Tacrolimus

Product NDC
68462-881
11-digit product format
684620881
Labeler code
68462
Product ID
68462-881_15dcd504-ee3e-4f0f-a765-55e31511641e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA210393
Marketing category
ANDA
Marketing start
2023-08-16
Substance
TACROLIMUS
Active strength
.3 mg/g
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
68462-881-35684620881351 TUBE in 1 CARTON (68462-881-35) / 30 g in 1 TUBE1 tube2023-08-16NoNoHistorical
68462-881-65684620881651 TUBE in 1 CARTON (68462-881-65) / 60 g in 1 TUBE1 tube2023-08-16NoNoHistorical
68462-881-94684620881941 TUBE in 1 CARTON (68462-881-94) / 100 g in 1 TUBE1 tube2023-08-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Tacrolimus Ointment 0.03% Tacrolimus Ointment 0.1% FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE Rx onlyGlenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited2026-04-15HUMAN PRESCRIPTION DRUG LABEL8