mycophenolate mofetil

Generic: mycophenolate mofetil

Labeler: heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mycophenolate mofetil
Generic Name mycophenolate mofetil
Labeler heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

mycophenolate mofetil 500 mg/1

Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 23155-836
Product ID 23155-836_4c6ca7cd-80b3-4703-904c-6d6d78965f4b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090456
Marketing Start 2022-10-15
Marketing End 2028-05-31

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 23155836
Hyphenated Format 23155-836

Supplemental Identifiers

RxCUI
199058 200060
UPC
0323155830019 0323155836059
UNII
9242ECW6R0

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 mycophenolate mofetil (source: ndc)
Generic Name mycophenolate mofetil (source: ndc)
Application Number ANDA090456 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (23155-836-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (23155-836-05)
source: ndc

Packages (2)

23155-836-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (23155-836-01) 23155-836-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (23155-836-05)

Ingredients (1)

mycophenolate mofetil (500 mg/1)

Linked Drug Pages (1)

Mycophenolate mofetil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4c6ca7cd-80b3-4703-904c-6d6d78965f4b", "openfda": {"upc": ["0323155830019", "0323155836059"], "unii": ["9242ECW6R0"], "rxcui": ["199058", "200060"], "spl_set_id": ["3ac54299-15cc-4c7a-8831-60c15a859b85"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (23155-836-01)", "package_ndc": "23155-836-01", "marketing_end_date": "20271231", "marketing_start_date": "20221015"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (23155-836-05)", "package_ndc": "23155-836-05", "marketing_end_date": "20280531", "marketing_start_date": "20221015"}], "brand_name": "Mycophenolate mofetil", "product_id": "23155-836_4c6ca7cd-80b3-4703-904c-6d6d78965f4b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "23155-836", "generic_name": "Mycophenolate mofetil", "labeler_name": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mycophenolate mofetil", "active_ingredients": [{"name": "MYCOPHENOLATE MOFETIL", "strength": "500 mg/1"}], "application_number": "ANDA090456", "marketing_category": "ANDA", "marketing_end_date": "20280531", "marketing_start_date": "20221015"}