Levothyroxine Sodium

Product NDC
10544-247
11-digit product format
105440247
Labeler code
10544
Product ID
10544-247_1221a437-07b0-291f-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
NDA021210
Marketing category
NDA
Marketing start
2013-11-15
Marketing end
0000-00-00
Substance
LEVOTHYROXINE SODIUM
Active strength
0 mg/1
Pharmacologic classes
l-Thyroxine [EPC],Thyroxine [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-247-302020-01-31C16284748780-19d75b9d0-8704-f424-e053-dadaa90a57ceLevothyroxine Sodium Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-247-30Levothyroxine Sodium30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-247-30EA - Each10544-24794dc88b1-0a99-4135-b97b-230e4dec405f12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOTHYROXINE SODIUMACTIVE INGREDIENT9J765S329GLEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]4
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]4
ACACIAINACTIVE INGREDIENT5C5403N26OLEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]4
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-247LEVOTHYROXINE SODIUM TABLET [BLENHEIM PHARMACAL, INC.]4Legacy NDC, 1 package rows20150326_0f547137-d471-15f6-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892246levothyroxine sodium 100 MCG Oral TabletPSN0f547137-d471-15f6-e054-00144ff8d46c4
966248levothyroxine sodium 112 MCG Oral TabletPSN0f547137-d471-15f6-e054-00144ff8d46c4
966224levothyroxine sodium 125 MCG Oral TabletPSN0f547137-d471-15f6-e054-00144ff8d46c4
966270levothyroxine sodium 137 MCG Oral TabletPSN0f547137-d471-15f6-e054-00144ff8d46c4
966225levothyroxine sodium 150 MCG Oral TabletPSN0f547137-d471-15f6-e054-00144ff8d46c4
966220levothyroxine sodium 25 MCG Oral TabletPSN0f547137-d471-15f6-e054-00144ff8d46c4
966221levothyroxine sodium 50 MCG Oral TabletPSN0f547137-d471-15f6-e054-00144ff8d46c4
966222levothyroxine sodium 75 MCG Oral TabletPSN0f547137-d471-15f6-e054-00144ff8d46c4
966253levothyroxine sodium 88 MCG Oral TabletPSN0f547137-d471-15f6-e054-00144ff8d46c4
966220levothyroxine sodium 0.025 MG Oral TabletSCD0f547137-d471-15f6-e054-00144ff8d46c4
966221levothyroxine sodium 0.05 MG Oral TabletSCD0f547137-d471-15f6-e054-00144ff8d46c4
966222levothyroxine sodium 0.075 MG Oral TabletSCD0f547137-d471-15f6-e054-00144ff8d46c4
966253levothyroxine sodium 0.088 MG Oral TabletSCD0f547137-d471-15f6-e054-00144ff8d46c4
892246levothyroxine sodium 0.1 MG Oral TabletSCD0f547137-d471-15f6-e054-00144ff8d46c4
966248levothyroxine sodium 0.112 MG Oral TabletSCD0f547137-d471-15f6-e054-00144ff8d46c4
966224levothyroxine sodium 0.125 MG Oral TabletSCD0f547137-d471-15f6-e054-00144ff8d46c4
966270levothyroxine sodium 0.137 MG Oral TabletSCD0f547137-d471-15f6-e054-00144ff8d46c4
966225levothyroxine sodium 0.15 MG Oral TabletSCD0f547137-d471-15f6-e054-00144ff8d46c4
892246levothyroxine sodium 100 MCG Oral TabletSY0f547137-d471-15f6-e054-00144ff8d46c4
966248levothyroxine sodium 112 MCG Oral TabletSY0f547137-d471-15f6-e054-00144ff8d46c4
966224levothyroxine sodium 125 MCG Oral TabletSY0f547137-d471-15f6-e054-00144ff8d46c4
966270levothyroxine sodium 137 MCG Oral TabletSY0f547137-d471-15f6-e054-00144ff8d46c4
966225levothyroxine sodium 150 MCG Oral TabletSY0f547137-d471-15f6-e054-00144ff8d46c4
966220levothyroxine sodium 25 MCG Oral TabletSY0f547137-d471-15f6-e054-00144ff8d46c4
966221levothyroxine sodium 50 MCG Oral TabletSY0f547137-d471-15f6-e054-00144ff8d46c4
966222levothyroxine sodium 75 MCG Oral TabletSY0f547137-d471-15f6-e054-00144ff8d46c4
966253levothyroxine sodium 88 MCG Oral TabletSY0f547137-d471-15f6-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-247-301054402473030 in 1 BOTTLE, PLASTICHistorical