Tacrolimus

Product NDC
68308-703
11-digit product format
683080703
Labeler code
68308
Product ID
68308-703_8f81ec98-b84c-4446-9ccb-6c2280a22694
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tacrolimus
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Mayne Pharma Inc.
Application
ANDA200744
Marketing category
ANDA
Marketing start
2014-09-09
Marketing end
0000-00-00
Substance
TACROLIMUS
Active strength
1 mg/g
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68308-703-01GM - Gram68308-703a40b3cc8-3b53-4456-b176-b0125b1a213e12021-12-08
68308-703-60GM - Gram68308-703e952f3de-5535-4e01-9a76-8b484dfd550a12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68308-703TACROLIMUS OINTMENT [MAYNE PHARMA INC.]4Legacy NDC20240417_de81b7df-a4d6-431f-8ec4-06755a417da8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68308-703-01683080703011 TUBE in 1 CARTON (68308-703-01) > 100 g in 1 TUBE1 tube2021-12-080000-00-00NoNoCurrent
68308-703-60683080703601 TUBE in 1 CARTON (68308-703-60) > 60 g in 1 TUBE1 tube2021-12-080000-00-00NoNoCurrent