FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
69238-1838
11-digit product format
692381838
Labeler code
69238
Product ID
69238-1838_3a92e520-3da8-43be-9be2-63511c44b735
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
NDA021210
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2003-12-01
Substance
LEVOTHYROXINE SODIUM
Active strength
.15 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.15 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69238-1838-12024-02-08C16284748780-11030e365-3633-111a-e063-dadaa90a10e2Levothyroxine Sodium Tablets, USP
69238-1838-72024-02-08C16284748780-11030e365-3633-111a-e063-dadaa90a10e2Levothyroxine Sodium Tablets, USP
69238-1838-12024-01-30C16284748780-11030e365-3633-111a-e063-dadaa90a10e2Levothyroxine Sodium Tablets, USP
69238-1838-72024-01-30C16284748780-11030e365-3633-111a-e063-dadaa90a10e2Levothyroxine Sodium Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1838-1Levothyroxine Sodium100 in 1 BOTTLE, PLASTICTABLET10010
69238-1838-7Levothyroxine Sodium1000 in 1 BOTTLE, PLASTICTABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1838-1EA - Each69238-1838cf319c46-911e-4d4d-b026-f77a1993465012018-12-13
69238-1838-7EA - Each69238-18387a87f520-ca39-41a3-bb47-059b15a9f04f12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1838LEVOTHYROXINE SODIUM TABLET [AMNEAL PHARMACEUTICALS NY LLC]10Current NDC, Legacy NDC, 2 package rows20241208_fca88c97-5cd4-4834-ba87-deb5bd637788.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892246levothyroxine sodium 100 MCG Oral TabletPSNfca88c97-5cd4-4834-ba87-deb5bd63778810
966248levothyroxine sodium 112 MCG Oral TabletPSNfca88c97-5cd4-4834-ba87-deb5bd63778810
966224levothyroxine sodium 125 MCG Oral TabletPSNfca88c97-5cd4-4834-ba87-deb5bd63778810
966270levothyroxine sodium 137 MCG Oral TabletPSNfca88c97-5cd4-4834-ba87-deb5bd63778810
966225levothyroxine sodium 150 MCG Oral TabletPSNfca88c97-5cd4-4834-ba87-deb5bd63778810
966249levothyroxine sodium 175 MCG Oral TabletPSNfca88c97-5cd4-4834-ba87-deb5bd63778810
892251levothyroxine sodium 200 MCG Oral TabletPSNfca88c97-5cd4-4834-ba87-deb5bd63778810
966220levothyroxine sodium 25 MCG Oral TabletPSNfca88c97-5cd4-4834-ba87-deb5bd63778810
892255levothyroxine sodium 300 MCG Oral TabletPSNfca88c97-5cd4-4834-ba87-deb5bd63778810
966221levothyroxine sodium 50 MCG Oral TabletPSNfca88c97-5cd4-4834-ba87-deb5bd63778810
966222levothyroxine sodium 75 MCG Oral TabletPSNfca88c97-5cd4-4834-ba87-deb5bd63778810
966253levothyroxine sodium 88 MCG Oral TabletPSNfca88c97-5cd4-4834-ba87-deb5bd63778810
966220levothyroxine sodium 0.025 MG Oral TabletSCDfca88c97-5cd4-4834-ba87-deb5bd63778810
966221levothyroxine sodium 0.05 MG Oral TabletSCDfca88c97-5cd4-4834-ba87-deb5bd63778810
966222levothyroxine sodium 0.075 MG Oral TabletSCDfca88c97-5cd4-4834-ba87-deb5bd63778810
966253levothyroxine sodium 0.088 MG Oral TabletSCDfca88c97-5cd4-4834-ba87-deb5bd63778810
892246levothyroxine sodium 0.1 MG Oral TabletSCDfca88c97-5cd4-4834-ba87-deb5bd63778810
966248levothyroxine sodium 0.112 MG Oral TabletSCDfca88c97-5cd4-4834-ba87-deb5bd63778810
966224levothyroxine sodium 0.125 MG Oral TabletSCDfca88c97-5cd4-4834-ba87-deb5bd63778810
966270levothyroxine sodium 0.137 MG Oral TabletSCDfca88c97-5cd4-4834-ba87-deb5bd63778810
966225levothyroxine sodium 0.15 MG Oral TabletSCDfca88c97-5cd4-4834-ba87-deb5bd63778810
966249levothyroxine sodium 0.175 MG Oral TabletSCDfca88c97-5cd4-4834-ba87-deb5bd63778810
892251levothyroxine sodium 0.2 MG Oral TabletSCDfca88c97-5cd4-4834-ba87-deb5bd63778810
892255levothyroxine sodium 0.3 MG Oral TabletSCDfca88c97-5cd4-4834-ba87-deb5bd63778810
892246levothyroxine sodium 100 MCG Oral TabletSYfca88c97-5cd4-4834-ba87-deb5bd63778810
966248levothyroxine sodium 112 MCG Oral TabletSYfca88c97-5cd4-4834-ba87-deb5bd63778810
966224levothyroxine sodium 125 MCG Oral TabletSYfca88c97-5cd4-4834-ba87-deb5bd63778810
966270levothyroxine sodium 137 MCG Oral TabletSYfca88c97-5cd4-4834-ba87-deb5bd63778810
966225levothyroxine sodium 150 MCG Oral TabletSYfca88c97-5cd4-4834-ba87-deb5bd63778810
966249levothyroxine sodium 175 MCG Oral TabletSYfca88c97-5cd4-4834-ba87-deb5bd63778810
892251levothyroxine sodium 200 MCG Oral TabletSYfca88c97-5cd4-4834-ba87-deb5bd63778810
966220levothyroxine sodium 25 MCG Oral TabletSYfca88c97-5cd4-4834-ba87-deb5bd63778810
892255levothyroxine sodium 300 MCG Oral TabletSYfca88c97-5cd4-4834-ba87-deb5bd63778810
966221levothyroxine sodium 50 MCG Oral TabletSYfca88c97-5cd4-4834-ba87-deb5bd63778810
966222levothyroxine sodium 75 MCG Oral TabletSYfca88c97-5cd4-4834-ba87-deb5bd63778810
966253levothyroxine sodium 88 MCG Oral TabletSYfca88c97-5cd4-4834-ba87-deb5bd63778810
966248levothyroxine sodium 112 MCG Oral TabletPSNc968836a-f94c-4d13-e053-2995a90a8df54
966224levothyroxine sodium 125 MCG Oral TabletPSNc968836a-f94c-4d13-e053-2995a90a8df54
966270levothyroxine sodium 137 MCG Oral TabletPSNc968836a-f94c-4d13-e053-2995a90a8df54
966225levothyroxine sodium 150 MCG Oral TabletPSNc968836a-f94c-4d13-e053-2995a90a8df54
966225levothyroxine sodium 150 MCG Oral TabletPSNcafb567f-fe8b-4c84-ab0f-ece945fa83c24
966221levothyroxine sodium 50 MCG Oral TabletPSNc968836a-f94c-4d13-e053-2995a90a8df54
966222levothyroxine sodium 75 MCG Oral TabletPSNc968836a-f94c-4d13-e053-2995a90a8df54
966253levothyroxine sodium 88 MCG Oral TabletPSNc968836a-f94c-4d13-e053-2995a90a8df54
966221levothyroxine sodium 0.05 MG Oral TabletSCDc968836a-f94c-4d13-e053-2995a90a8df54
966222levothyroxine sodium 0.075 MG Oral TabletSCDc968836a-f94c-4d13-e053-2995a90a8df54
966253levothyroxine sodium 0.088 MG Oral TabletSCDc968836a-f94c-4d13-e053-2995a90a8df54
966248levothyroxine sodium 0.112 MG Oral TabletSCDc968836a-f94c-4d13-e053-2995a90a8df54
966224levothyroxine sodium 0.125 MG Oral TabletSCDc968836a-f94c-4d13-e053-2995a90a8df54
966270levothyroxine sodium 0.137 MG Oral TabletSCDc968836a-f94c-4d13-e053-2995a90a8df54
966225levothyroxine sodium 0.15 MG Oral TabletSCDcafb567f-fe8b-4c84-ab0f-ece945fa83c24
966225levothyroxine sodium 0.15 MG Oral TabletSCDc968836a-f94c-4d13-e053-2995a90a8df54
966248levothyroxine sodium 112 MCG Oral TabletSYc968836a-f94c-4d13-e053-2995a90a8df54
966224levothyroxine sodium 125 MCG Oral TabletSYc968836a-f94c-4d13-e053-2995a90a8df54
966270levothyroxine sodium 137 MCG Oral TabletSYc968836a-f94c-4d13-e053-2995a90a8df54
966225levothyroxine sodium 150 MCG Oral TabletSYcafb567f-fe8b-4c84-ab0f-ece945fa83c24
966225levothyroxine sodium 150 MCG Oral TabletSYc968836a-f94c-4d13-e053-2995a90a8df54
966221levothyroxine sodium 50 MCG Oral TabletSYc968836a-f94c-4d13-e053-2995a90a8df54
966222levothyroxine sodium 75 MCG Oral TabletSYc968836a-f94c-4d13-e053-2995a90a8df54
966253levothyroxine sodium 88 MCG Oral TabletSYc968836a-f94c-4d13-e053-2995a90a8df54
892246levothyroxine sodium 100 MCG Oral TabletPSN8aaa3667-e814-6cc5-e053-2a95a90a2e7c3
966248levothyroxine sodium 112 MCG Oral TabletPSN8aaa3667-e814-6cc5-e053-2a95a90a2e7c3
966225levothyroxine sodium 150 MCG Oral TabletPSN8aaa3667-e814-6cc5-e053-2a95a90a2e7c3
966220levothyroxine sodium 25 MCG Oral TabletPSN8aaa3667-e814-6cc5-e053-2a95a90a2e7c3
966221levothyroxine sodium 50 MCG Oral TabletPSN8aaa3667-e814-6cc5-e053-2a95a90a2e7c3
966222levothyroxine sodium 75 MCG Oral TabletPSN8aaa3667-e814-6cc5-e053-2a95a90a2e7c3
966253levothyroxine sodium 88 MCG Oral TabletPSN8aaa3667-e814-6cc5-e053-2a95a90a2e7c3
966220levothyroxine sodium 0.025 MG Oral TabletSCD8aaa3667-e814-6cc5-e053-2a95a90a2e7c3
966221levothyroxine sodium 0.05 MG Oral TabletSCD8aaa3667-e814-6cc5-e053-2a95a90a2e7c3
966222levothyroxine sodium 0.075 MG Oral TabletSCD8aaa3667-e814-6cc5-e053-2a95a90a2e7c3
966253levothyroxine sodium 0.088 MG Oral TabletSCD8aaa3667-e814-6cc5-e053-2a95a90a2e7c3
892246levothyroxine sodium 0.1 MG Oral TabletSCD8aaa3667-e814-6cc5-e053-2a95a90a2e7c3
966248levothyroxine sodium 0.112 MG Oral TabletSCD8aaa3667-e814-6cc5-e053-2a95a90a2e7c3
966225levothyroxine sodium 0.15 MG Oral TabletSCD8aaa3667-e814-6cc5-e053-2a95a90a2e7c3
892246levothyroxine sodium 100 MCG Oral TabletSY8aaa3667-e814-6cc5-e053-2a95a90a2e7c3
966248levothyroxine sodium 112 MCG Oral TabletSY8aaa3667-e814-6cc5-e053-2a95a90a2e7c3
966225levothyroxine sodium 150 MCG Oral TabletSY8aaa3667-e814-6cc5-e053-2a95a90a2e7c3
966220levothyroxine sodium 25 MCG Oral TabletSY8aaa3667-e814-6cc5-e053-2a95a90a2e7c3
966221levothyroxine sodium 50 MCG Oral TabletSY8aaa3667-e814-6cc5-e053-2a95a90a2e7c3
966222levothyroxine sodium 75 MCG Oral TabletSY8aaa3667-e814-6cc5-e053-2a95a90a2e7c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1838-169238183801100 TABLET in 1 BOTTLE, PLASTIC (69238-1838-1) 100 tablet2003-12-010000-00-00NoNoCurrent
69238-1838-7692381838071000 TABLET in 1 BOTTLE, PLASTIC (69238-1838-7) 1000 tablet2003-12-010000-00-00NoNoCurrent