Levothyroxine sodium

Product NDC
68788-7911
11-digit product format
687887911
Labeler code
68788
Product ID
68788-7911_ef2595cf-50d8-499a-aa16-7e7e19b56ce1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA212399
Marketing category
ANDA
Marketing start
2021-05-18
Substance
LEVOTHYROXINE SODIUM
Active strength
50 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 SODIUM50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966221

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
68788-7911-3Levothyroxine sodium30 in 1 BOTTLETABLET306
68788-7911-9Levothyroxine sodium90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7911-3EA - Each68788-7911b26e152c-53bc-4bcf-8419-e5fd5758672012021-07-15
68788-7911-9EA - Each68788-791148834fbf-bc84-4496-b159-a390e02ac4f212021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7911LEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20240614_0cffbc96-7a02-4538-9966-b69249be6eb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966221levothyroxine sodium 50 MCG Oral TabletPSN0cffbc96-7a02-4538-9966-b69249be6eb26
966221levothyroxine sodium 0.05 MG Oral TabletSCD0cffbc96-7a02-4538-9966-b69249be6eb26
966221levothyroxine sodium 50 MCG Oral TabletSY0cffbc96-7a02-4538-9966-b69249be6eb26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7911-36878879110330 TABLET in 1 BOTTLE (68788-7911-3) 30 tablet2021-05-180000-00-00NoNoCurrent
68788-7911-96878879110990 TABLET in 1 BOTTLE (68788-7911-9) 90 tablet2021-05-180000-00-00NoNoCurrent