FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
71335-3116
11-digit product format
713353116
Labeler code
71335
Product ID
71335-3116_03c8c731-bb36-40e0-bd9d-8a90c31c3301
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209713
Marketing category
ANDA
Marketing start
2019-03-20
Substance
LEVOTHYROXINE SODIUM
Active strength
.15 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.15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966225

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-3116-1Levothyroxine Sodium30 in 1 BOTTLETABLET301
71335-3116-2Levothyroxine Sodium100 in 1 BOTTLETABLET1001
71335-3116-3Levothyroxine Sodium90 in 1 BOTTLETABLET901
71335-3116-4Levothyroxine Sodium60 in 1 BOTTLETABLET601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966225levothyroxine sodium 150 MCG Oral TabletPSN2ecaa38f-8a6f-4536-8033-251d2c52ae641
966225levothyroxine sodium 0.15 MG Oral TabletSCD2ecaa38f-8a6f-4536-8033-251d2c52ae641
966225levothyroxine sodium 150 MCG Oral TabletSY2ecaa38f-8a6f-4536-8033-251d2c52ae641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3116-17133531160130 TABLET in 1 BOTTLE (71335-3116-1) 30 tablet2026-03-30NoNoHistorical
71335-3116-271335311602100 TABLET in 1 BOTTLE (71335-3116-2) 100 tablet2026-03-30NoNoHistorical
71335-3116-37133531160390 TABLET in 1 BOTTLE (71335-3116-3) 90 tablet2026-03-30NoNoHistorical
71335-3116-47133531160460 TABLET in 1 BOTTLE (71335-3116-4) 60 tablet2026-03-30NoNoHistorical