabletPSNe2291336-1188-48f4-af52-d12ac892f80f9
966224levothyroxine sodium 0.125 MG Oral TabletSCDe2291336-1188-48f4-af52-d12ac892f80f9
966224levothyroxine sodium 125 MCG Oral TabletSYe2291336-1188-48f4-af52-d12ac892f80f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6982-05009069820030 TABLET in 1 BOTTLE (50090-6982-0) 30 tablet2023-12-26NoNoHistorical
50090-6982-15009069820190 TABLET in 1 BOTTLE (50090-6982-1) 90 tablet2023-12-26NoNoHistorical