mycophenolic acid

Generic: mycophenolic acid

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mycophenolic acid
Generic Name mycophenolic acid
Labeler ascend laboratories, llc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

mycophenolate sodium 360 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-427
Product ID 67877-427_987e5481-0124-4710-afc9-f3be9e9f07bc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208315
Listing Expiration 2026-12-31
Marketing Start 2021-09-24

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877427
Hyphenated Format 67877-427

Supplemental Identifiers

RxCUI
485020 485023
UPC
0367877427126
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 ANDA208315 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 360 mg/1
source: ndc
Packaging
  • 500 TABLET, DELAYED RELEASE in 1 BOTTLE (67877-427-05)
  • 120 TABLET, DELAYED RELEASE in 1 BOTTLE (67877-427-12)
  • 10 BLISTER PACK in 1 CARTON (67877-427-38) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67877-427-33)
source: ndc

Packages (3)

67877-427-05 500 TABLET, DELAYED RELEASE in 1 BOTTLE (67877-427-05) 67877-427-12 120 TABLET, DELAYED RELEASE in 1 BOTTLE (67877-427-12) 67877-427-38 10 BLISTER PACK in 1 CARTON (67877-427-38) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67877-427-33)

Ingredients (1)

mycophenolate sodium (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": "987e5481-0124-4710-afc9-f3be9e9f07bc", "openfda": {"upc": ["0367877427126"], "unii": ["WX877SQI1G"], "rxcui": ["485020", "485023"], "spl_set_id": ["2d9975e1-baee-4b0c-83de-8a0a92c5d075"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (67877-427-05)", "package_ndc": "67877-427-05", "marketing_start_date": "20210924"}, {"sample": false, "description": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (67877-427-12)", "package_ndc": "67877-427-12", "marketing_start_date": "20210924"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (67877-427-38)  / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67877-427-33)", "package_ndc": "67877-427-38", "marketing_start_date": "20210924"}], "brand_name": "MYCOPHENOLIC ACID", "product_id": "67877-427_987e5481-0124-4710-afc9-f3be9e9f07bc", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "67877-427", "generic_name": "MYCOPHENOLIC ACID", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MYCOPHENOLIC ACID", "active_ingredients": [{"name": "MYCOPHENOLATE SODIUM", "strength": "360 mg/1"}], "application_number": "ANDA208315", "marketing_category": "ANDA", "marketing_start_date": "20210924", "listing_expiration_date": "20261231"}