FDA.reportPublic FDA data

LEVOTHYROXINE SODIUM

Product NDC
31722-288
11-digit product format
317220288
Labeler code
31722
Product ID
31722-288_7c79df0b-836b-479b-a7a6-8e09b802a84e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA215259
Marketing category
ANDA
Marketing start
2023-01-18
Substance
LEVOTHYROXINE SODIUM
Active strength
.1 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.1 mg/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
31722-288-01LEVOTHYROXINE SODIUM100 in 1 BOTTLETABLET1001
31722-288-10LEVOTHYROXINE SODIUM1000 in 1 BOTTLETABLET10001
31722-288-30LEVOTHYROXINE SODIUM30 in 1 BOTTLETABLET301
31722-288-90LEVOTHYROXINE SODIUM90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-288-10EA - Each31722-288a04c7ec5-5262-4d84-8586-27290f7a4af212023-04-07
31722-288-90EA - Each31722-2882a5e7adf-96fb-4788-b0fe-8815737f46e412023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-288LEVOTHYROXINE SODIUM TABLET [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 4 package rows20230124_b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892246levothyroxine sodium 100 MCG Oral TabletPSNb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966248levothyroxine sodium 112 MCG Oral TabletPSNb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966224levothyroxine sodium 125 MCG Oral TabletPSNb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966270levothyroxine sodium 137 MCG Oral TabletPSNb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966225levothyroxine sodium 150 MCG Oral TabletPSNb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966249levothyroxine sodium 175 MCG Oral TabletPSNb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
892251levothyroxine sodium 200 MCG Oral TabletPSNb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966220levothyroxine sodium 25 MCG Oral TabletPSNb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
892255levothyroxine sodium 300 MCG Oral TabletPSNb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966221levothyroxine sodium 50 MCG Oral TabletPSNb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966222levothyroxine sodium 75 MCG Oral TabletPSNb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966253levothyroxine sodium 88 MCG Oral TabletPSNb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966220levothyroxine sodium 0.025 MG Oral TabletSCDb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966221levothyroxine sodium 0.05 MG Oral TabletSCDb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966222levothyroxine sodium 0.075 MG Oral TabletSCDb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966253levothyroxine sodium 0.088 MG Oral TabletSCDb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
892246levothyroxine sodium 0.1 MG Oral TabletSCDb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966248levothyroxine sodium 0.112 MG Oral TabletSCDb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966224levothyroxine sodium 0.125 MG Oral TabletSCDb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966270levothyroxine sodium 0.137 MG Oral TabletSCDb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966225levothyroxine sodium 0.15 MG Oral TabletSCDb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966249levothyroxine sodium 0.175 MG Oral TabletSCDb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
892251levothyroxine sodium 0.2 MG Oral TabletSCDb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
892255levothyroxine sodium 0.3 MG Oral TabletSCDb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
892246levothyroxine sodium 100 MCG Oral TabletSYb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966248levothyroxine sodium 112 MCG Oral TabletSYb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966224levothyroxine sodium 125 MCG Oral TabletSYb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966270levothyroxine sodium 137 MCG Oral TabletSYb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966225levothyroxine sodium 150 MCG Oral TabletSYb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966249levothyroxine sodium 175 MCG Oral TabletSYb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
892251levothyroxine sodium 200 MCG Oral TabletSYb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966220levothyroxine sodium 25 MCG Oral TabletSYb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
892255levothyroxine sodium 300 MCG Oral TabletSYb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966221levothyroxine sodium 50 MCG Oral TabletSYb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966222levothyroxine sodium 75 MCG Oral TabletSYb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1
966253levothyroxine sodium 88 MCG Oral TabletSYb1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-288-0131722028801100 TABLET in 1 BOTTLE (31722-288-01) 100 tablet2023-01-18NoNoCurrent
31722-288-10317220288101000 TABLET in 1 BOTTLE (31722-288-10) 1000 tablet2023-01-18NoNoCurrent
31722-288-303172202883030 TABLET in 1 BOTTLE (31722-288-30) 30 tablet2023-01-18NoNoCurrent
31722-288-903172202889090 TABLET in 1 BOTTLE (31722-288-90) 90 tablet2023-01-18NoNoCurrent