FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
69238-1169
Requested package NDC
69238-1169-1
11-digit product format
692381169
Labeler code
69238
Product ID
69238-1169_3bf87967-0b8e-40dc-99e7-9d02ed9a0677
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA210831
Marketing category
ANDA
Marketing start
2021-03-15
Marketing end
0000-00-00
Substance
LEVOTHYROXINE SODIUM
Active strength
88 ug/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69238-116969238-1169-1DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210831-001LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.025MGTABLET / ORAL2019-02-19
A210831-002LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.05MGTABLET / ORAL2019-02-19
A210831-003LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.075MGTABLET / ORAL2019-02-19
A210831-004LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.088MGTABLET / ORAL2019-02-19
A210831-005LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.1MGTABLET / ORAL2019-02-19
A210831-006LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.112MGTABLET / ORAL2019-02-19
A210831-007LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.125MGTABLET / ORAL2019-02-19
A210831-008LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.137MGTABLET / ORAL2019-02-19
A210831-009LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.15MGTABLET / ORAL2019-02-19
A210831-010LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.175MGTABLET / ORAL2019-02-19
A210831-011LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.2MGTABLET / ORAL2019-02-19
A210831-012LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.3MGTABLET / ORAL2019-02-19

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 13 · 492 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210831-001LEVOTHYROXINE SODIUM0.025MGTABLET / ORAL2019-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210831-002LEVOTHYROXINE SODIUM0.05MGTABLET / ORAL2019-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210831-003LEVOTHYROXINE SODIUM0.075MGTABLET / ORAL2019-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210831-004LEVOTHYROXINE SODIUM0.088MGTABLET / ORAL2019-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210831-005LEVOTHYROXINE SODIUM0.1MGTABLET / ORAL2019-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210831-006LEVOTHYROXINE SODIUM0.112MGTABLET / ORAL2019-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210831-007LEVOTHYROXINE SODIUM0.125MGTABLET / ORAL2019-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210831-008LEVOTHYROXINE SODIUM0.137MGTABLET / ORAL2019-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210831-009LEVOTHYROXINE SODIUM0.15MGTABLET / ORAL2019-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210831-010LEVOTHYROXINE SODIUM0.175MGTABLET / ORAL2019-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210831-011LEVOTHYROXINE SODIUM0.2MGTABLET / ORAL2019-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210831-012LEVOTHYROXINE SODIUM0.3MGTABLET / ORAL2019-02-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210831-001LEVOTHYROXINE SODIUM0.025MGTABLET / ORAL2019-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210831-002LEVOTHYROXINE SODIUM0.05MGTABLET / ORAL2019-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210831-003LEVOTHYROXINE SODIUM0.075MGTABLET / ORAL2019-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210831-004LEVOTHYROXINE SODIUM0.088MGTABLET / ORAL2019-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210831-005LEVOTHYROXINE SODIUM0.1MGTABLET / ORAL2019-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210831-006LEVOTHYROXINE SODIUM0.112MGTABLET / ORAL2019-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210831-007LEVOTHYROXINE SODIUM0.125MGTABLET / ORAL2019-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210831-008LEVOTHYROXINE SODIUM0.137MGTABLET / ORAL2019-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210831-009LEVOTHYROXINE SODIUM0.15MGTABLET / ORAL2019-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210831-010LEVOTHYROXINE SODIUM0.175MGTABLET / ORAL2019-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210831-011LEVOTHYROXINE SODIUM0.2MGTABLET / ORAL2019-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210831-012LEVOTHYROXINE SODIUM0.3MGTABLET / ORAL2019-02-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A210831-001LEVOTHYROXINE SODIUM0.025MGTABLET / ORAL2019-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210831-002LEVOTHYROXINE SODIUM0.05MGTABLET / ORAL2019-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210831-003LEVOTHYROXINE SODIUM0.075MGTABLET / ORAL2019-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210831-004LEVOTHYROXINE SODIUM0.088MGTABLET / ORAL2019-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210831-005LEVOTHYROXINE SODIUM0.1MGTABLET / ORAL2019-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210831-006LEVOTHYROXINE SODIUM0.112MGTABLET / ORAL2019-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210831-007LEVOTHYROXINE SODIUM0.125MGTABLET / ORAL2019-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210831-008LEVOTHYROXINE SODIUM0.137MGTABLET / ORAL2019-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210831-009LEVOTHYROXINE SODIUM0.15MGTABLET / ORAL2019-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210831-010LEVOTHYROXINE SODIUM0.175MGTABLET / ORAL2019-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210831-011LEVOTHYROXINE SODIUM0.2MGTABLET / ORAL2019-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210831-012LEVOTHYROXINE SODIUM0.3MGTABLET / ORAL2019-02-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210831-001LEVOTHYROXINE SODIUM0.025MGTABLET / ORAL2019-02-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210831-002LEVOTHYROXINE SODIUM0.05MGTABLET / ORAL2019-02-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210831-003LEVOTHYROXINE SODIUM0.075MGTABLET / ORAL2019-02-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210831-004LEVOTHYROXINE SODIUM0.088MGTABLET / ORAL2019-02-19fd3edfee7708…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1169LEVOTHYROXINE SODIUM TABLET [AMNEAL PHARMACEUTICALS NY LLC]12Legacy NDC20240616_b0efcd19-42a3-4ddb-af5a-16cd073a492a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1169-169238116901100 TABLET in 1 BOTTLE (69238-1169-1) 100 tablet2021-03-150000-00-00NoNoCurrent