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 1 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.bc9385d0-5c67-4bde-94da-e621347e2cba2026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.4c903249-69e9-4168-a9d1-22e6c2c1eb222026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.6f25cbb3-0358-4778-b8f0-f76479a2dcc52026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.7fd988be-ab3d-406d-a55d-1e5a8a2101cc2026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.6108759a-783e-42ca-b078-6a3cd84ce9012026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.4f40db1e-3dd9-4c7b-93e6-64f0fd10d5512026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
ndc (product): 68788-7953
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.6d65b528-f52b-4b5d-8b76-46fbd4576f992026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
ndc (product): 68788-7944
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.c38c3c31-6834-4590-ace0-f525e5599f662026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
ndc (product): 68788-7954
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.83854522-f22e-491f-8392-c8b1f94417602026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
ndc (product): 68788-7945
ndc (product): 68788-7943
ndc (product): 68788-7942
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.633b3f9c-9578-4e07-a515-aec1a8b65e922026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
ndc (product): 68788-7969
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.0cffbc96-7a02-4538-9966-b69249be6eb22026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
ndc (product): 68788-7911
Levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack775ef7ba-0b5b-40ba-ac7b-2aef121fe4f42026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
ndc (product): 71335-1827
Levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack231fcdf8-c642-4074-8be8-53ee9c918f182026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
ndc (product): 71335-1828
Levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack251e65e0-6925-4984-9df9-d6d7c6d0703c2026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
ndc (product): 71335-1881
Levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack741a8b30-86e1-4f37-917a-73265a82ee072026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
ndc (product): 71335-1861
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.4a2c8e57-d52d-409f-83d8-731b721bf6132026-04-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
Levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackf347d92a-7726-4165-bc3c-f5b37ec86f9f2026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
ndc (product): 71335-9617
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.f8c14539-8ed1-406a-9b58-8ba3a7ce7ee32026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
ndc (product): 70518-3274
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.55cebc88-0514-4940-b974-ec7f0467d10e2026-04-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212399
application number: ANDA212399
ndc (product): 70518-3154
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.c7d5b71b-e983-4b1a-bfc2-d2343cf8668c2026-04-06Boxed 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 2 of 2 · 150 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-6105Levothyroxine sodiumLevothyroxine SodiumA-S Medication SolutionsANDACurrent
50090-6115Levothyroxine sodiumLevothyroxine SodiumA-S Medication SolutionsANDACurrent
50090-6116Levothyroxine sodiumLevothyroxine SodiumA-S Medication SolutionsANDACurrent
50090-6118Levothyroxine sodiumLevothyroxine SodiumA-S Medication SolutionsANDACurrent
68071-2341Levothyroxine sodiumLevothyroxine SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2466Levothyroxine sodiumLevothyroxine SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2485Levothyroxine sodiumLevothyroxine SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2531Levothyroxine sodiumLevothyroxine SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2531Levothyroxine sodiumLevothyroxine SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2532Levothyroxine sodiumLevothyroxine SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2698Levothyroxine sodiumLevothyroxine SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2802Levothyroxine sodiumLevothyroxine SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7911Levothyroxine sodiumLevothyroxine SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7911Levothyroxine sodiumLevothyroxine SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7929Levothyroxine sodiumLevothyroxine SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7929Levothyroxine sodiumLevothyroxine SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7942Levothyroxine sodiumLevothyroxine SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7942Levothyroxine sodiumLevothyroxine SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7943Levothyroxine sodiumLevothyroxine SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7943Levothyroxine sodiumLevothyroxine SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7944Levothyroxine sodiumLevothyroxine SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7944Levothyroxine sodiumLevothyroxine SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7945Levothyroxine sodiumLevothyroxine SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7945Levothyroxine sodiumLevothyroxine SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7953Levothyroxine sodiumLevothyroxine SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7953Levothyroxine sodiumLevothyroxine SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7954Levothyroxine sodiumLevothyroxine SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7954Levothyroxine sodiumLevothyroxine SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7969Levothyroxine sodiumLevothyroxine SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7969Levothyroxine sodiumLevothyroxine SodiumPreferred Pharmaceuticals Inc.ANDACurrent
70518-3154Levothyroxine sodiumLevothyroxine SodiumREMEDYREPACK INC.ANDACurrent
70518-3154Levothyroxine sodiumLevothyroxine SodiumREMEDYREPACK INC.ANDACurrent
70518-3274Levothyroxine sodiumLevothyroxine SodiumREMEDYREPACK INC.ANDACurrent
70934-887Levothyroxine sodiumLevothyroxine SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-894Levothyroxine sodiumLevothyroxine SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-895Levothyroxine sodiumLevothyroxine SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-896Levothyroxine sodiumLevothyroxine SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-897Levothyroxine sodiumLevothyroxine SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-898Levothyroxine sodiumLevothyroxine SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-899Levothyroxine sodiumLevothyroxine SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-900Levothyroxine sodiumLevothyroxine SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-901Levothyroxine sodiumLevothyroxine SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-904Levothyroxine sodiumLevothyroxine SodiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-642Levothyroxine sodiumLevothyroxine SodiumProficient Rx LPANDACurrent
71205-642Levothyroxine sodiumLevothyroxine SodiumProficient Rx LPANDACurrent
71205-646Levothyroxine sodiumLevothyroxine SodiumProficient Rx LPANDACurrent
71205-646Levothyroxine sodiumLevothyroxine SodiumProficient Rx LPANDACurrent
71205-681Levothyroxine sodiumLevothyroxine SodiumProficient Rx LPANDACurrent
71335-1827Levothyroxine sodiumLevothyroxine SodiumBryant Ranch PrepackANDACurrent
71335-1827Levothyroxine sodiumLevothyroxine SodiumBryant Ranch PrepackANDACurrent
71335-1828Levothyroxine sodiumLevothyroxine SodiumBryant Ranch PrepackANDACurrent
71335-1828Levothyroxine sodiumLevothyroxine SodiumBryant Ranch PrepackANDACurrent
71335-1861Levothyroxine sodiumLevothyroxine SodiumBryant Ranch PrepackANDACurrent
71335-1861Levothyroxine sodiumLevothyroxine SodiumBryant Ranch PrepackANDACurrent
71335-1881Levothyroxine sodiumLevothyroxine SodiumBryant Ranch PrepackANDACurrent
71335-1881Levothyroxine sodiumLevothyroxine SodiumBryant Ranch PrepackANDACurrent
71335-1945Levothyroxine sodiumLevothyroxine SodiumBryant Ranch PrepackANDACurrent
71335-1945Levothyroxine sodiumLevothyroxine SodiumBryant Ranch PrepackANDACurrent
71335-1947Levothyroxine sodiumLevothyroxine SodiumBryant Ranch PrepackANDACurrent
71335-1947Levothyroxine sodiumLevothyroxine SodiumBryant Ranch PrepackANDACurrent
71335-1966Levothyroxine sodiumLevothyroxine SodiumBryant Ranch PrepackANDACurrent
71335-1966Levothyroxine sodiumLevothyroxine SodiumBryant Ranch PrepackANDACurrent
71335-2007Levothyroxine sodiumLevothyroxine SodiumBryant Ranch PrepackANDACurrent
71335-2090Levothyroxine sodiumLevothyroxine SodiumBryant Ranch PrepackANDACurrent
71335-2138Levothyroxine sodiumLevothyroxine SodiumBryant Ranch PrepackANDACurrent
71335-9617Levothyroxine sodiumLevothyroxine SodiumBryant Ranch PrepackANDACurrent
72189-346LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMDirect RxANDACurrent
72789-272Levothyroxine sodiumLevothyroxine SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-272Levothyroxine sodiumLevothyroxine SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-297Levothyroxine sodiumLevothyroxine SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent