FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
82347-0010
11-digit product format
823470010
Labeler code
82347
Product ID
82347-0010_4dde84bb-3bd3-6722-e063-6394a90a4c09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
YARAL Pharma Inc.
Application
NDA021924
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2023-03-01
Substance
LEVOTHYROXINE SODIUM
Active strength
25 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 SODIUM25 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui905451, 905455, 905458, 905462, 966404, 966405, 966406, 966407, 966412, 966413, 1923047, 1923050

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
82347-0010-4Levothyroxine Sodium3 in 1 CARTONCAPSULE37
82347-0010-4Levothyroxine Sodium10 in 1 BLISTER PACKCAPSULE107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82347-0010-4EA - Each82347-0010534ec198-dcb4-494d-88c7-0888232eb7c612023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82347-0010LEVOTHYROXINE SODIUM CAPSULE [YARAL PHARMA INC.]5Current NDC, Legacy NDC, 2 package rows20231128_d28d7202-1278-0486-e053-2995a90af286.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966404levothyroxine sodium 100 MCG Oral CapsulePSNd28d7202-1278-0486-e053-2995a90af2867
905451levothyroxine sodium 112 MCG Oral CapsulePSNd28d7202-1278-0486-e053-2995a90af2867
966405levothyroxine sodium 125 MCG Oral CapsulePSNd28d7202-1278-0486-e053-2995a90af2867
966412levothyroxine sodium 13 MCG Oral CapsulePSNd28d7202-1278-0486-e053-2995a90af2867
905455levothyroxine sodium 137 MCG Oral CapsulePSNd28d7202-1278-0486-e053-2995a90af2867
966413levothyroxine sodium 150 MCG Oral CapsulePSNd28d7202-1278-0486-e053-2995a90af2867
1923047levothyroxine sodium 175 MCG Oral CapsulePSNd28d7202-1278-0486-e053-2995a90af2867
1923050levothyroxine sodium 200 MCG Oral CapsulePSNd28d7202-1278-0486-e053-2995a90af2867
966406levothyroxine sodium 25 MCG Oral CapsulePSNd28d7202-1278-0486-e053-2995a90af2867
966407levothyroxine sodium 50 MCG Oral CapsulePSNd28d7202-1278-0486-e053-2995a90af2867
905458levothyroxine sodium 75 MCG Oral CapsulePSNd28d7202-1278-0486-e053-2995a90af2867
905462levothyroxine sodium 88 MCG Oral CapsulePSNd28d7202-1278-0486-e053-2995a90af2867
966412levothyroxine sodium 0.013 MG Oral CapsuleSCDd28d7202-1278-0486-e053-2995a90af2867
966406levothyroxine sodium 0.025 MG Oral CapsuleSCDd28d7202-1278-0486-e053-2995a90af2867
966407levothyroxine sodium 0.05 MG Oral CapsuleSCDd28d7202-1278-0486-e053-2995a90af2867
905458levothyroxine sodium 0.075 MG Oral CapsuleSCDd28d7202-1278-0486-e053-2995a90af2867
905462levothyroxine sodium 0.088 MG Oral CapsuleSCDd28d7202-1278-0486-e053-2995a90af2867
966404levothyroxine sodium 0.1 MG Oral CapsuleSCDd28d7202-1278-0486-e053-2995a90af2867
905451levothyroxine sodium 0.112 MG Oral CapsuleSCDd28d7202-1278-0486-e053-2995a90af2867
966405levothyroxine sodium 0.125 MG Oral CapsuleSCDd28d7202-1278-0486-e053-2995a90af2867
905455levothyroxine sodium 0.137 MG Oral CapsuleSCDd28d7202-1278-0486-e053-2995a90af2867
966413levothyroxine sodium 0.15 MG Oral CapsuleSCDd28d7202-1278-0486-e053-2995a90af2867
1923047levothyroxine sodium 0.175 MG Oral CapsuleSCDd28d7202-1278-0486-e053-2995a90af2867
1923050levothyroxine sodium 0.2 MG Oral CapsuleSCDd28d7202-1278-0486-e053-2995a90af2867
966404levothyroxine sodium 100 MCG Oral CapsuleSYd28d7202-1278-0486-e053-2995a90af2867
905451levothyroxine sodium 112 MCG Oral CapsuleSYd28d7202-1278-0486-e053-2995a90af2867
966405levothyroxine sodium 125 MCG Oral CapsuleSYd28d7202-1278-0486-e053-2995a90af2867
966412levothyroxine sodium 13 MCG Oral CapsuleSYd28d7202-1278-0486-e053-2995a90af2867
905455levothyroxine sodium 137 MCG Oral CapsuleSYd28d7202-1278-0486-e053-2995a90af2867
966413levothyroxine sodium 150 MCG Oral CapsuleSYd28d7202-1278-0486-e053-2995a90af2867
1923047levothyroxine sodium 175 MCG Oral CapsuleSYd28d7202-1278-0486-e053-2995a90af2867
1923050levothyroxine sodium 200 MCG Oral CapsuleSYd28d7202-1278-0486-e053-2995a90af2867
966406levothyroxine sodium 25 MCG Oral CapsuleSYd28d7202-1278-0486-e053-2995a90af2867
966407levothyroxine sodium 50 MCG Oral CapsuleSYd28d7202-1278-0486-e053-2995a90af2867
905458levothyroxine sodium 75 MCG Oral CapsuleSYd28d7202-1278-0486-e053-2995a90af2867
905462levothyroxine sodium 88 MCG Oral CapsuleSYd28d7202-1278-0486-e053-2995a90af2867

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82347-0010-4823470010043 BLISTER PACK in 1 CARTON (82347-0010-4) / 10 CAPSULE in 1 BLISTER PACK3 blister pack2023-03-010000-00-00NoNoCurrent