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 POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

mycophenolate mofetil 200 mg/mL

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

Identifiers & Regulatory

Product NDC 23155-848
Product ID 23155-848_b5316b1d-ed7b-426d-9b86-dd17018c97a5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212634
Marketing Start 2023-09-05
Marketing End 2028-02-29

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 23155848
Hyphenated Format 23155-848

Supplemental Identifiers

RxCUI
311880
UPC
0323155848519
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 ANDA212634 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (23155-848-51) / 225 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

23155-848-51 1 BOTTLE, PLASTIC in 1 CARTON (23155-848-51) / 225 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

mycophenolate mofetil (200 mg/mL)

Linked Drug Pages (1)

MYCOPHENOLATE MOFETIL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b5316b1d-ed7b-426d-9b86-dd17018c97a5", "openfda": {"upc": ["0323155848519"], "unii": ["9242ECW6R0"], "rxcui": ["311880"], "spl_set_id": ["df3ba2e9-00bb-40af-8658-2c5fd2e398ef"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (23155-848-51)  / 225 mL in 1 BOTTLE, PLASTIC", "package_ndc": "23155-848-51", "marketing_end_date": "20280229", "marketing_start_date": "20230905"}], "brand_name": "MYCOPHENOLATE MOFETIL", "product_id": "23155-848_b5316b1d-ed7b-426d-9b86-dd17018c97a5", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "23155-848", "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": "200 mg/mL"}], "application_number": "ANDA212634", "marketing_category": "ANDA", "marketing_end_date": "20280229", "marketing_start_date": "20230905"}