Tacrolimus

Product NDC
42291-753
11-digit product format
422910753
Labeler code
42291
Product ID
42291-753_d4c99e82-d744-4788-e053-2995a90a2368
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus Capsules
Dosage form
CAPSULE
Route
ORAL
Labeler
AvKARE
Application
ANDA206651
Marketing category
ANDA
Marketing start
2020-03-19
Marketing end
0000-00-00
Substance
TACROLIMUS
Active strength
1 mg/1
Pharmacologic classes
Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42291-753DDiscontinued by firm2026-08-17
excluded packagepackage42291-75342291-753-01DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42291-753-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42291-753-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42291-753-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42291-753-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42291-753-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42291-753-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42291-753-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42291-753-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42291-753-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42291-753-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42291-753-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42291-753-01557ba5c1ecfa…9c80585c8c6e…

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
A206651-001TACROLIMUSTACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2017-11-30
A206651-002TACROLIMUSTACROLIMUSEQ 1MG BASECAPSULE / ORALAB2017-11-30
A206651-003TACROLIMUSTACROLIMUSEQ 5MG BASECAPSULE / ORALAB2017-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206651-001AB
A206651-002AB
A206651-003AB

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 06:07:402026-07A206651-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2017-11-30caaa826d4ba7…
2026-08-18 06:07:402026-07A206651-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2017-11-30caaa826d4ba7…
2026-08-18 06:07:402026-07A206651-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2017-11-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206651-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2017-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206651-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2017-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206651-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2017-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206651-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2017-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206651-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2017-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206651-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2017-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A206651-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2017-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206651-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2017-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206651-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2017-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206651-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2017-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206651-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2017-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206651-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2017-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206651-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2017-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206651-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2017-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206651-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2017-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206651-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2017-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206651-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2017-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206651-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2017-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206651-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2017-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206651-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2017-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206651-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2017-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206651-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2017-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206651-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2017-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206651-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2017-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206651-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2017-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206651-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2017-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206651-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2017-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206651-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2017-11-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A206651-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2017-11-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A206651-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2017-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206651-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2017-11-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206651-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2017-11-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206651-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2017-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206651-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2017-11-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206651-002TACROLIMUSEQ 1MG BASECAPSULE / ORALAB2017-11-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206651-003TACROLIMUSEQ 5MG BASECAPSULE / ORALAB2017-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206651-001TACROLIMUSEQ 0.5MG BASECAPSULE / ORALAB2017-11-301e350fbaab3a…

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 06:07:402026-07A206651-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206651-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206651-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206651-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206651-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206651-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206651-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206651-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206651-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206651-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206651-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206651-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206651-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206651-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206651-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206651-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206651-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206651-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206651-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206651-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206651-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206651-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206651-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206651-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206651-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206651-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206651-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206651-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206651-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206651-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206651-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206651-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206651-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206651-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206651-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206651-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206651-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206651-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206651-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206651-001AB11e350fbaab3a…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-753-01EA - Each42291-753a5038485-4d3a-4539-8937-db87e25782e412020-04-20

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TacrolimusTACROLIMUSBPI Labs LLC3e8bc65e-8048-4073-8e45-5703306030002026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206651
application number: ANDA206651
TacrolimusTACROLIMUSAjenat Pharmaceuticals LLCca08d4aa-3de2-4a9d-9554-6288e5d36f292025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206651
application number: ANDA206651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-753-0142291075301100 CAPSULE in 1 BOTTLE (42291-753-01) 100 capsule2020-03-190000-00-00NoNoCurrent