FDA.reportPublic FDA data

Levothyroxine sodium

Product NDC
0480-8693
11-digit product format
004808693
Labeler code
0480
Product ID
0480-8693_8f65417f-488f-4e4a-894c-56f99ed57d25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA207588
Marketing category
ANDA
Marketing start
2022-09-21
Marketing end
2026-11-30
Substance
LEVOTHYROXINE SODIUM
Active strength
88 ug/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levothyroxine sodium

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM88 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui892246, 892251, 892255, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 966253, 966270

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
0480-8693-01Levothyroxine sodium100 in 1 BOTTLETABLET1008
0480-8693-10Levothyroxine sodium1000 in 1 BOTTLETABLET10008
0480-8693-98Levothyroxine sodium90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-8693-01EA - Each0480-8693bac787f7-fc52-4211-9aae-83f126fce84f12022-10-06
0480-8693-10EA - Each0480-86939bfb01b2-081e-43fe-a72f-8667d97e0ed812022-10-06
0480-8693-98EA - Each0480-8693b64e30f2-e0df-40d3-ab69-3fc57737675b12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-8693LEVOTHYROXINE SODIUM TABLET [TEVA PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 3 package rows20240702_60cadfd7-82b5-4207-97e1-1dd0655efb27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892246levothyroxine sodium 100 MCG Oral TabletPSN60cadfd7-82b5-4207-97e1-1dd0655efb278
966248levothyroxine sodium 112 MCG Oral TabletPSN60cadfd7-82b5-4207-97e1-1dd0655efb278
966224levothyroxine sodium 125 MCG Oral TabletPSN60cadfd7-82b5-4207-97e1-1dd0655efb278
966270levothyroxine sodium 137 MCG Oral TabletPSN60cadfd7-82b5-4207-97e1-1dd0655efb278
966225levothyroxine sodium 150 MCG Oral TabletPSN60cadfd7-82b5-4207-97e1-1dd0655efb278
966249levothyroxine sodium 175 MCG Oral TabletPSN60cadfd7-82b5-4207-97e1-1dd0655efb278
892251levothyroxine sodium 200 MCG Oral TabletPSN60cadfd7-82b5-4207-97e1-1dd0655efb278
966220levothyroxine sodium 25 MCG Oral TabletPSN60cadfd7-82b5-4207-97e1-1dd0655efb278
892255levothyroxine sodium 300 MCG Oral TabletPSN60cadfd7-82b5-4207-97e1-1dd0655efb278
966221levothyroxine sodium 50 MCG Oral TabletPSN60cadfd7-82b5-4207-97e1-1dd0655efb278
966222levothyroxine sodium 75 MCG Oral TabletPSN60cadfd7-82b5-4207-97e1-1dd0655efb278
966253levothyroxine sodium 88 MCG Oral TabletPSN60cadfd7-82b5-4207-97e1-1dd0655efb278
966220levothyroxine sodium 0.025 MG Oral TabletSCD60cadfd7-82b5-4207-97e1-1dd0655efb278
966221levothyroxine sodium 0.05 MG Oral TabletSCD60cadfd7-82b5-4207-97e1-1dd0655efb278
966222levothyroxine sodium 0.075 MG Oral TabletSCD60cadfd7-82b5-4207-97e1-1dd0655efb278
966253levothyroxine sodium 0.088 MG Oral TabletSCD60cadfd7-82b5-4207-97e1-1dd0655efb278
892246levothyroxine sodium 0.1 MG Oral TabletSCD60cadfd7-82b5-4207-97e1-1dd0655efb278
966248levothyroxine sodium 0.112 MG Oral TabletSCD60cadfd7-82b5-4207-97e1-1dd0655efb278
966224levothyroxine sodium 0.125 MG Oral TabletSCD60cadfd7-82b5-4207-97e1-1dd0655efb278
966270levothyroxine sodium 0.137 MG Oral TabletSCD60cadfd7-82b5-4207-97e1-1dd0655efb278
966225levothyroxine sodium 0.15 MG Oral TabletSCD60cadfd7-82b5-4207-97e1-1dd0655efb278
966249levothyroxine sodium 0.175 MG Oral TabletSCD60cadfd7-82b5-4207-97e1-1dd0655efb278
892251levothyroxine sodium 0.2 MG Oral TabletSCD60cadfd7-82b5-4207-97e1-1dd0655efb278
892255levothyroxine sodium 0.3 MG Oral TabletSCD60cadfd7-82b5-4207-97e1-1dd0655efb278
892246levothyroxine sodium 100 MCG Oral TabletSY60cadfd7-82b5-4207-97e1-1dd0655efb278
966248levothyroxine sodium 112 MCG Oral TabletSY60cadfd7-82b5-4207-97e1-1dd0655efb278
966224levothyroxine sodium 125 MCG Oral TabletSY60cadfd7-82b5-4207-97e1-1dd0655efb278
966270levothyroxine sodium 137 MCG Oral TabletSY60cadfd7-82b5-4207-97e1-1dd0655efb278
966225levothyroxine sodium 150 MCG Oral TabletSY60cadfd7-82b5-4207-97e1-1dd0655efb278
966249levothyroxine sodium 175 MCG Oral TabletSY60cadfd7-82b5-4207-97e1-1dd0655efb278
892251levothyroxine sodium 200 MCG Oral TabletSY60cadfd7-82b5-4207-97e1-1dd0655efb278
966220levothyroxine sodium 25 MCG Oral TabletSY60cadfd7-82b5-4207-97e1-1dd0655efb278
892255levothyroxine sodium 300 MCG Oral TabletSY60cadfd7-82b5-4207-97e1-1dd0655efb278
966221levothyroxine sodium 50 MCG Oral TabletSY60cadfd7-82b5-4207-97e1-1dd0655efb278
966222levothyroxine sodium 75 MCG Oral TabletSY60cadfd7-82b5-4207-97e1-1dd0655efb278
966253levothyroxine sodium 88 MCG Oral TabletSY60cadfd7-82b5-4207-97e1-1dd0655efb278
966253levothyroxine sodium 88 MCG Oral TabletPSNa55e735f-a5b0-4b85-9fd7-3a4b6723a81b1
966253levothyroxine sodium 88 MCG Oral TabletPSNe1f77539-2156-4890-baca-8b13779c745c1
966253levothyroxine sodium 0.088 MG Oral TabletSCDa55e735f-a5b0-4b85-9fd7-3a4b6723a81b1
966253levothyroxine sodium 0.088 MG Oral TabletSCDe1f77539-2156-4890-baca-8b13779c745c1
966253levothyroxine sodium 88 MCG Oral TabletSYa55e735f-a5b0-4b85-9fd7-3a4b6723a81b1
966253levothyroxine sodium 88 MCG Oral TabletSYe1f77539-2156-4890-baca-8b13779c745c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0480-8693-0100480869301100 TABLET in 1 BOTTLE (0480-8693-01) 100 tablet2022-06-240000-00-00NoNoCurrent
0480-8693-10004808693101000 TABLET in 1 BOTTLE (0480-8693-10) 1000 tablet2022-09-212026-11-30NoNoCurrent
0480-8693-980048086939890 TABLET in 1 BOTTLE (0480-8693-98) 90 tablet2022-09-212026-11-30NoNoCurrent