mycophenolic acid

Generic: mycophenilic acid

Labeler: archis pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mycophenolic acid
Generic Name mycophenilic acid
Labeler archis pharma llc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

mycophenolic acid 360 mg/1

Manufacturer
Archis Pharma LLC

Identifiers & Regulatory

Product NDC 72819-156
Product ID 72819-156_471a0acf-310d-7b67-e063-6294a90adb0e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091248
Listing Expiration 2026-12-31
Marketing Start 2022-02-21

Pharmacologic Class

Established (EPC)
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72819156
Hyphenated Format 72819-156

Supplemental Identifiers

RxCUI
485020 485023
UPC
0378819155021
UNII
HU9DX48N0T
NUI
N0000175613

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name mycophenolic acid (source: ndc)
Generic Name mycophenilic acid (source: ndc)
Application Number ANDA091248 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 360 mg/1
source: ndc
Packaging
  • 120 TABLET, DELAYED RELEASE in 1 BOTTLE (72819-156-08)
source: ndc

Packages (1)

72819-156-08 120 TABLET, DELAYED RELEASE in 1 BOTTLE (72819-156-08)

Ingredients (1)

mycophenolic acid (360 mg/1)

Linked Drug Pages (1)

Mycophenolic Acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "471a0acf-310d-7b67-e063-6294a90adb0e", "openfda": {"nui": ["N0000175613"], "upc": ["0378819155021"], "unii": ["HU9DX48N0T"], "rxcui": ["485020", "485023"], "spl_set_id": ["30cb1078-929b-4c0f-be1d-49ef352dfab9"], "pharm_class_epc": ["Antimetabolite Immunosuppressant [EPC]"], "manufacturer_name": ["Archis Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (72819-156-08)", "package_ndc": "72819-156-08", "marketing_start_date": "20220221"}], "brand_name": "Mycophenolic Acid", "product_id": "72819-156_471a0acf-310d-7b67-e063-6294a90adb0e", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "72819-156", "generic_name": "mycophenilic acid", "labeler_name": "Archis Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mycophenolic Acid", "active_ingredients": [{"name": "MYCOPHENOLIC ACID", "strength": "360 mg/1"}], "application_number": "ANDA091248", "marketing_category": "ANDA", "marketing_start_date": "20220221", "listing_expiration_date": "20261231"}