Tacrolimus

Product NDC
70518-3216
11-digit product format
705183216
Labeler code
70518
Product ID
70518-3216_cbe11b6a-8dae-3648-e053-2a95a90a3573
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tacrolimus
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA091195
Marketing category
ANDA
Marketing start
2021-09-09
Marketing end
0000-00-00
Substance
TACROLIMUS
Active strength
5 mg/1
Pharmacologic classes
Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3216-02023-03-21C16284748780-1f386c64a-015f-0266-e053-dadaa90a7c1a22add3dd-e3c7-4bee-a094-f00811424ac0
70518-3216-02023-01-30C16284748780-1f386c64a-015f-0266-e053-dadaa90a7c1a22add3dd-e3c7-4bee-a094-f00811424ac0

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3216-070518321600100 POUCH in 1 BOX (70518-3216-0) > 1 CAPSULE in 1 POUCH (70518-3216-1) 100 pouch2021-09-090000-00-00NoNoCurrent