FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
0904-6957
11-digit product format
009046957
Labeler code
0904
Product ID
0904-6957_942c00a3-b31c-48d5-a63d-6d394645ee1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA209713
Marketing category
ANDA
Marketing start
2019-03-20
Substance
LEVOTHYROXINE SODIUM
Active strength
.175 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.175 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui892246, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 966253

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
97c252d3-9bb8-4530-bb44-9824dc7cf556Product name620250729
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
6c43b71c-35e6-4db3-ba24-c6ef42ff7003Product name320240207
890fd4bf-1a80-42b7-be1b-2d0259d5f0c8Product name520240207
c8ad26bf-af73-460b-b74e-1eff16cc4f9fProduct name520240207
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
01383843-4069-43cf-aa76-dc17a6f9f8c4Product name220230123
978cca7d-a938-4791-8322-da48d90a63efProduct name120230113
65f86ba3-8816-4e12-899b-18290c8de551Product name220210614
f16ab90f-08c2-40be-a543-66d9827cd1f3Product name120210601
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
6a33ec05-2ae2-45e5-ab82-2d94b3303923Product name120190709
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
93355a10-1c44-4c92-a11d-7d995e0200d9Product name120190219
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6957-61Levothyroxine Sodium1 in 1 BLISTER PACKTABLET18
0904-6957-61Levothyroxine Sodium100 in 1 CARTONTABLET1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6957LEVOTHYROXINE SODIUM TABLET [MAJOR PHARMACEUTICALS]7Current NDC, Legacy NDC, 2 package rows20241128_333642fd-93ae-4dc0-9c83-6d6b163c1c74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892246levothyroxine sodium 100 MCG Oral TabletPSN333642fd-93ae-4dc0-9c83-6d6b163c1c748
966248levothyroxine sodium 112 MCG Oral TabletPSN333642fd-93ae-4dc0-9c83-6d6b163c1c748
966224levothyroxine sodium 125 MCG Oral TabletPSN333642fd-93ae-4dc0-9c83-6d6b163c1c748
966225levothyroxine sodium 150 MCG Oral TabletPSN333642fd-93ae-4dc0-9c83-6d6b163c1c748
966249levothyroxine sodium 175 MCG Oral TabletPSN333642fd-93ae-4dc0-9c83-6d6b163c1c748
966220levothyroxine sodium 25 MCG Oral TabletPSN333642fd-93ae-4dc0-9c83-6d6b163c1c748
966221levothyroxine sodium 50 MCG Oral TabletPSN333642fd-93ae-4dc0-9c83-6d6b163c1c748
966222levothyroxine sodium 75 MCG Oral TabletPSN333642fd-93ae-4dc0-9c83-6d6b163c1c748
966253levothyroxine sodium 88 MCG Oral TabletPSN333642fd-93ae-4dc0-9c83-6d6b163c1c748
966220levothyroxine sodium 0.025 MG Oral TabletSCD333642fd-93ae-4dc0-9c83-6d6b163c1c748
966221levothyroxine sodium 0.05 MG Oral TabletSCD333642fd-93ae-4dc0-9c83-6d6b163c1c748
966222levothyroxine sodium 0.075 MG Oral TabletSCD333642fd-93ae-4dc0-9c83-6d6b163c1c748
966253levothyroxine sodium 0.088 MG Oral TabletSCD333642fd-93ae-4dc0-9c83-6d6b163c1c748
892246levothyroxine sodium 0.1 MG Oral TabletSCD333642fd-93ae-4dc0-9c83-6d6b163c1c748
966248levothyroxine sodium 0.112 MG Oral TabletSCD333642fd-93ae-4dc0-9c83-6d6b163c1c748
966224levothyroxine sodium 0.125 MG Oral TabletSCD333642fd-93ae-4dc0-9c83-6d6b163c1c748
966225levothyroxine sodium 0.15 MG Oral TabletSCD333642fd-93ae-4dc0-9c83-6d6b163c1c748
966249levothyroxine sodium 0.175 MG Oral TabletSCD333642fd-93ae-4dc0-9c83-6d6b163c1c748
892246levothyroxine sodium 100 MCG Oral TabletSY333642fd-93ae-4dc0-9c83-6d6b163c1c748
966248levothyroxine sodium 112 MCG Oral TabletSY333642fd-93ae-4dc0-9c83-6d6b163c1c748
966224levothyroxine sodium 125 MCG Oral TabletSY333642fd-93ae-4dc0-9c83-6d6b163c1c748
966225levothyroxine sodium 150 MCG Oral TabletSY333642fd-93ae-4dc0-9c83-6d6b163c1c748
966249levothyroxine sodium 175 MCG Oral TabletSY333642fd-93ae-4dc0-9c83-6d6b163c1c748
966220levothyroxine sodium 25 MCG Oral TabletSY333642fd-93ae-4dc0-9c83-6d6b163c1c748
966221levothyroxine sodium 50 MCG Oral TabletSY333642fd-93ae-4dc0-9c83-6d6b163c1c748
966222levothyroxine sodium 75 MCG Oral TabletSY333642fd-93ae-4dc0-9c83-6d6b163c1c748
966253levothyroxine sodium 88 MCG Oral TabletSY333642fd-93ae-4dc0-9c83-6d6b163c1c748

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6957-6100904695761100 BLISTER PACK in 1 CARTON (0904-6957-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2019-03-200000-00-00NoNoCurrent