Mycophenolic Acid

Product NDC
70518-3218
11-digit product format
705183218
Labeler code
70518
Product ID
70518-3218_cbe374c6-5af8-0e36-e053-2a95a90a1074
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolic Acid
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA091558
Marketing category
ANDA
Marketing start
2021-09-13
Marketing end
0000-00-00
Substance
MYCOPHENOLATE SODIUM
Active strength
360 mg/1
Pharmacologic classes
Antimetabolite Immunosuppressant [EPC]
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
70518-3218-02023-03-21C16284748780-1f386c649-eb36-0266-e053-dadaa90a7c1af9b08598-8736-4d0f-893b-6bf47b2f3c03
70518-3218-02023-01-30C16284748780-1f386c649-eb36-0266-e053-dadaa90a7c1af9b08598-8736-4d0f-893b-6bf47b2f3c03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3218-07051832180030 POUCH in 1 BOX (70518-3218-0) > 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-3218-1) 30 pouch2021-09-130000-00-00NoNoCurrent