mycophenolic acid

Generic: mycophenolic acid

Labeler: biocon pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mycophenolic acid
Generic Name mycophenolic acid
Labeler biocon pharma inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

mycophenolate sodium 180 mg/1

Manufacturer
Biocon Pharma Inc.

Identifiers & Regulatory

Product NDC 70377-126
Product ID 70377-126_3fff88d0-af7a-defa-0465-70be67431a57
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217031
Listing Expiration 2026-12-31
Marketing Start 2024-09-30

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70377126
Hyphenated Format 70377-126

Supplemental Identifiers

RxCUI
485020 485023
UPC
0370377127113
UNII
WX877SQI1G

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 mycophenolic acid (source: ndc)
Application Number ANDA217031 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 120 TABLET, DELAYED RELEASE in 1 BOTTLE (70377-126-11)
source: ndc

Packages (1)

70377-126-11 120 TABLET, DELAYED RELEASE in 1 BOTTLE (70377-126-11)

Ingredients (1)

mycophenolate sodium (180 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": "3fff88d0-af7a-defa-0465-70be67431a57", "openfda": {"upc": ["0370377127113"], "unii": ["WX877SQI1G"], "rxcui": ["485020", "485023"], "spl_set_id": ["7f8d259a-9880-bb8b-2738-b3c6c1edf152"], "manufacturer_name": ["Biocon Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (70377-126-11)", "package_ndc": "70377-126-11", "marketing_start_date": "20240930"}], "brand_name": "Mycophenolic Acid", "product_id": "70377-126_3fff88d0-af7a-defa-0465-70be67431a57", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "70377-126", "generic_name": "Mycophenolic Acid", "labeler_name": "Biocon Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mycophenolic Acid", "active_ingredients": [{"name": "MYCOPHENOLATE SODIUM", "strength": "180 mg/1"}], "application_number": "ANDA217031", "marketing_category": "ANDA", "marketing_start_date": "20240930", "listing_expiration_date": "20261231"}