FDA.reportPublic FDA data

Application 212399

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMTABLET;ORAL0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumNoNo
002LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMTABLET;ORAL0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumNoNo
003LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMTABLET;ORAL0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumNoNo
004LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMTABLET;ORAL0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumNoNo
005LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMTABLET;ORAL0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumNoNo
006LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMTABLET;ORAL0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumNoNo
007LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMTABLET;ORAL0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumNoNo
008LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMTABLET;ORAL0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumNoNo
009LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMTABLET;ORAL0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumNoNo
010LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMTABLET;ORAL0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumNoNo
011LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMTABLET;ORAL0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumNoNo
012LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMTABLET;ORAL0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A212399-001LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19
A212399-002LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19
A212399-003LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19
A212399-004LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19
A212399-005LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19
A212399-006LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19
A212399-007LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19
A212399-008LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19
A212399-009LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19
A212399-010LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19
A212399-011LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19
A212399-012LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 48 matching rows.

Application-product, TE code table
Application-productTE code
A212399-001AB1
A212399-001AB2
A212399-001AB3
A212399-001AB4
A212399-002AB1
A212399-002AB2
A212399-002AB3
A212399-002AB4
A212399-003AB1
A212399-003AB2
A212399-003AB3
A212399-003AB4
A212399-004AB1
A212399-004AB2
A212399-004AB3
A212399-004AB4
A212399-005AB1
A212399-005AB2
A212399-005AB3
A212399-005AB4
A212399-006AB1
A212399-006AB2
A212399-006AB3
A212399-006AB4
A212399-007AB1
A212399-007AB2
A212399-007AB3
A212399-007AB4
A212399-008AB1
A212399-008AB2
A212399-008AB3
A212399-008AB4
A212399-009AB1
A212399-009AB2
A212399-009AB3
A212399-009AB4
A212399-010AB1
A212399-010AB2
A212399-010AB3
A212399-010AB4
A212399-011AB1
A212399-011AB2
A212399-011AB3
A212399-011AB4
A212399-012AB1
A212399-012AB2
A212399-012AB3
A212399-012AB4

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 12 · 456 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A212399-001LEVOTHYROXINE SODIUM0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-1984e616aacf4f…
2026-09-14 22:38:342026-08A212399-002LEVOTHYROXINE SODIUM0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-1984e616aacf4f…
2026-09-14 22:38:342026-08A212399-003LEVOTHYROXINE SODIUM0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-1984e616aacf4f…
2026-09-14 22:38:342026-08A212399-004LEVOTHYROXINE SODIUM0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-1984e616aacf4f…
2026-09-14 22:38:342026-08A212399-005LEVOTHYROXINE SODIUM0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-1984e616aacf4f…
2026-09-14 22:38:342026-08A212399-006LEVOTHYROXINE SODIUM0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-1984e616aacf4f…
2026-09-14 22:38:342026-08A212399-007LEVOTHYROXINE SODIUM0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-1984e616aacf4f…
2026-09-14 22:38:342026-08A212399-008LEVOTHYROXINE SODIUM0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-1984e616aacf4f…
2026-09-14 22:38:342026-08A212399-009LEVOTHYROXINE SODIUM0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-1984e616aacf4f…
2026-09-14 22:38:342026-08A212399-010LEVOTHYROXINE SODIUM0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-1984e616aacf4f…
2026-09-14 22:38:342026-08A212399-011LEVOTHYROXINE SODIUM0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-1984e616aacf4f…
2026-09-14 22:38:342026-08A212399-012LEVOTHYROXINE SODIUM0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-1984e616aacf4f…
2026-08-18 06:07:402026-07A212399-001LEVOTHYROXINE SODIUM0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19caaa826d4ba7…
2026-08-18 06:07:402026-07A212399-002LEVOTHYROXINE SODIUM0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19caaa826d4ba7…
2026-08-18 06:07:402026-07A212399-003LEVOTHYROXINE SODIUM0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19caaa826d4ba7…
2026-08-18 06:07:402026-07A212399-004LEVOTHYROXINE SODIUM0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19caaa826d4ba7…
2026-08-18 06:07:402026-07A212399-005LEVOTHYROXINE SODIUM0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19caaa826d4ba7…
2026-08-18 06:07:402026-07A212399-006LEVOTHYROXINE SODIUM0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19caaa826d4ba7…
2026-08-18 06:07:402026-07A212399-007LEVOTHYROXINE SODIUM0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19caaa826d4ba7…
2026-08-18 06:07:402026-07A212399-008LEVOTHYROXINE SODIUM0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19caaa826d4ba7…
2026-08-18 06:07:402026-07A212399-009LEVOTHYROXINE SODIUM0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19caaa826d4ba7…
2026-08-18 06:07:402026-07A212399-010LEVOTHYROXINE SODIUM0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19caaa826d4ba7…
2026-08-18 06:07:402026-07A212399-011LEVOTHYROXINE SODIUM0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19caaa826d4ba7…
2026-08-18 06:07:402026-07A212399-012LEVOTHYROXINE SODIUM0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212399-001LEVOTHYROXINE SODIUM0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212399-002LEVOTHYROXINE SODIUM0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212399-003LEVOTHYROXINE SODIUM0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212399-004LEVOTHYROXINE SODIUM0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212399-005LEVOTHYROXINE SODIUM0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212399-006LEVOTHYROXINE SODIUM0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212399-007LEVOTHYROXINE SODIUM0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212399-008LEVOTHYROXINE SODIUM0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212399-009LEVOTHYROXINE SODIUM0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212399-010LEVOTHYROXINE SODIUM0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212399-011LEVOTHYROXINE SODIUM0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212399-012LEVOTHYROXINE SODIUM0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212399-001LEVOTHYROXINE SODIUM0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212399-002LEVOTHYROXINE SODIUM0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212399-003LEVOTHYROXINE SODIUM0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212399-004LEVOTHYROXINE SODIUM0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLET / ORALAB1,AB2,AB3,AB42020-10-1931067a03dcf5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 36 · 1,440 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A212399-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08A212399-001AB2284e616aacf4f…
2026-09-14 22:38:342026-08A212399-001AB3384e616aacf4f…
2026-09-14 22:38:342026-08A212399-001AB4484e616aacf4f…
2026-09-14 22:38:342026-08A212399-002AB1184e616aacf4f…
2026-09-14 22:38:342026-08A212399-002AB2284e616aacf4f…
2026-09-14 22:38:342026-08A212399-002AB3384e616aacf4f…
2026-09-14 22:38:342026-08A212399-002AB4484e616aacf4f…
2026-09-14 22:38:342026-08A212399-003AB1184e616aacf4f…
2026-09-14 22:38:342026-08A212399-003AB2284e616aacf4f…
2026-09-14 22:38:342026-08A212399-003AB3384e616aacf4f…
2026-09-14 22:38:342026-08A212399-003AB4484e616aacf4f…
2026-09-14 22:38:342026-08A212399-004AB1184e616aacf4f…
2026-09-14 22:38:342026-08A212399-004AB2284e616aacf4f…
2026-09-14 22:38:342026-08A212399-004AB3384e616aacf4f…
2026-09-14 22:38:342026-08A212399-004AB4484e616aacf4f…
2026-09-14 22:38:342026-08A212399-005AB1184e616aacf4f…
2026-09-14 22:38:342026-08A212399-005AB2284e616aacf4f…
2026-09-14 22:38:342026-08A212399-005AB3384e616aacf4f…
2026-09-14 22:38:342026-08A212399-005AB4484e616aacf4f…
2026-09-14 22:38:342026-08A212399-006AB1184e616aacf4f…
2026-09-14 22:38:342026-08A212399-006AB2284e616aacf4f…
2026-09-14 22:38:342026-08A212399-006AB3384e616aacf4f…
2026-09-14 22:38:342026-08A212399-006AB4484e616aacf4f…
2026-09-14 22:38:342026-08A212399-007AB1184e616aacf4f…
2026-09-14 22:38:342026-08A212399-007AB2284e616aacf4f…
2026-09-14 22:38:342026-08A212399-007AB3384e616aacf4f…
2026-09-14 22:38:342026-08A212399-007AB4484e616aacf4f…
2026-09-14 22:38:342026-08A212399-008AB1184e616aacf4f…
2026-09-14 22:38:342026-08A212399-008AB2284e616aacf4f…
2026-09-14 22:38:342026-08A212399-008AB3384e616aacf4f…
2026-09-14 22:38:342026-08A212399-008AB4484e616aacf4f…
2026-09-14 22:38:342026-08A212399-009AB1184e616aacf4f…
2026-09-14 22:38:342026-08A212399-009AB2284e616aacf4f…
2026-09-14 22:38:342026-08A212399-009AB3384e616aacf4f…
2026-09-14 22:38:342026-08A212399-009AB4484e616aacf4f…
2026-09-14 22:38:342026-08A212399-010AB1184e616aacf4f…
2026-09-14 22:38:342026-08A212399-010AB2284e616aacf4f…
2026-09-14 22:38:342026-08A212399-010AB3384e616aacf4f…
2026-09-14 22:38:342026-08A212399-010AB4484e616aacf4f…

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 2 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsa0fa8fa5-d3bd-4e52-9ec5-5fb84702826d2026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
ndc (product): 50090-6100
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions70853a82-ba3b-4663-9f78-6791ca72ba9f2026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions7c8a6441-3c12-46ae-bb3b-a320d80045b62026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions008de8fd-150f-4022-8ccb-c8bfa94875c72026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions67f46137-afc4-471b-a6c7-9c2aef92da5d2026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMPD-Rx Pharmaceuticals, Inc.70a9bb5c-2259-405e-8d89-cc1db8c707432026-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMPD-Rx Pharmaceuticals, Inc.6f4998ac-0714-4f5d-8944-9e6902b9f0a62026-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsfa7dd488-de7e-4f9e-87db-18391b723aad2026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions4520fae0-acce-47a0-af9e-f4f16ea6b2682026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
ndc (product): 50090-6101
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions2ce47caf-6ece-429c-b5d7-c47ba69528002026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMASCLEMED USA INC.42a26f8a-dc67-42e4-abb0-d2602afb1b7d2026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsb717aff6-f754-458d-be87-d12d87c5da002026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
ndc (product): 50090-6087
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions62de26a8-d6fc-463f-abe6-4656228c31422026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions36af0286-e447-4098-b3f2-772debd586672026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
ndc (product): 50090-6103
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionse8142948-2bde-4f4b-931e-da43e91f2d592026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsd29bc0fd-5587-4a70-a505-f5aee1f115a62026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsd5b11dac-1acd-4aa2-b837-e3b90d4f69222026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCdb998119-a293-3568-e053-2995a90ac47a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCda570872-94a1-4852-e053-2995a90aacb62026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCda827567-810b-624d-e053-2a95a90a9bde2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 150 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-447Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-447Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-447Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-447Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-448Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-448Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-448Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-448Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-448Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-448Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-448Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-449Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-449Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-449Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-449Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-449Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-449Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-449Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-450Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-450Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-450Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-450Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-450Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-450Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-450Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-451Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-451Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-451Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-451Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-451Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-452Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-452Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-452Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-452Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-452Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-452Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-452Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-453Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-453Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-453Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-453Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-453Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-453Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-454Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-454Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-454Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-454Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-454Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-454Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-454Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-455Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-455Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-455Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-455Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-455Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-455Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-455Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-456Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-456Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-456Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-456Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-456Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-456Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-457Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-457Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-457Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-457Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-457Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-457Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-458Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-458Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-458Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
16729-458Levothyroxine sodiumLevothyroxine SodiumAccord Healthcare Inc.ANDACurrent
50090-6087Levothyroxine sodiumLevothyroxine SodiumA-S Medication SolutionsANDACurrent
50090-6089Levothyroxine sodiumLevothyroxine SodiumA-S Medication SolutionsANDACurrent
50090-6090Levothyroxine sodiumLevothyroxine SodiumA-S Medication SolutionsANDACurrent
50090-6100Levothyroxine sodiumLevothyroxine SodiumA-S Medication SolutionsANDACurrent
50090-6101Levothyroxine sodiumLevothyroxine SodiumA-S Medication SolutionsANDACurrent
50090-6103Levothyroxine sodiumLevothyroxine SodiumA-S Medication SolutionsANDACurrent
50090-6104Levothyroxine sodiumLevothyroxine SodiumA-S Medication SolutionsANDACurrent