FDA.reportPublic FDA data

Levothyroxine sodium

Product NDC
71335-1827
11-digit product format
713351827
Labeler code
71335
Product ID
71335-1827_99522782-da02-4402-b98a-40b831694bf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212399
Marketing category
ANDA
Marketing start
2020-11-25
Substance
LEVOTHYROXINE SODIUM
Active strength
75 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 SODIUM75 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966222

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
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
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1827-1Levothyroxine sodium30 in 1 BOTTLETABLET30106
71335-1827-2Levothyroxine sodium100 in 1 BOTTLETABLET100106
71335-1827-3Levothyroxine sodium60 in 1 BOTTLETABLET60106
71335-1827-4Levothyroxine sodium90 in 1 BOTTLETABLET90106
71335-1827-5Levothyroxine sodium28 in 1 BOTTLETABLET28106
71335-1827-6Levothyroxine sodium10 in 1 BOTTLETABLET10106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1827-1EA - Each71335-1827779979a0-18e5-4d55-89d3-a18327ff394412026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1827LEVOTHYROXINE SODIUM TABLET [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 6 package rows20241225_775ef7ba-0b5b-40ba-ac7b-2aef121fe4f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966222levothyroxine sodium 75 MCG Oral TabletPSN775ef7ba-0b5b-40ba-ac7b-2aef121fe4f4106
966222levothyroxine sodium 0.075 MG Oral TabletSCD775ef7ba-0b5b-40ba-ac7b-2aef121fe4f4106
966222levothyroxine sodium 75 MCG Oral TabletSY775ef7ba-0b5b-40ba-ac7b-2aef121fe4f4106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1827-17133518270130 TABLET in 1 BOTTLE (71335-1827-1) 30 tablet2021-06-140000-00-00NoNoCurrent
71335-1827-271335182702100 TABLET in 1 BOTTLE (71335-1827-2) 100 tablet2022-03-140000-00-00NoNoCurrent
71335-1827-37133518270360 TABLET in 1 BOTTLE (71335-1827-3) 60 tablet2024-12-110000-00-00NoNoCurrent
71335-1827-47133518270490 TABLET in 1 BOTTLE (71335-1827-4) 90 tablet2021-04-090000-00-00NoNoCurrent
71335-1827-57133518270528 TABLET in 1 BOTTLE (71335-1827-5) 28 tablet2024-12-110000-00-00NoNoCurrent
71335-1827-67133518270610 TABLET in 1 BOTTLE (71335-1827-6) 10 tablet2024-12-11NoNoHistorical