FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
71205-221
11-digit product format
712050221
Labeler code
71205
Product ID
71205-221_aca8c79e-06fa-4919-bc65-a2aff5429fde
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
NDA021210
Marketing category
NDA
Marketing start
2003-12-01
Substance
LEVOTHYROXINE SODIUM
Active strength
.025 mg/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levothyroxine Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM.025 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966220, 966248

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
71205-221-30Levothyroxine Sodium30 in 1 BOTTLE, PLASTICTABLET302
71205-221-60Levothyroxine Sodium60 in 1 BOTTLE, PLASTICTABLET602
71205-221-90Levothyroxine Sodium90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-221-30EA - Each71205-22167e03466-7cf5-47d8-9295-0c366d0cec7512019-08-06
71205-221-90EA - Each71205-22184aaf838-27f0-483e-9133-eccbe314655912019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-221LEVOTHYROXINE SODIUM TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20210112_2f0657d5-3e5c-4249-bfaa-7f5ef1528672.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966248levothyroxine sodium 112 MCG Oral TabletPSN2f0657d5-3e5c-4249-bfaa-7f5ef15286722
966220levothyroxine sodium 25 MCG Oral TabletPSN2f0657d5-3e5c-4249-bfaa-7f5ef15286722
966220levothyroxine sodium 0.025 MG Oral TabletSCD2f0657d5-3e5c-4249-bfaa-7f5ef15286722
966248levothyroxine sodium 0.112 MG Oral TabletSCD2f0657d5-3e5c-4249-bfaa-7f5ef15286722
966248levothyroxine sodium 112 MCG Oral TabletSY2f0657d5-3e5c-4249-bfaa-7f5ef15286722
966220levothyroxine sodium 25 MCG Oral TabletSY2f0657d5-3e5c-4249-bfaa-7f5ef15286722

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-221-307120502213030 TABLET in 1 BOTTLE, PLASTIC (71205-221-30) 30 tablet2003-12-010000-00-00NoNoCurrent
71205-221-607120502216060 TABLET in 1 BOTTLE, PLASTIC (71205-221-60) 60 tablet2003-12-010000-00-00NoNoCurrent
71205-221-907120502219090 TABLET in 1 BOTTLE, PLASTIC (71205-221-90) 90 tablet2019-02-010000-00-00NoNoCurrent