mesalamine

Generic: mesalamine

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mesalamine
Generic Name mesalamine
Labeler bryant ranch prepack
Dosage Form SUSPENSION
Routes
RECTAL
Active Ingredients

mesalamine 4 g/60mL

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 72162-2302
Product ID 72162-2302_8968031d-ec7a-4e71-adae-93baa739fc85
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216941
Listing Expiration 2026-12-31
Marketing Start 2023-06-01

Pharmacologic Class

Established (EPC)
aminosalicylate [epc]
Chemical Structure
aminosalicylic acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 721622302
Hyphenated Format 72162-2302

Supplemental Identifiers

RxCUI
238151
UNII
4Q81I59GXC
NUI
N0000175781 M0000971

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 mesalamine (source: ndc)
Generic Name mesalamine (source: ndc)
Application Number ANDA216941 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 4 g/60mL
source: ndc
Packaging
  • 7 BOTTLE, DISPENSING in 1 CARTON (72162-2302-2) / 60 mL in 1 BOTTLE, DISPENSING
  • 28 BOTTLE, DISPENSING in 1 CARTON (72162-2302-4) / 60 mL in 1 BOTTLE, DISPENSING
source: ndc

Packages (2)

72162-2302-2 7 BOTTLE, DISPENSING in 1 CARTON (72162-2302-2) / 60 mL in 1 BOTTLE, DISPENSING 72162-2302-4 28 BOTTLE, DISPENSING in 1 CARTON (72162-2302-4) / 60 mL in 1 BOTTLE, DISPENSING

Ingredients (1)

mesalamine (4 g/60mL)

Linked Drug Pages (1)

Mesalamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "8968031d-ec7a-4e71-adae-93baa739fc85", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["4Q81I59GXC"], "rxcui": ["238151"], "spl_set_id": ["c9b1ef9d-1d06-48e7-87d2-7985b99124a6"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "7 BOTTLE, DISPENSING in 1 CARTON (72162-2302-2)  / 60 mL in 1 BOTTLE, DISPENSING", "package_ndc": "72162-2302-2", "marketing_start_date": "20240430"}, {"sample": false, "description": "28 BOTTLE, DISPENSING in 1 CARTON (72162-2302-4)  / 60 mL in 1 BOTTLE, DISPENSING", "package_ndc": "72162-2302-4", "marketing_start_date": "20240430"}], "brand_name": "Mesalamine", "product_id": "72162-2302_8968031d-ec7a-4e71-adae-93baa739fc85", "dosage_form": "SUSPENSION", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "72162-2302", "generic_name": "Mesalamine", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": "4 g/60mL"}], "application_number": "ANDA216941", "marketing_category": "ANDA", "marketing_start_date": "20230601", "listing_expiration_date": "20261231"}