Levothyroxine sodium

Product NDC
72789-297
11-digit product format
727890297
Labeler code
72789
Product ID
72789-297_4bae1773-79fb-e98a-e063-6394a90a3266
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA212399
Marketing category
ANDA
Marketing start
2020-12-10
Substance
LEVOTHYROXINE SODIUM
Active strength
100 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 SODIUM100 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui892246

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
72789-297-30Levothyroxine sodium30 in 1 BOTTLE, PLASTICTABLET3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-297-30EA - Each72789-297a38da136-17eb-4375-8b2a-2e1bbeafd9ef12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-297LEVOTHYROXINE SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 1 package rows20250221_6f4998ac-0714-4f5d-8944-9e6902b9f0a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892246levothyroxine sodium 100 MCG Oral TabletPSN6f4998ac-0714-4f5d-8944-9e6902b9f0a614
892246levothyroxine sodium 0.1 MG Oral TabletSCD6f4998ac-0714-4f5d-8944-9e6902b9f0a614
892246levothyroxine sodium 100 MCG Oral TabletSY6f4998ac-0714-4f5d-8944-9e6902b9f0a614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-297-307278902973030 TABLET in 1 BOTTLE, PLASTIC (72789-297-30) 30 tablet2023-01-110000-00-00NoNoCurrent