Levothyroxine Sodium

Product NDC
59651-556
Requested package NDC
59651-556-90
11-digit product format
596510556
Labeler code
59651
Product ID
59651-556_c760d0cc-2245-4914-8c67-d536c41ac90f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA216414
Marketing category
ANDA
Marketing start
2024-07-16
Substance
LEVOTHYROXINE SODIUM
Active strength
175 ug/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216414-001LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.137MGTABLET / ORAL2024-07-16
A216414-002LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.15MGTABLET / ORAL2024-07-16
A216414-003LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.175MGTABLET / ORAL2024-07-16
A216414-004LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.2MGTABLET / ORAL2024-07-16
A216414-005LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.3MGTABLET / ORAL2024-07-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A216414-001LEVOTHYROXINE SODIUM0.137MGTABLET / ORAL2024-07-16c2088c7a36db…
2026-10-15 13:18:302026-09A216414-002LEVOTHYROXINE SODIUM0.15MGTABLET / ORAL2024-07-16c2088c7a36db…
2026-10-15 13:18:302026-09A216414-003LEVOTHYROXINE SODIUM0.175MGTABLET / ORAL2024-07-16c2088c7a36db…
2026-10-15 13:18:302026-09A216414-004LEVOTHYROXINE SODIUM0.2MGTABLET / ORAL2024-07-16c2088c7a36db…
2026-10-15 13:18:302026-09A216414-005LEVOTHYROXINE SODIUM0.3MGTABLET / ORAL2024-07-16c2088c7a36db…
2026-09-14 22:38:342026-08A216414-001LEVOTHYROXINE SODIUM0.137MGTABLET / ORAL2024-07-1684e616aacf4f…
2026-09-14 22:38:342026-08A216414-002LEVOTHYROXINE SODIUM0.15MGTABLET / ORAL2024-07-1684e616aacf4f…
2026-09-14 22:38:342026-08A216414-003LEVOTHYROXINE SODIUM0.175MGTABLET / ORAL2024-07-1684e616aacf4f…
2026-09-14 22:38:342026-08A216414-004LEVOTHYROXINE SODIUM0.2MGTABLET / ORAL2024-07-1684e616aacf4f…
2026-09-14 22:38:342026-08A216414-005LEVOTHYROXINE SODIUM0.3MGTABLET / ORAL2024-07-1684e616aacf4f…
2026-08-18 06:07:402026-07A216414-001LEVOTHYROXINE SODIUM0.137MGTABLET / ORAL2024-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07A216414-002LEVOTHYROXINE SODIUM0.15MGTABLET / ORAL2024-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07A216414-003LEVOTHYROXINE SODIUM0.175MGTABLET / ORAL2024-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07A216414-004LEVOTHYROXINE SODIUM0.2MGTABLET / ORAL2024-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07A216414-005LEVOTHYROXINE SODIUM0.3MGTABLET / ORAL2024-07-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216414-001LEVOTHYROXINE SODIUM0.137MGTABLET / ORAL2024-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216414-002LEVOTHYROXINE SODIUM0.15MGTABLET / ORAL2024-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216414-003LEVOTHYROXINE SODIUM0.175MGTABLET / ORAL2024-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216414-004LEVOTHYROXINE SODIUM0.2MGTABLET / ORAL2024-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216414-005LEVOTHYROXINE SODIUM0.3MGTABLET / ORAL2024-07-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216414-001LEVOTHYROXINE SODIUM0.137MGTABLET / ORAL2024-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216414-002LEVOTHYROXINE SODIUM0.15MGTABLET / ORAL2024-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216414-003LEVOTHYROXINE SODIUM0.175MGTABLET / ORAL2024-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216414-004LEVOTHYROXINE SODIUM0.2MGTABLET / ORAL2024-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216414-005LEVOTHYROXINE SODIUM0.3MGTABLET / ORAL2024-07-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A216414-001LEVOTHYROXINE SODIUM0.137MGTABLET / ORAL2024-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216414-002LEVOTHYROXINE SODIUM0.15MGTABLET / ORAL2024-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216414-003LEVOTHYROXINE SODIUM0.175MGTABLET / ORAL2024-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216414-004LEVOTHYROXINE SODIUM0.2MGTABLET / ORAL2024-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216414-005LEVOTHYROXINE SODIUM0.3MGTABLET / ORAL2024-07-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216414-001LEVOTHYROXINE SODIUM0.137MGTABLET / ORAL2024-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216414-002LEVOTHYROXINE SODIUM0.15MGTABLET / ORAL2024-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216414-003LEVOTHYROXINE SODIUM0.175MGTABLET / ORAL2024-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216414-004LEVOTHYROXINE SODIUM0.2MGTABLET / ORAL2024-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216414-005LEVOTHYROXINE SODIUM0.3MGTABLET / ORAL2024-07-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216414-001LEVOTHYROXINE SODIUM0.137MGTABLET / ORAL2024-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216414-002LEVOTHYROXINE SODIUM0.15MGTABLET / ORAL2024-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216414-003LEVOTHYROXINE SODIUM0.175MGTABLET / ORAL2024-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216414-004LEVOTHYROXINE SODIUM0.2MGTABLET / ORAL2024-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216414-005LEVOTHYROXINE SODIUM0.3MGTABLET / ORAL2024-07-16b8a1b40f171c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216414-001AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216414-002AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216414-003AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216414-004AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216414-005AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216414-001AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216414-002AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216414-003AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216414-004AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216414-005AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216414-001AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216414-002AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216414-003AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216414-004AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216414-005AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216414-001AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216414-002AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216414-003AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216414-004AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216414-005AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216414-001AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A216414-002AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A216414-003AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A216414-004AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A216414-005AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216414-001AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216414-002AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216414-003AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216414-004AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216414-005AB2179d66fd596c7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Levothyroxine Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM175 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9J765S329GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
892251Internal RxNorm lookup
892255Internal RxNorm lookup
966225Internal RxNorm lookup
966249Internal RxNorm lookup
966270Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c760d0cc-2245-4914-8c67-d536c41ac90fAvailable on FDA.report

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
59651-556-90Levothyroxine Sodium90 in 1 BOTTLETABLET901
59651-556-99Levothyroxine Sodium1000 in 1 BOTTLETABLET10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-556LEVOTHYROXINE SODIUM TABLET [AUROBINDO PHARMA LIMITED]1Current NDC, 2 package rows20240724_c760d0cc-2245-4914-8c67-d536c41ac90f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine SodiumLEVOTHYROXINE SODIUMAurobindo Pharma Limitedc760d0cc-2245-4914-8c67-d536c41ac90f2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216414
application number: ANDA216414
ndc (package): 59651-556-90
ndc (product): 59651-556
ndc11 (package): 59651055690

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966270levothyroxine sodium 137 MCG Oral TabletPSNc760d0cc-2245-4914-8c67-d536c41ac90f1
966225levothyroxine sodium 150 MCG Oral TabletPSNc760d0cc-2245-4914-8c67-d536c41ac90f1
966249levothyroxine sodium 175 MCG Oral TabletPSNc760d0cc-2245-4914-8c67-d536c41ac90f1
892251levothyroxine sodium 200 MCG Oral TabletPSNc760d0cc-2245-4914-8c67-d536c41ac90f1
892255levothyroxine sodium 300 MCG Oral TabletPSNc760d0cc-2245-4914-8c67-d536c41ac90f1
966270levothyroxine sodium 0.137 MG Oral TabletSCDc760d0cc-2245-4914-8c67-d536c41ac90f1
966225levothyroxine sodium 0.15 MG Oral TabletSCDc760d0cc-2245-4914-8c67-d536c41ac90f1
966249levothyroxine sodium 0.175 MG Oral TabletSCDc760d0cc-2245-4914-8c67-d536c41ac90f1
892251levothyroxine sodium 0.2 MG Oral TabletSCDc760d0cc-2245-4914-8c67-d536c41ac90f1
892255levothyroxine sodium 0.3 MG Oral TabletSCDc760d0cc-2245-4914-8c67-d536c41ac90f1
966270levothyroxine sodium 137 MCG Oral TabletSYc760d0cc-2245-4914-8c67-d536c41ac90f1
966225levothyroxine sodium 150 MCG Oral TabletSYc760d0cc-2245-4914-8c67-d536c41ac90f1
966249levothyroxine sodium 175 MCG Oral TabletSYc760d0cc-2245-4914-8c67-d536c41ac90f1
892251levothyroxine sodium 200 MCG Oral TabletSYc760d0cc-2245-4914-8c67-d536c41ac90f1
892255levothyroxine sodium 300 MCG Oral TabletSYc760d0cc-2245-4914-8c67-d536c41ac90f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-556-905965105569090 TABLET in 1 BOTTLE (59651-556-90) 90 tablet2024-07-16NoNoCurrent