Tacrolimus

Product NDC
82804-032
11-digit product format
828040032
Labeler code
82804
Product ID
82804-032_20d1c12a-bf4b-4467-93a0-ee8b892abea9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065461
Marketing category
ANDA
Marketing start
2009-08-10
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
82804-032-308280400323030 CAPSULE in 1 BOTTLE (82804-032-30) 30 capsule2023-10-25NoNoHistorical
82804-032-608280400326060 CAPSULE in 1 BOTTLE (82804-032-60) 60 capsule2023-10-25NoNoHistorical
82804-032-908280400329090 CAPSULE in 1 BOTTLE (82804-032-90) 90 capsule2023-10-25NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TacrolimusProficient Rx LP2023-10-01HUMAN PRESCRIPTION DRUG LABEL1