Mycophenolic Acid

Product NDC
70518-3255
11-digit product format
705183255
Labeler code
70518
Product ID
70518-3255_cf2d9bc2-e7cf-7b04-e053-2995a90a9593
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
2021-10-23
Marketing end
0000-00-00
Substance
MYCOPHENOLATE SODIUM
Active strength
180 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
70518-3255-02023-03-23C16284748780-1f386c64a-2119-0266-e053-dadaa90a7c1a7aff553e-e0d9-44cd-a3e8-33ada17cb6a7
70518-3255-02023-01-30C16284748780-1f386c64a-2119-0266-e053-dadaa90a7c1a7aff553e-e0d9-44cd-a3e8-33ada17cb6a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3255-070518325500120 POUCH in 1 BOX (70518-3255-0) > 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-3255-1) 120 pouch2021-10-230000-00-00NoNoCurrent