mesalamine

Generic: mesalamine

Labeler: encube ethicals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mesalamine
Generic Name mesalamine
Labeler encube ethicals, inc.
Dosage Form SUSPENSION
Routes
RECTAL
Active Ingredients

mesalamine 4 g/60mL

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-045
Product ID 21922-045_6ffc01fa-3cf5-4e6c-9760-7ff9873c82df
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 21922045
Hyphenated Format 21922-045

Supplemental Identifiers

RxCUI
238151
UPC
0321922045017
UNII
4Q81I59GXC
NUI
N0000175781 M0000971

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 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 (21922-045-47) / 60 mL in 1 BOTTLE, DISPENSING (21922-045-01)
  • 28 BOTTLE, DISPENSING in 1 CARTON (21922-045-49) / 60 mL in 1 BOTTLE, DISPENSING (21922-045-01)
source: ndc

Packages (2)

21922-045-47 7 BOTTLE, DISPENSING in 1 CARTON (21922-045-47) / 60 mL in 1 BOTTLE, DISPENSING (21922-045-01) 21922-045-49 28 BOTTLE, DISPENSING in 1 CARTON (21922-045-49) / 60 mL in 1 BOTTLE, DISPENSING (21922-045-01)

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": "6ffc01fa-3cf5-4e6c-9760-7ff9873c82df", "openfda": {"nui": ["N0000175781", "M0000971"], "upc": ["0321922045017"], "unii": ["4Q81I59GXC"], "rxcui": ["238151"], "spl_set_id": ["d6b68275-b2a4-4965-9862-cf14acf8c599"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "7 BOTTLE, DISPENSING in 1 CARTON (21922-045-47)  / 60 mL in 1 BOTTLE, DISPENSING (21922-045-01)", "package_ndc": "21922-045-47", "marketing_start_date": "20230601"}, {"sample": false, "description": "28 BOTTLE, DISPENSING in 1 CARTON (21922-045-49)  / 60 mL in 1 BOTTLE, DISPENSING (21922-045-01)", "package_ndc": "21922-045-49", "marketing_start_date": "20230601"}], "brand_name": "Mesalamine", "product_id": "21922-045_6ffc01fa-3cf5-4e6c-9760-7ff9873c82df", "dosage_form": "SUSPENSION", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "21922-045", "generic_name": "Mesalamine", "labeler_name": "Encube Ethicals, Inc.", "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"}