levothyroxine sodium

Product NDC
68788-7697
11-digit product format
687887697
Labeler code
68788
Product ID
68788-7697_21fcb98b-6940-4d93-86df-66ccd02b9c34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
NDA021116
Marketing category
NDA
Marketing start
2020-04-01
Substance
LEVOTHYROXINE SODIUM
Active strength
112 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 SODIUM112 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966248

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
68788-7697-1levothyroxine sodium100 in 1 BOTTLETABLET1007
68788-7697-3levothyroxine sodium30 in 1 BOTTLETABLET307
68788-7697-9levothyroxine sodium90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7697-1EA - Each68788-7697383e850c-126a-4f04-ad7a-02719c8103bb12020-07-13
68788-7697-3EA - Each68788-7697c0409d97-4592-4717-bced-0111d6a9712112020-07-13
68788-7697-9EA - Each68788-76974c188ae3-d15c-4d74-9d33-d7e8437a000712020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7697LEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 3 package rows20240415_579b1935-77f5-4381-9cb0-e0130e4834e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966248levothyroxine sodium 112 MCG Oral TabletPSN579b1935-77f5-4381-9cb0-e0130e4834e87
966248levothyroxine sodium 0.112 MG Oral TabletSCD579b1935-77f5-4381-9cb0-e0130e4834e87
966248levothyroxine sodium 112 MCG Oral TabletSY579b1935-77f5-4381-9cb0-e0130e4834e87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7697-168788769701100 TABLET in 1 BOTTLE (68788-7697-1) 100 tablet2020-04-010000-00-00NoNoCurrent
68788-7697-36878876970330 TABLET in 1 BOTTLE (68788-7697-3) 30 tablet2020-04-010000-00-00NoNoCurrent
68788-7697-96878876970990 TABLET in 1 BOTTLE (68788-7697-9) 90 tablet2020-04-010000-00-00NoNoCurrent