FDA.reportPublic FDA data

Application 090402

Type
ANDA
Sponsor
HERITAGE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TACROLIMUSTACROLIMUSCAPSULE;ORALEQ 5MG BASENoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090402-001TACROLIMUSTACROLIMUSEQ 5MG BASECAPSULE / ORAL2010-07-01

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A090402-001TACROLIMUSEQ 5MG BASECAPSULE / ORAL2010-07-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090402-001TACROLIMUSEQ 5MG BASECAPSULE / ORAL2010-07-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090402-001TACROLIMUSEQ 5MG BASECAPSULE / ORAL2010-07-01cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090402-001TACROLIMUSEQ 5MG BASECAPSULE / ORAL2010-07-01a50c72e98297…

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 3 · 42 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TacrolimusTACROLIMUSPanacea Biotec Limitedbd9fea26-0236-d437-c7df-4b76362108752026-10-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tacrolimus
generic name: TACROLIMUS
TacrolimusTACROLIMUSStellon Biotech Inc.6b89e8a4-9f11-42e3-8e79-fe617e7c461f2026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tacrolimus
generic name: TACROLIMUS
TacrolimusTACROLIMUSMajor Pharmaceuticals213f6047-f897-48a7-b78a-45d7124f2f162026-07-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tacrolimus
generic name: TACROLIMUS
tacrolimusTACROLIMUSA-S Medication Solutions3519febc-c9df-4559-b07a-92f8b0c7e7702026-06-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: tacrolimus
generic name: TACROLIMUS
tacrolimusTACROLIMUSNORTHSTAR RX LLC875f4962-557e-4e12-ad7b-cb5fb6f2a65f2026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: tacrolimus
generic name: TACROLIMUS
TacrolimusTACROLIMUSMajor Pharmaceuticals0addf3f5-9bd5-4ef3-8c7f-52be20c16cf92026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tacrolimus
generic name: TACROLIMUS
TacrolimusTACROLIMUSGlenmark Pharmaceuticals Inc., USAc2d2e3a1-f346-4245-b445-6dd44e3711802026-04-15Warnings, Adverse reactionsName fallback
brand name: Tacrolimus
generic name: TACROLIMUS
TacrolimusTACROLIMUSSafecor Health LLC393cd10e-133c-4d6b-b024-270eb82edbb32026-04-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tacrolimus
generic name: TACROLIMUS
TacrolimusTACROLIMUSJubilant Cadista Pharmaceuticals Inc.651bd506-96b0-43e5-a4dd-db03bf9154c92026-03-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tacrolimus
generic name: TACROLIMUS
TacrolimusTACROLIMUSE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC1bf44a84-14fd-4f80-ad8a-99b1431d631f2026-01-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tacrolimus
generic name: TACROLIMUS
tacrolimusTACROLIMUSGlenmark Pharmaceuticals Inc., USA4b310c6b-e035-4e44-9573-4001d58b2ad52026-01-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: tacrolimus
generic name: TACROLIMUS
TacrolimusTACROLIMUSBPI Labs LLC3e8bc65e-8048-4073-8e45-5703306030002026-01-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tacrolimus
generic name: TACROLIMUS
TacrolimusTACROLIMUSAjenat Pharmaceuticals LLCca08d4aa-3de2-4a9d-9554-6288e5d36f292025-12-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tacrolimus
generic name: TACROLIMUS
TacrolimusTACROLIMUSAscend Laboratories, LLC55467f4b-8437-43a3-b6d9-1bc2a13b4c112025-12-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tacrolimus
generic name: TACROLIMUS
TacrolimusTACROLIMUSGolden State Medical Supply, Inc.34ec4989-6933-4237-ae1e-50a0cb90a2fe2025-12-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tacrolimus
generic name: TACROLIMUS
TacrolimusTACROLIMUSCardinal Health 107, LLCe898ee90-faae-42a8-b652-be1c8730d8562025-12-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tacrolimus
generic name: TACROLIMUS
TacrolimusTACROLIMUSNexus Pharmaceuticals, LLC9d502961-e9c0-4611-92bf-ce742a7b962c2025-12-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tacrolimus
generic name: TACROLIMUS
TacrolimusTACROLIMUSAmneal Pharmaceuticals NY LLC4eb1b6bd-beec-4dd5-9a48-c93a9fe918b32025-10-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tacrolimus
generic name: TACROLIMUS
TacrolimusTACROLIMUS OINTMENT 0.1%Encube Ethicals, Inc.43b38551-6c5e-48a4-a453-9286f1c16b342025-10-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tacrolimus
TacrolimusTACROLIMUSBryant Ranch Prepacka2e55495-10cc-4f6e-b866-1e7d6e45888b2025-08-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tacrolimus
generic name: TACROLIMUS

Reported adverse events (FAERS/openFDA)#

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