Tacrolimus

Product NDC
0781-2104
11-digit product format
007812104
Labeler code
0781
Product ID
0781-2104_8f214e2d-762b-4a1b-bf23-0f784d91a8c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
CAPSULE
Route
ORAL
Labeler
Sandoz Inc.
Application
ANDA065461
Marketing category
ANDA
Marketing start
2009-08-10
Substance
TACROLIMUS
Active strength
5 mg/1
Pharmacologic classes
Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065461-001TACROLIMUSTACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2009-08-10
A065461-002TACROLIMUSTACROLIMUSEQ 1MG BASECAPSULE / ORALAB2009-08-10
A065461-003TACROLIMUSTACROLIMUSEQ 5MG BASECAPSULE / ORALAB2009-08-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A065461-001AB
A065461-002AB
A065461-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A065461-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2009-08-10caaa826d4ba7…
2026-08-18 06:07:402026-07A065461-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2009-08-10caaa826d4ba7…
2026-08-18 06:07:402026-07A065461-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2009-08-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065461-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2009-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065461-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2009-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065461-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2009-08-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065461-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2009-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065461-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2009-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065461-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2009-08-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A065461-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2009-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065461-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2009-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065461-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2009-08-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065461-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2009-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065461-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2009-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065461-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2009-08-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065461-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2009-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065461-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2009-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065461-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2009-08-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065461-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2009-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065461-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2009-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065461-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2009-08-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065461-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2009-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065461-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2009-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065461-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2009-08-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065461-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2009-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065461-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2009-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065461-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2009-08-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065461-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2009-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065461-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2009-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065461-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2009-08-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065461-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2009-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A065461-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2009-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A065461-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2009-08-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065461-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2009-08-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065461-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2009-08-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065461-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2009-08-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065461-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2009-08-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065461-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2009-08-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065461-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2009-08-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065461-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2009-08-101e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A065461-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065461-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065461-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065461-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065461-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065461-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065461-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065461-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065461-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065461-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065461-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065461-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065461-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065461-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065461-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065461-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065461-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065461-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065461-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065461-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065461-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065461-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065461-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065461-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065461-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065461-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065461-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065461-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065461-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065461-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065461-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065461-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065461-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065461-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065461-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065461-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065461-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065461-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065461-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065461-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Tacrolimus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TACROLIMUS5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WM0HAQ4WNMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198377Internal RxNorm lookup
198378Internal RxNorm lookup
313190Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
46ac55cf-d85e-4c34-bb33-f49e078c4a03Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
df369ad4-19d8-393a-de46-8c6255b8b360Product name820251120
d2a74186-7b26-dbcc-9435-50b3d0be14abProduct name220250114
a64835ae-fa9d-41d8-9a93-36828ba72b96Product name320190611
b4a869e4-9fcd-47bd-95e3-85e7c75f8badProduct name120150819

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-2104-01Tacrolimus100 in 1 BOTTLECAPSULE10022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-2104-01EA - Each0781-2104b2894e76-74e5-4a97-8a9f-91d90875c6b012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TACROLIMUSACTIVE INGREDIENTWM0HAQ4WNMTACROLIMUS CAPSULE [SANDOZ INC]10
TACROLIMUS ANHYDROUSACTIVE MOIETYY5L2157C4JTACROLIMUS CAPSULE [SANDOZ INC]10
AMMONIAINACTIVE INGREDIENT5138Q19F1XTACROLIMUS CAPSULE [SANDOZ INC]10
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TACROLIMUS CAPSULE [SANDOZ INC]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TACROLIMUS CAPSULE [SANDOZ INC]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TACROLIMUS CAPSULE [SANDOZ INC]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTACROLIMUS CAPSULE [SANDOZ INC]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TACROLIMUS CAPSULE [SANDOZ INC]10
GELATININACTIVE INGREDIENT2G86QN327LTACROLIMUS CAPSULE [SANDOZ INC]10
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KTACROLIMUS CAPSULE [SANDOZ INC]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTACROLIMUS CAPSULE [SANDOZ INC]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TACROLIMUS CAPSULE [SANDOZ INC]10
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TTACROLIMUS CAPSULE [SANDOZ INC]10
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TACROLIMUS CAPSULE [SANDOZ INC]10
SHELLACINACTIVE INGREDIENT46N107B71OTACROLIMUS CAPSULE [SANDOZ INC]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTACROLIMUS CAPSULE [SANDOZ INC]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-2104TACROLIMUS CAPSULE [SANDOZ INC]21Current NDC, Legacy NDC, 1 package rows20240814_46ac55cf-d85e-4c34-bb33-f49e078c4a03.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TacrolimusTACROLIMUSSandoz Inc.46ac55cf-d85e-4c34-bb33-f49e078c4a032025-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065461
application number: ANDA065461
ndc (product): 0781-2104
TacrolimusTACROLIMUSBryant Ranch Prepackf21115e2-1d02-4bce-9c13-bf593a52a12f2025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065461
application number: ANDA065461
TacrolimusTACROLIMUSBryant Ranch Prepack3dc347e3-9bfd-4910-adb5-24e9792083452024-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065461
application number: ANDA065461
TacrolimusTACROLIMUSBryant Ranch Prepack27154d3a-eec5-4000-a4ff-bfbfe27eb8062024-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065461
application number: ANDA065461
TacrolimusTACROLIMUSBryant Ranch Prepack976f1b69-dd96-4815-b11b-839ce1c456332024-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065461
application number: ANDA065461
TacrolimusTACROLIMUSA-S Medication Solutions98e0584d-16d2-442b-86ce-e5e65239db0c2024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065461
application number: ANDA065461
TacrolimusTACROLIMUSDirect_Rx10ceb3bc-11cc-13e4-e063-6394a90acce42024-03-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065461
application number: ANDA065461
TacrolimusTACROLIMUSProficient Rx LP20d1c12a-bf4b-4467-93a0-ee8b892abea92023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065461
application number: ANDA065461

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198378tacrolimus 5 MG Oral CapsulePSN27154d3a-eec5-4000-a4ff-bfbfe27eb806104
198378tacrolimus 5 MG Oral CapsuleSCD27154d3a-eec5-4000-a4ff-bfbfe27eb806104
198378tacrolimus 5 MG (as anhydrous tacrolimus) Oral CapsuleSY27154d3a-eec5-4000-a4ff-bfbfe27eb806104
313190tacrolimus 0.5 MG Oral CapsulePSN46ac55cf-d85e-4c34-bb33-f49e078c4a0322
198377tacrolimus 1 MG Oral CapsulePSN46ac55cf-d85e-4c34-bb33-f49e078c4a0322
198378tacrolimus 5 MG Oral CapsulePSN46ac55cf-d85e-4c34-bb33-f49e078c4a0322
313190tacrolimus 0.5 MG Oral CapsuleSCD46ac55cf-d85e-4c34-bb33-f49e078c4a0322
198377tacrolimus 1 MG Oral CapsuleSCD46ac55cf-d85e-4c34-bb33-f49e078c4a0322
198378tacrolimus 5 MG Oral CapsuleSCD46ac55cf-d85e-4c34-bb33-f49e078c4a0322
313190tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral CapsuleSY46ac55cf-d85e-4c34-bb33-f49e078c4a0322
198377tacrolimus 1 MG (as anhydrous tacrolimus) Oral CapsuleSY46ac55cf-d85e-4c34-bb33-f49e078c4a0322
198378tacrolimus 5 MG (as anhydrous tacrolimus) Oral CapsuleSY46ac55cf-d85e-4c34-bb33-f49e078c4a0322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-2104-0100781210401100 CAPSULE in 1 BOTTLE (0781-2104-01) 100 capsule2009-08-100000-00-00NoNoCurrent