Tacrolimus

Product NDC
54288-133
11-digit product format
542880133
Labeler code
54288
Product ID
54288-133_f2e9bcc1-fc42-4fab-a6b2-aceaa77fb2b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
CAPSULE
Route
ORAL
Labeler
BPI Labs LLC
Application
ANDA206651
Marketing category
ANDA
Marketing start
2020-04-08
Substance
TACROLIMUS
Active strength
5 mg/1
Pharmacologic classes
Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
WM0HAQ4WNMTACROLIMUS109581-93-3TACROLIMUS

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54288-133-0154288013301100 CAPSULE in 1 BOTTLE (54288-133-01) 100 capsule2020-04-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TacrolimusBPI Labs LLC | AJENAT PHARMACEUTICALS LLC2026-01-06HUMAN PRESCRIPTION DRUG LABEL12