Tacrolimus

Product NDC
63629-9325
11-digit product format
636299325
Labeler code
63629
Product ID
63629-9325_9e1bdc2a-6295-41c7-88d1-8bf1ef908f41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091195
Marketing category
ANDA
Marketing start
2011-09-30
Substance
TACROLIMUS
Active strength
1 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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
WM0HAQ4WNMTACROLIMUS109581-93-3TACROLIMUS

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-9325-16362993250160 CAPSULE in 1 BOTTLE (63629-9325-1) 60 capsule2022-07-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TacrolimusBryant Ranch Prepack2025-07-03HUMAN PRESCRIPTION DRUG LABEL105